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Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This is a remote position based in Romania. The Senior Clinical Data Manager manages all aspects of the clinical trial data management process, from study start-up to post-database lock for assigned projects.
Responsibilities:
- Serve as the primary Data Management (DM) contact for assigned clinical projects.
- Oversee project data entry processes.
- Provide input, assess, and manage timelines, ensuring deadlines are met with quality.
- Develop CRF specifications and coordinate review from stakeholders.
- Conduct database build UAT and maintain quality-controlled documentation.
- Oversee overall quality of the clinical database.
- Specify requirements for all edit check types.
- Oversee the development of edit check specifications and manual data review specifications.
- Maintain data management documentation and oversee its completeness for the Trial Master File.
- Train clinical research personnel on study-specific items.
- Review and query clinical trial data according to the Data Management Plan.
- Run patient and study-level status and metric reporting.
- Perform medical coding of medical terms.
- Coordinate SAE/AE reconciliation.
- Liaise with third-party vendors in a project manager capacity.
- Identify and troubleshoot operational problems.
Requirements:
- Bachelor's degree or equivalent experience.
- 8+ years of experience with strong Oncology and/or Orphan Drug therapeutic experience.
- Dictionary medical coding (MedDRA and WHODrug).
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…).
- Experience in utilizing various clinical database management systems.
- Proficiency in Microsoft Office.
- Broad knowledge of drug, device, and/or biologic development.
- Excellent communication and organizational skills.
- Professional use of the English language (written and oral).
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.
Precision for Medicine
Precision for Medicine is dedicated to enhancing clinical research and development. They achieve this by providing specialized services that integrate scientific understanding with advanced analytical platforms. They help optimize clinical trials, accelerate drug development, and enable a deeper understanding of disease mechanisms, ultimately aiming to improve patient outcomes through precision medicine approaches and tailored therapeutics.