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  • Posted: Apr 29, 2022
    Deadline: Not specified
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  • Syneos Health® is the only fully integrated end-to-end clinical and commercial solution organization. We are purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Our business addresses today’s market realities through clinical and commercial sharing exp...
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    Sr Statistical Programmer - EU or South Africa

    Job Responsibilities

    • Uses SAS or other software to develop custom programming code 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 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.
    • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
    • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
    • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
    • Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and 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.
    • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
    • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
    • Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
    • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
    • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
    • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
    • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
    • Transfers deliverables.
    • Performs other work-related duties as assigned.
    • Minimal travel may be required

    Preference will be given to those from previously disadvantaged groups that meet the minimum requirements of the position

    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.
    • Extensive programming experience 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.

    go to method of application »

    DM SAS Programmer

    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

    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.

    go to method of application »

    Global Study Start Up Project Delivery Manager - single sponsor studies

    Job Responsibilities

    • Collaborates with major functional area leads (SSU Country Managers, Project Management, and Clinical Management) to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented. Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
    • Develops and maintains strategic relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Contributes to change initiatives across and within the SSU department.
    • Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.
    • Assumes accountability on SSU deliverables including, but not limited to:
    • Start-up regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses, study maintenance submissions);
    • Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites
    • Establishing Essential document collection leading to site activation;
    • Overall SSU timelines to site activation.
    • Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped process. Complies with all controlled document requirements and other requirements to ensure quality deliverables.
    • Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
    • Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.
    • Reviews the project SSU budget with the functional leads, project PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and gross profit expectations.
    • Uses professionally recognized tools for planning and management of scope, timeline, resources, and ensures that minimum hours are used for tasks. If out-of-scope work is requested, notifies the project PM and her/his SSU manager and track out of scope until assigned to back log.
    • Prepares the core submission documents and core clinical trial application dossier.
    • Assist in development of master Patient Information Sheet (PIS) /Informed Consent Form (ICF) in collaboration with the PM and medical department.
    • Oversees collation, quality review, and submission of country-specific applications.
    • Accountable for the timely follow-up for Ethics Committee/Competent Authority enquiries or objections in collaboration with the country SSU Specialists. Meets or exceeds the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, solves or escalates the problem quickly. In parallel with project deliverables, identifies best practices and initiates/participates in process improvement initiatives in conjunction with the global SSU leadership plan.
    • Accountable for the negotiation and execution of clinical trial agreements and budgets in accordance with agreed timelines. Includes coordination of internal and external stakeholders in the development and/or provision of required clinical trial agreement templates and investigator site budgets, oversight of local contract negotiator colleagues and assistance in resolving negotiation barriers, and periodic progress reporting to the client and other stakeholder groups. May include providing assistance and guidance to SSU Lead colleagues in their coordination of clinical trial agreement activities.
    • Participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities.
    • Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately.

    Qualifications

    What we’re looking for

    • Bachelor’s Degree, Higher Degree Preferred. Minimum 5 years CRO industry experience and/or a minimum 4 years’ experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
    • Experience with leading at least 7 studies from award and into maintenance; at least 2 of those studies must have included more than 15 countries across multiple regions. Experience with at least one of the following trial types: pediatric, medical devices, bioequivalence, advanced therapy products, or vaccines.
    • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP Good understanding clinical protocols and associated study specifications. Excellent understanding of clinical trial start-up processes. Project management experience in a fast-paced environment. Good vendor management skills Strong organizational skills with proven ability to handle multiple projects. Excellent communication, presentation and interpersonal skills. Quality-driven in all managed activities. Strong negotiating skills.
    • Strong problem-solving skills. Demonstrate an ability to provide quality feedback and guidance to peers
    • Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.
    • Strong leadership skills; ability to teach/mentor team members. Strong ability to analyze data and make appropriate decisions.

    go to method of application »

    Project Manager II

    Job responsibilities

    • Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
    • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
    • Lead project team to ensure quality, timelines and budget management.
    • Accountable for the financial performance of each project.
    • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
    • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
    • Accountable for all project deliverables for each project assigned.

    Documentation And Reporting

    • Responsible for quality and completeness of TMF for assigned projects.
    • Accountable for maintenance of study information on a variety of databases and systems.
    • Responsible for study management components of inspection readiness for all aspects of the study conduct.
    • Oversight for development and implementation of project plans.
    • Plan, coordinate and present at internal and external meetings.
    • Prepare project management reports for clients and management.
    • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.

    Business Development

    • Develops strong relationships with current clients to generate new and/or add-on business for the future.
    • May participate in bid defense meetings where presented as potential project manager.

    Management

    • 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 equivalent combination of education and experience.
    • Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
    • Strong organizational skills.
    • Strong ability to manage time and work independently.
    • Direct therapeutic area expertise.
    • Ability to embrace new technologies.
    • Excellent communication, presentation, interpersonal skills, both written and spoken.
    • Ability to travel as necessary (approximately 25%).

    go to method of application »

    Sr CDA

    Job Responsibilities

    • Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary.
    • Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required.
    • Creates and enters test data for User Acceptance Testing (UAT)
    • Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
    • Receives and enters lab normal ranges.
    • Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
    • Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate.
    • For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly.
    • For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
    • For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
    • For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems.
    • Participates/Leads in internal meetings.
    • Attends in-process review meetings.
    • Participates in internal/external audits as required.
    • Files documentation in the Data Management Study File (DMSF).
    • Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College)
    • Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
    • Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed.
    • Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
    • Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
    • Runs data cleaning and/or status reports.
    • Performs Serious Adverse Event (SAE) reconciliations.
    • Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations.
    • Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements).
    • Perform post-migration testing on screens, edit checks, matrices and role changes as required.
    • Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution.
    • Reviews database design specifications (including configuration, data structures, annotated CRFs).
    • Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design.
    • Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance.
    • Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM’s back up for specific activities (including attend sponsor’s meetings to provide updates).
    • Creation of Discoverer, BOXI, J-Review Reports
    • Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines.
    • Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor.
    • Reviews queries and self-evident corrections proposed by less experienced DM staff.
    • Understands the coding process
    • Understands the purpose of interim, dry run, data cut
    • Trains and mentors DM staff providing timely feedback to trainee and management as appropriate.
    • Trains project team in project specific requirements.
    • Provides EDC training to internal and external team members via Teleconference.
    • Serves as a platform or process-specific Subject Matter Expert (SME).
    • Performs QC of DMSF after QuickStart® Camp (QSC) and ongoing during the study conduct.
    • May be required to participate in client, internal or agency audits and inspections.
    • May represent the department at business development related meetings.

    Qualifications

    What we’re looking for

    • BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
    • Experience with DM practices and relational database management software systems preferred.
    • Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred.
    • Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.
    • Work experience in clinical research, drug development, data management, or other healthcare environment preferred.
    • Familiarity with medical terminology
    • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
    • Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team.
    • Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers.
    • Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).

    Method of Application

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