Join our team and build your career with us
We are seeking an experienced Clinical Data Review Specialist to join our team on a full‑time, permanent basis- sponsor dedicated. You will play a key role in ensuring high‑quality, audit‑ready clinical data across oncology studies through ongoing clinical and medical data review.
Key Responsibilities
Perform comprehensive clinical/medical data review across all study domains (eligibility, medical history, prior treatments, dosing, AEs/SAEs/AESIs, concomitant meds, labs, efficacy, survival, coding, etc.).
Identify and resolve data discrepancies by issuing queries and ensuring timely follow‑up in EDC.
Conduct in‑stream data trend analyses to support data integrity, protocol compliance, and patient safety.
Monitor site data entry performance, identify root causes of issues, and drive corrective actions.
Serve as a subject matter expert for clinical/medical data cleaning and contribute to data project management activities.
Communicate training needs for CRAs and study sites as needed.
Participate in cross‑functional data review meetings (e.g., Protocol Deviation Review, DRQT, SMT, SRCD).
Support preparation/review of study data for investigator meetings, advisory boards, IDMC, and topline result presentations.
Contribute to clinical narrative readiness, CSR activities, and QC of narrative packages.
Collaborate with Clinical Scientists, Medical Monitors, Data Management, and Clinical Operations for data readiness across all milestones, including snapshots, interim analyses, regulatory submissions, site close‑out, and DBL.
Experience & Qualifications
Advanced scientific or clinical degree (MD, PharmD, PhD, MSc, Nursing, or related field).
Minimum 5 years of clinical/medical data review experience (8+ years preferred), including cross‑check.
Solid Tumor Oncology experience is required.
Strong understanding of GCP, clinical trial design, and drug development.
Skilled in clinical data review, coding review, query management, and EDC systems.
Excellent communication, organisation, and documentation skills.
Proficiency in MS Excel and project management tools.
Ability to work both independently and collaboratively within cross‑functional teams.
fluent in English
