Clinical Data Manager
Clinical Data Manager
Posted on :
23-05-2025
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1 Vacancy
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Job Description
Responsibilities:
- Leads all DM lifecycle activities from study start-up maintenance database lock and close-out.
- Independently develop DM documents including but not limited to Data Management Plans (DMP) Case Report Forms (CRFs) CRF Completion Guidelines Edit Checks UAT specifications centralized monitoring plans data flow and integrity plans blinding plans and data review plans.
- Utilize templates and standard guidelines to initiate documents but demonstrate critical thinking alignment-building and discretion to tailor documents to study needs.
- Manage data deliverables processes and database locks with high quality and efficiency.
- Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians Statistical Programmers Medical Monitors Clinical Scientists Clinical Project Managers Clinical Trial Managers CRAs Clinical Pharmacologists Biomarker/Bioinformatics Scientists Medical Writers Regulatory representatives etc.).
- Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs attend site audits).
- Performs Medical Coding as needed works with CROs Medical Monitors and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
- Run SAS and/or R programs review SAS and/or R logs troubleshoot errors and generate output. Program SAS and/or R Non-System Edit Checks/Back-end checks and SAS and/or R Data Listings as appropriate for skill level.
Requirements:
- BA or BS and a minimum of 5 years of relevant experience.
- Technologically savvy; quickly picks-up new information standards regulations tools methods or software as it relates to position and profession.
- Experience working within a Clinical EDC system (e.g. Medidata Rave Veeva EDC).
- Experience with managing Lab Data such as PK PD and Biomarkers.
- Detail-oriented; performs quality and accurate work.
- Knowledgeable in GCP standards CDISC standards (CDASH SDTM Adam) FDA and ICH guidelines and GCDMP.
- Strong knowledge of clinical research drug development process and medical terminology oncology experience preferred.
- Knowledge and understanding of DM Lifecycle associated with P1-P3 studies including pivotal blinded and randomized trials.
- Knowledge of MedDRA and WHO Drug coding.
- Previous experience with RTSM eCOA/ePRO systems.
- SAS programming experience.
Employment Type
Full Time
Key Skills
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