Description
Reporting to the Manager, Medical Monitoring, Medical Affairs, the Medical Monitor Associate, provides medical, scientific, and administrative support to the medical monitoring team in their study level, department level, and cross-functional level activities. The Medical Monitor Associate will primarily assist with the daily tasks related to medical oversight in clinical trials.
This role will be perfect for you if:
- You have an experience in clinical trials and are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project.
- You are a dermatologist who 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
- 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.
- Support Medical Monitoring plan development.
- Attend meetings with Innovaderm project team members (PM, DM, stats, CRO), as required.
- Enter medical queries in EDC after lead medical monitor completes the subject safety-related data listings review.
- Support with coding listings of adverse events, medical history, and concomitant medications review to ensure all terms are coded properly.
- Conducts photo review for studies under their responsibility
- Reviews efficacy scores and related data
- Support business development activities with proposal development and sales presentations.
- Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities.
- Perform other related duties as assigned or requested by the Director, Scientific and Regulatory Affairs.
- Maintain up to date study tracker, KPI tracker.
- Develop and/or collect relevant medical monitoring team documentation, and track completion.
- Send documents for eSignature and file documents in the study folder/SharePoint.
- Develop content for project level medical Indication training (for each study), IM, team trainings.
- Coordinate team meetings and trainings.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education
- Medical degree; board-certified dermatologist
Experience
- Minimum 1 year experience in CRO or pharmaceutical industry in clinical research; or in clinical trials as an investigator experience as medical monitor/medical reviewer/drug safety physician for clinical trials an asset.
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.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company
The work environment
At Indero, 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.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Benefits
- Vacations
- Bonus structure plan
- Note that this opening is for a home-based position in Canada or Argentina
Work location
About Indero
A Global Clinical Leader In Dermatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
only accepts applicants who can legally work in Canada or Argentina.
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