Clinical Data Management Manager

Medical Monitor, Dermatology, Poland or Spain About The Position

The Medical Monitor Dermatology provides medical and scientific support to clinical research programs. The Medical Monitor will perform thorough data review to ensure data integrity and subject safety oversight, and will communicate with sites, investigators, and internal project team members to ensure questions are promptly addressed.

You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project.

You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials.

You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary.

Protocols and projects

More specifically, as required by the projects’ scope of work, the Medical Monitor will :

Keep current on study protocol, study protocol amendments, Investigator’s Brochure (IB), additional safety information made available during the course of the study, and relevant clinical research guidelines involving the therapeutic indication.

Develop or review Medical Monitoring plan.

Provide project team training on study protocol and / or therapeutic area / indication.

Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters.

Provides 24-hour, 7 days a week, on-call service for urgent trial-related safety issues, questions on the protocol, or other safety concerns.

Provides advice to the clinical team staff / sites to answer any medical questions related to patient eligibility, and safety or clinical issues during the trial.

Data Activities

Provide project-related medical consultation to the Innovaderm project team members during business hours throughout the duration of the study.

Escalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns identified during review of data or site contact.

Attend meetings with Innovaderm project team members (PM, DM, stats, CRO) and / or Sponsor, as required.

Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study.

Review subject safety-related data listings / tools for the purpose of identifying potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs; Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly.

Review clinical study report.

Participate in the Central Monitoring activities with site data signal detection and risk management activities for the safety portion; participate in the safety review for RBM and central monitoring.

Safety Medical Monitoring and SAE Reporting Activities

Participate in feasibility discussions relating to specific project proposals.

Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities.

Perform other related duties as assigned or requested by the Chief Medical Officer.

Minimum of 5 years of relevant experience in clinical research in a CRO, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety).

Minimum 3 years experience in CRO or pharmaceutical industry in clinical research, with experience as medical monitor / medical reviewer / drug safety physician for clinical trials.

Ability to organize and work efficiently on several projects, each with specific requirements and / or shifting priorities.

Permanent full-time position.

Home-based position.

The successful candidate for this position is given to work remotely anywhere in Spain or Poland.

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients.

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