Medical Monitor (home-based)
NOTE: This role may be based remotely at any location within the U.S.
Medical Monitor (MM) is responsible for delivery of medical monitoring services, including, but not limited to, working with clinical project teams to monitor the safety of ongoing studies, and support database locks. The MM will work with the clinical teams to review the safety data including review of MedWatch/CIOMS forms. This individual must have the ability to work and communicate efficiently with internal and external partners. The MM must be a licensed Medical Doctor (MD) or Doctor of Osteopathy (DO) preferably with experience in Oncology. A minimum of five (5) years of industry experience and in depth knowledge of, and experience as, a medical monitor for clinical trials (Phase I - III) is necessary. This individual must possess strong verbal and written communication competencies as well as interpersonal skills with experience participating on project teams, coordinating safety activities and adhering to tight timelines. The MM will attend regularly scheduled meetings as required and respond to site, sponsor and Health Authority questions. He/she will attend and present at Investigator meetings, review CRFs, present study updates as needed, train in-house staff and project teams, design and implement safety monitoring plans, conduct data base listings (DBL) final reviews, review blinded tables, listing & figures (TLFs), review protocol deviations, and participate in all DBL meetings as assigned. The MM will review final TLFs, work with the medical writer(s) to review & revise Clinical Study Report (CSR) documents, review discussion and conclusions, and participate in comment resolution meetings. The MM may present topline results to Sponsors or Competent Authorities. Other tasks may be required as determined by the project.
- Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
- Oversees the management of medical monitoring during the course of clinical trials and projects
- Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
- Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
- Ensures delivery of medical/clinical direction to investigative sites per contract deliverables
- Prepares medical and safety plans for clinical trials/services
- Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts
- Oversees reviews and directs medical and safety sections of regulatory document submissions
- May participate in Investigator meetings
- Develops and assists other staff in the development of processes, timelines, planning, and strategy
- Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review
- Education: Medical Doctor (MD) or Doctor of Osteopathy (DO) from an accredited university. Specialty in oncology preferred.
- Certification: Preferably board certified in the US.
- Experience: Minimum of five (5) years of clinical research and medical/safety management experience in the pharmaceutical industry
This role requires an excellent understanding of the clinical/pharmaceutical process so as to effectively communicate and create required deliverables. Possesses advanced knowledge of, and ability to apply, ICH GCP and all applicable FDA and international pharmacovigilance regulations and guidelines. Possesses exceptional leadership skills and proven industry vision. Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint.
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.
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As a medical writer, Shaniya is responsible for compiling the data from clinical study reports, analyzing what’s been learned from conducting the trial, and summarizing that information into a scientific document.
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