Jobs at Syneos Health Clinical Solutions

Description
Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. First level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations.

Job Responsibilities

• Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports..
• Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports
• Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.
• Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
• Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders.
• Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.
• Performs system integration activities, application updates, and user acceptance testing.
• Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs.
• Assists in project meetings and actively contributes and participates in departmental review meetings.
• Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies.
• Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements.
• Manages project resources, proactively alerting management of delivery and resourcing needs.
• Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.

Qualifications

• Bachelor’s degree preferred, or equivalent combination of related education and experience.
• The ability to deal effectively with sponsors and internal customers at all levels.
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Demonstrated experience in managing multiple priorities in a highly dynamic environment
• Experience working in a matrix-structured environment is preferred
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail
• Experience with programming languages, mainly J-Review and Oracle Clinical
• Ability to travel as necessary (up to 25%)

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Job Responsibilities

• On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides project specific training to internal and external audiences as required
• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Supports the management of resources on assigned projects/programs
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• Trains and mentors data management staff, acts as a subject matter expert
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications
What we’re looking for

• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
• Clinical data management experience or an equivalent combination of education and experience.
• Experience in Clinical Data Management practices and relational database management software systems.
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills.
• Contract Research Organization (CRO) experience preferred.
• Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
• Effective oral and written communication skills.
• Strong presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
• Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management

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Job Responsibilities

• Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides project specific training to internal and external audiences as required
• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• Trains and mentors data management staff
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications
What we’re looking for

• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
• Clinical data management experience or an equivalent combination of education and experience.
• Experience of Clinical Data Management practices and relational database management software systems.
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills.
• Contract Research Organization (CRO) experience preferred.
• Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. Effective oral and written communication skills.
• Strong presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.

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Job responsibilities;
The position provides customer focused leadership in managing and delivering the operational and financial aspects of one or more clinical projects from proposal development to final deliverables and ranging in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas with limited interaction from supervisor. May oversee less experienced Project Managers (PMs) and have line management responsibilities.

Project Leadership And Delivery

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.
• Accountable for the financial performance of assigned projects
• Accountable for all project deliverables for assigned projects and/or project regions.
• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.

Reporting And Communication

• Accountable for maintenance of project information on a variety of databases and systems.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
• Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
• Independently prepares, coordinates, and presents project material at internal and external meetings.
• Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
• Prepares project management reports for clients and management.
• Implements resource strategies to achieve project goals.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.

Business Development

• Participates in bid defense meetings where presented as potential project manager/director.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• Keeps a current awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends

Management

• May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
• May be required to line manage other project management team members and clinical monitoring staff

Qualifications
What we’re looking for;

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Prior experience as Project Lead is required.
• Direct therapeutic area expertise.
• Strong ability to manage time and work independently.
• Strong organizational skills.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
• Ability to travel as necessary (less than 25%).

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Job responsibilities

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.
• Accountable for the financial performance of assigned projects
• Accountable for all project deliverables for assigned projects and/or project regions.
• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.

Reporting And Communication

• Accountable for maintenance of project information on a variety of databases and systems.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
• Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
• Independently prepares, coordinates, and presents project material at internal and external meetings.
• Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
• Prepares project management reports for clients and management.
• Implements resource strategies to achieve project goals.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.

Business Development

• Participates in bid defense meetings where presented as potential project manager/director.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• Keeps a current awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends

Management

• May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
• May be required to line manage other project management team members and clinical monitoring staff

Qualifications
What we’re looking for

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Strong ability to manage time and work independently.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken
• Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
• Ability to travel as necessary (approximately 25%).

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Position Overview

The SAS Programmer is responsible for executing programming activities in coordination with project teams with supervision. S/he will develop, create, verify/validate and maintain managing the programs for assigned projects in compliance with standard operating procedures.

Specific Tasks Would Include

• Participates in the validation of SAS programs and maintaining validation documentation.
• Familiarizes oneself with the SAS dataset structure and format catalog related to a given study.
• Familiarizes oneself with the documents associated with a given study.Such documents include (but are not limited to) edit check documents, SAS and database annotated Case Report Forms (CRFs), visit map/schedule of events, CRFs, code lists, statistical analysis plan (SAP), data management plan (DMP), clinical protocol, programming-specific documentation.
• Develops, programs and maintains:
• SAS edit checks and SAS edit check listings.
• Subject profile programming used for quality control of paper-based project databases.
• Data line listings as requested by the Sponsor and/or internal project teams.
• Clean subject programming used to identify clean subjects for a given project.
• JReview objects and registry of SAS datasets.
• SAS programs used to generate random samples of subject numbers and calculate database reliability rate during the quality control of paper-based project databases.
• Study Data Tabulation Model (SDTM) dataset programming.
• Programs that download external data received from various data sources.
• External data reconciliation programs.
• Programs that generate CRF and Query metrics.
• Ad-hoc Sponsor and internal programming requests.

Qualifications

• Bachelor’s degree in a relevant field of study and 0-2 years data management or SAS programming experience or equivalent combination of education and experience.
• Possess an underlying understanding of data management practices and clinical data management systems (CDMS).
• Possess a basic understanding of the Clinical Data Interchange Standards Consortium (CDISC) domain and item names and the role of CDISC in drug development.
• Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
• Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
• Effective verbal and writing skills; English + local language, if relevant.

