Clinical Scientist

TMC Pharma | Independent Associate Consultant Opportunity

About the Opportunity

TMC Pharma is seeking experienced Associate Clinical Scientists to join our established network of independent consultants supporting medical monitoring activities across clinical development programmes. We are looking for clinically knowledgeable professionals with strong experience in clinical trial data review, EDC development, cross-functional data cleaning and medical monitoring support. Successful candidates will work closely with Lead Medical Monitors, contributing to clinical scientific oversight, identifying clinically relevant data discrepancies and ensuring timely escalation of medical concerns.

Key Responsibilities

• Eligibility Reviews: Review patient screening data against protocol inclusion and exclusion criteria, identify discrepancies or missing information, and escalate eligibility concerns to the Lead Medical Monitor.
• Medical Coding Reviews: Review MedDRA and WHO Drug coding across adverse events, medical history and concomitant medications to ensure accuracy, consistency and clinical relevance.
• Cross-Functional Data Cleaning: Review and reconcile clinical trial data across multiple domains, working collaboratively with Clinical Data Management, Clinical Operations, Pharmacovigilance and Biostatistics teams to identify and resolve discrepancies.
• EDC Design and User Acceptance Testing (UAT): Contribute to eCRF design, review EDC specifications against protocol requirements, develop and execute clinical UAT scenarios, and identify defects in clinical data collection workflows.
• Clinical Data Analysis and Visualisation: Navigate clinical data review platforms, dashboards and patient-level listings to identify missing information, inconsistencies, temporal relationships and clinically relevant findings across multiple datasets.
• Safety Reporting Support: Collate, reconcile and quality-check clinical safety data for periodic safety reports, clinical study reports and other medical monitoring deliverables, without responsibility for independent clinical safety interpretation.
• DSMB/DMC Support: Assist with the preparation, reconciliation, quality control and coordination of clinical and safety data packages for independent data monitoring committees.
• Medical Issue Escalation: Identify potential clinical safety concerns, protocol deviations and medically significant data discrepancies, preparing clear, evidence-based summaries for assessment and decision-making by the Lead Medical Monitor.

Essential Candidate Requirements

• Degree in life sciences, biomedical sciences, pharmacy, nursing or a related scientific or clinical discipline.
• Approximately 3–5 years or more of relevant clinical research experience, including direct involvement in medical monitoring or clinical scientific review.
• At least 1–2 years of demonstrable experience as an independent contractor or consultant within the pharmaceutical, biotechnology or CRO sector.
• Hands-on experience conducting clinical trial eligibility reviews, medical coding reviews and cross-functional clinical data cleaning.
• Practical involvement in EDC design, eCRF specification reviews and user acceptance testing.
• Experience navigating and analysing multiple cross-domain clinical trial datasets using EDC systems, clinical data review tools, data listings or visualisation platforms.
• Strong knowledge of clinical trial protocols, ICH-GCP, medical terminology and clinical safety data.
• Ability to recognise clinically relevant issues, exercise sound scientific judgement and escalate medical concerns appropriately without independently making medical decisions.
• Proven ability to work autonomously, manage project deliverables and collaborate effectively with multidisciplinary teams.

Desirable Experience

• Experience supporting oncology, rare disease or other complex clinical development programmes.
• Familiarity with clinical trial systems and analytical tools such as Medidata Rave, Oracle Clinical One, Veeva EDC, Spotfire, JReview or equivalent platforms.
• Experience working across multiple sponsors, CROs, therapeutic areas and clinical development phases.
• Previous involvement in DSMB/DMC preparation, aggregate safety reporting or clinical study report development.

Working with TMC Pharma

TMC Pharma values experienced, independent Associates who combine strong clinical scientific expertise with practical problem-solving skills. Our Associates work alongside experienced medical professionals to support clinical trial quality, data integrity and patient safety across a range of clinical development programmes.

We are particularly interested in consultants who can integrate quickly into project teams, work effectively across different sponsor environments and deliver high-quality medical monitoring support while recognising when medical issues require escalation to a qualified Lead Medical Monitor.

Interested candidates are invited to get in touch with a CV highlighting their medical monitoring experience, technical capabilities and independent contracting track record.