Medical Monitor, Europe (Spain or Poland)

at  Innovaderm Research

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

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

EDUCATION

• Medical degree;
• Training in dermatology and/or rheumatology is a plus

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.
• Experience in Dermatology/Rheumatology 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 minimal supervision, ability to work effectively within a team, and matrix environment.
• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Client-focused approach to work;
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
  Our company:
  At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a Medical Monitor, you will be eligible for the following perks:

• Permanent full-time position
• Flexible schedule
• Home-based position
• Ongoing learning and development

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 first line contact for investigators, site personnel, and monitors regarding study related medical/safety issues and resolution of study protocol and subject eligibility issues.
• 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.
• Assesses the impact of any prohibited medication taken on study and evaluates any appropriate action for the subject.
• Evaluates the appropriateness of any dropout subject replacement.

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 necessar