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Job Responsibilities

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

Qualifications
What we’re looking for

• High School diploma or equivalent
• Good communication and interpersonal skills
• Ability to embrace new technologies
• Minimal travel up to 25% may be required

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Job Responsibilities

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Supports the SSUL to agree on country template contract and budget. Assists in producing site-specific contracts from country template.
• Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SSUL lead with Sponsor until resolution of issues.
• Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Assists SSU leads, Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.
• Facilitates the execution of contracts by company signatories.
• Supports the maintenance of contract templates and site specific files and databases.
• Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Qualifications
What we’re looking for

• BA/BS degree in related field or equivalent combination of education and experience
• Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred
• Strong skills in Microsoft Office Suite, email, and voicemail
• Strong organizational, presentation, documentation, and interpersonal skills
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel
• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively
• Ability to take direction from multiple individuals and set priorities accordingly
• Ability to effectively communicate across multiple function groups (clinical team, PM, Director) Demonstrated ability to work independently, as well as part of a team
• Utilize problem-solving techniques effectively
• Quality-driven in all managed activities
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions
• Strong computer skills, including Word, Excel

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Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:
• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff
• The SMA II may be requested to train junior staff
• Identify and communicate out of scope activities to Lead CRA/Project Manager
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

Qualifications
What we’re looking for

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

go to method of application »

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:
• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff
• The SMA II may be requested to train junior staff
• Identify and communicate out of scope activities to Lead CRA/Project Manager
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

Qualifications
What we’re looking for

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

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Essential Functions

• Configuration of Veeva Vault platform as per business needs
• Handling incidents, requests, provide work around, root cause analysis, preventive actions and corrective actions related to Veeva Vault and related integrated systems
• Assist in requirement analysis, effort estimation and solution/technical design for enhancements and integrations
• Work directly with business users and BT teams to bring open help desk incidents / requests to a resolution. Collaborate with the vendor for resolving any major incidents/defects within Veeva Vault platform
• Coordinate with the vendor for product releases, lead internal review of changes and utilize change control process to implement change requests. Champion configuration change requests on lifecycles, workflows, security settings, objects, document types/subtypes, etc.
• Responsible for Change Management of Veeva, including company communications of updates, changes, new functionality, etc.
• Advanced troubleshooting, break-fix for issues spanning Veeva and related integrations
• Respond to incoming service requests via telephone, email, ServiceNow, instant messaging, and other contact methodologies in a timely manner.
• Uses the prescribed workflow tool(s) to track 100% of all user engagements, analyze requests and issues to identify appropriate remediation in accordance to the IT Global Support Model and the specified Service Level Agreement (SLA) / Operational Level Agreement (OLA).
• Ensure all procedures, support plan, and work instructions related to Veeva remain current.
• Able to work collaboratively with multiple teams across different geographies and time zones
• Work on special assignments on an as needed basis.

Other Responsibilities

• Performs other work-related duties as assigned. Position requires on-call work. Minimal travel may be required (up to 25%).

Requirements
Qualifications

• Master’s / Bachelor’s degree in Computer Science, Engineering, Technology or equivalent
• Minimum five (3) years of experience in a global Pharmaceutical or Life Sciences industry
• Certification(s) in Veeva Administration, Veeva Vault desired
• Experience in configuration of Veeva Vault platform.
• Experience with validated systems - SDLC, IQ, OQ, PQ checklist development and execution. (Required experience in Clinical Domain only).
• Experience with system and application monitoring and data analytics
• Experience in GMP, GCP, 21 CFR Part 11, HIPAA, Data Security, and Data Integrity
• Proficient written and oral communication skills; attention to detail, good organizational and time management skills, and a team player.
• Ability to work effectively across multiple cultures and with global cross-functional teams
• Strong interpersonal skills with a special focus on customer satisfaction.
• Willing to take accountability for assignments, problems, and issues, carrying through to resolution under supervision. Ability to interact with end users and BT teams from multiple business units.
• Ability to work under pressure, think logically, multi-task and manage competing priorities

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Job Summary

The Analyst supports the development, education, monitoring, and implementation oversight of enterprise information security policies and standards. The Analyst primary focus is to assist with the administration of information security governance and compliance processes and monitoring and reporting information security policy and program compliance.

Job Responsibilities

• Performs vendor security assessments and security reviews to assess the security posture and capabilities of Syneos Health vendors
• Monitors Syneos Health vendors to ensure they are meeting Syneos Health vendor security requirements
• Monitors, and reports on information security governance, risk and compliance key performance indicators
• Assist with preparing and submitting mandatory information security program compliance reports to management, and clients
• Assist with preparing responses to internal and external inquiries about information security program, compliance, and performance
• Helps administer information security governance review and approval procedures
• Collaborates with other security organization members on cross-business / cross-functional opportunities
• Helps perform security data analysis and event tracking
• Responds to reported security incidents and events through the Company’s ticketing system
• Helps with writing documentation and reports
• Evaluates new security technology in the Company environment
• Other duties as assigned

Qualifications

• Experience with leading information security frameworks and policy concepts.
• Bachelor’s Degree (or higher) preferred (or equivalent experience).
• Industry certifications such as CISA, CRISC, CISSP or similar industry certification desirable.
• Proficient with Microsoft Office Suite (Word, Excel, Power Point).
• Professional with ability to properly handle confidential information.
• Ability to work well independently and in a team environment. Ability to handle multiple tasks, prioritize and meet deadlines. Ability to work within a matrix organization.
• Must have flexibility and willingness to participate in the work processes of an international organization, including conference calls scheduled to accommodate global time zones.
• Understanding of security tools such as firewalls, anti-malware, Intrusion Detection/ Intrusion Prevention systems (IDS/IPS), Data Leak Prevention (DLP), Unified Threat Management (UTM).
• Familiarity with common information security standards such as ISO-27000 and NIST SP 800 series.
• Ability to review reports and system activity logs to identify critical events, categorize according to priority, and escalate as appropriate