Job Opportunities at Syneos Health Clinical Solutions

Clinical Research Associate II

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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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As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Serves as Functional Lead for Clinical Data Science including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups
• Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and resolve data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis
• Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined project analysis
• Drives the development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assess risks associated with protocol design, study set parameters that could impact the credibility and reliability of the trial results, aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.
• Drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve data issues
• Monitors and communicates project progress to the Sponsor and project team including use of project
• status reports and tracking tools/metrics
• Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned projects
• Coordinates the work of the assigned Clinical Data Science team
• Develops and maintains 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 for necessary files
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
• Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
• Trains and mentors new or junior team members
• Maintains proficiency in Clinical Data Science 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, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience
• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• Strong knowledge of the drug development process and its impact on data quality, in particular riskbased approach, biometrics procedures, workflows.
• Aptitude for understanding analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Strong experience with protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis/data review and visualization tool sets including but not limited to
• Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and 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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Sr Statistical Programmer - Full Service

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management.
• May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Assists with the transfer of deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

What we’re looking for

• Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience.
• Proficiency in programming in SAS or other required software, preferably in a clinical trial environment.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

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Senior Clinical Data Scientist

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Serves as Functional Lead for Clinical Data Science including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups
• Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with crossfunctional operational plans to drive comprehensive clinical data quality
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and resolve data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysisCoordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined project analysis
• Drives the development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assess risks associated with protocol design, study set parameters that could impact the credibility and reliability of the trial results, aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.
• Drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve data issues
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics
• according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines,and regulations
• Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned projects
• Coordinates the work of the assigned Clinical Data Science team
• Develops and maintains 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 for necessary files
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
• Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
• Trains and mentors new or junior team members
• Maintains proficiency in Clinical Data Science 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, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience
• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• Strong knowledge of the drug development process and its impact on data quality, in particular riskbased approach, biometrics procedures, workflows.
• Aptitude for understanding analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Strong experience with protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and 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

go to method of application »

Job Responsibilities

• Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups.
• Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis
• Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables
• Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies. Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.
• Design and drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results.
• Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies
• Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics
• Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Perform metric collection and data analysis to support continuous process improvement
• Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned projects
• Coordinates the work of the assigned Clinical Data Science team
• Develops and maintains 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 for necessary files
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
• Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
• Actively promote new clinical data science business opportunities aligned with sponsor strategies.
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
• Trains and mentors new or junior team members
• Maintains proficiency in Clinical Data Science 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, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience
• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• In-depth knowledge of the drug development process and its impact on data quality, in particular riskbased approach, biometrics procedures, workflows.
• Sound knowledge of analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Expertise in protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and 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