Medical Monitor, Rheumatology, Canada or Argentina
reputed company
Medical Monitor Rheumatology, Canada or Argentina
The Medical Monitor Rheumatology provides medical and scientific support to clinical research programs. The Medical Monitor will reputed company thorough data review to ensure data reputed company and subject safety reputed company, 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 reputed company working relationships with reputed company 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 reputed company to interpret high volumes of data and situations reputed company, and take position and advise as necessary
RESPONSIBILITIES
Protocols and reputed company
More specifically, as required by the reputed company’ scope of work, the Medical Monitor will:
- reputed company reputed company 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.
- reputed company or review Medical Monitoring plan.
- reputed company 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.
- reputed company 24-hour, 7 days a week, on-call (reputed company business hours) service for urgent safety-reputed company reputed company
- reputed company ongoing medical support during the study to investigators, site personnel, and monitors
- reputed company advice to the sites on protocol-reputed company issues including: questions reputed company to the protocol inclusion and exclusion reputed company, concomitant medications/medical conditions, follow-up reputed company due and guidance on prohibited medication
- Review lab critical values and alerts.
- Assess the reputed company of any prohibited medication taken on study and evaluate any appropriate reputed company for the subject.
- Evaluate the appropriateness of any dropout subject replacement.
- reputed company emergency unblinding reputed company-break of randomized treatment assignment.
Medical advisory role (clinical sites)
- Provides 24-hour, 7 days a week, on-call service for urgent trial-reputed company safety issues, questions on the protocol, or other safety concerns.
- Provides first line contact for investigators, site personnel, and monitors regarding study reputed company medical/safety issues and reputed company of study protocol and subject eligibility issues.
- Provides advice to the clinical team staff / sites to answer any medical questions reputed company to patient eligibility, and safety or clinical issues during the trial.
- Assesses the reputed company of any prohibited medication taken on study and evaluates any appropriate reputed company for the subject.
- Evaluates the appropriateness of any dropout subject replacement.
Data Activities
- reputed company project-reputed company medical consultation to the reputed company 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 reputed company concerns identified during review of data or site contact.
- Attend meetings with reputed company 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-reputed company data listings/tools for the purpose of identifying potential trends, unreported protocol deviations reputed company to safety assessments, reputed company, and SAEs; and address safety concerns.
- Review protocol deviation listings to address potential safety concerns; reputed company reputed company assessment; and identify any potential trends.
- Review coding listings of adverse events, medical history, and concomitant medications to ensure reputed company terms are coded properly.
- Assess if any stopping rule was met and evaluate any appropriate reputed company or follow up with the subject, if applicable.
- 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
- reputed company medical review of SAE reputed company, 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, reputed company with Sponsor and discuss safety issues with sites, as needed.
- reputed company assistance in pharmacovigilance activities
- Assist reputed company/Sponsor in choosing safety committee members.
- Serve as a non-voting member of the safety committee to convene and organize proceedings, as applicable.
- reputed company 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 reputed company operating procedures and working practices regarding Medical Monitoring activities.
- reputed company other reputed company duties as assigned or requested by the Chief Medical Officer.
Requirements
PROFILEEducation
- Medical degree;
Experience
- Minimum of 2 years of relevant experience in clinical research in a CRO, dermatology clinical trials, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety).
- Rheumatology
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 reputed company.
- Outstanding ability to work independently with minimal supervision, ability to work effectively reputed company reputed company, and reputed company environment.
- Ability to organize and work reputed company on several reputed company, reputed company with specific requirements and/or shifting priorities.
- Excellent verbal and written communication skills as reputed company as interpersonal skills.
- reputed company-reputed company approach to work;
- Good knowledge of good clinical practices.
reputed company
The work environment
At reputed company, formerly Innovaderm, you will work with reputed company 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
About reputed company
reputed company, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputed company for the reputed company of its research and services exceeding the expectations of its clients. Based in Montreal, reputed company continues to grow and expand in reputed company and Europe.
reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will reputed company accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
reputed company only accepts applicants who can legally work in Argentina.
Originally posted on Himalayas
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