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Medical Monitor, Spain or Poland
hace 3 meses
**This role will be perfect for you if**:
- 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
**RESPONSIBILITIES**
****
**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.
- Prepare for, attend, and present at Investigators’ Meetings.
- Prepare for and attend Safety Review Meetings, as needed.
- Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters
- Provide ongoing medical support during the study to investigators, site personnel, and monitors
- Provide advice to the sites on protocol-related issues including: questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, follow-up visits due and guidance on prohibited medication
- Review lab critical values and alerts.
- Provide emergency unblinding code-break of randomized treatment assignment.
**Medical advisory role (clinical sites)**
- 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.
- Review protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends.
- 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**
- Provide medical review of SAE form, and reviews SAE causality assigned by the Investigator.
- Write and/or review SAE narratives
- Work with the Pharmacovigilance Services provider or Marketing Authorization Holder (MAH) to review SAEs and follow-up on outstanding safety queries, interact with Sponsor and discuss safety issues with sites, as needed.
- Provide assistance in pharmacovigilance activities
- Assist Innovaderm/Sponsor in choosing safety committee members.
- Serve as a non-voting member of the safety committee to convene and organize proceedings, as applicable.
- Develop operating guidelines in conjunction with committee members and submit these to Sponsor for review.
- Support business development activities with proposal development and sales presentations.
- 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.
****
**Requirements**:
**Education**
- Medical degree;
- Completed residency training in Dermatology
**Experience**
- 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.
**Knowledge and skills**
- Excellent knowledge of the drug development process.
- Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
- Outstanding ability to work independently with mínimal supervision, ability to work effectively within a team, and matrix environment.
- Ability to organize and work efficiently on
