Senior Manager, Medical Data Review

This is a fully remote position, open to applicants in Germany.

📋 Description

• Develop Standard Operating Procedures (SOPs) for Medical Data Review that align with project plans and Immatics protocols.

• Create Medical Review Checklists in collaboration with Physicians (Medical Monitors) and the Data Management team.

• Produce and evaluate data extracts and outputs from EDC and JReview systems in partnership with Data Management.

• Ensure outputs adhere to project plans and Immatics guidelines through thorough review.

• Assess medical data for consistency, plausibility, and completeness across various studies and projects.

• Handle medical inquiries, consulting with Physicians as necessary while utilizing knowledge of study protocols and key documents.

• Draft summaries and reports on Medical Data Review findings.

• Review and address Quality Control (QC) findings.

• Participate in Investigator Meetings as needed.

• Maintain expertise in EDC systems and provide training for clinical team members.

• Collaborate with both internal and external Data Management stakeholders.

• Assist with Medical Monitoring, Vendor Management, and other physician-directed initiatives.

⛳️ Requirements

• A degree in a life sciences field (e.g., Biology, Pharmacy, or Medicine) or a healthcare professional qualification such as nursing.

• Relevant practical experience in life sciences or healthcare settings.

• Over 2 years of professional experience as a Medical Data Reviewer in a Clinical Research Organization (CRO) or pharmaceutical/biotechnology firm.

• Strong emphasis on oncology clinical trials.

• Proficient IT skills, especially in Microsoft Excel.

• Capacity to adjust to various systems and databases.

• Strong analytical mindset.

• Ability to work independently.

• Excellent communication skills in English.

• Flexibility and adaptability.

• Scientific enthusiasm.

• Organized, reliable, and solution-focused approach.

• High level of personal accountability.

• Strong interpersonal skills.

🏝️ Benefits

• Job bike.

• Job ticket.

• Health Programs.

• Childcare benefits.

• Relocation allowance.

• Company summer and winter events.

• Opportunities to attend conferences and training sessions.

• Family-friendly work environment.

• Fixed-term employment for 18 months.