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Clinical Research Physican/Medical Monitor
4 months ago
A mid-sized bio-pharmaceutical company in the greater Boston area is looking to add a Medical Monitor to their team. Our client is working on accelerated timelines for a program and they are experiencing an immediate need for hands-on support. This consultant will serve as a scientific resource for study teams, departments, and others as needed.
This is a fully remote 9 month assignment through February 2025 with potential for extension. Our client needs someone to get started ASAP.
Duties & Responsibilities:
- Collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, CSRs, and investigator brochures according to agreed-upon project timelines.
- Provide protocol oversight and input into informed consent documents
- Support the monitoring of patient safety during clinical study and participate in the global product safety reviews including the appropriate tracking and follow-up of adverse events.
- Review and collaborate with Development Medical Director on the approval of risk profiles to ensure appropriate communication to risk to study subjects.
- Participate in data analysis, data review, development of scientific data dissemination, and preparation of final reports and publications.
- Support data analysis and the development of slide sets and publications
- Other activities related to Clinical Research/Trial Execution and Support
Qualifications:
- Advanced Health Degree (MD or DO) required.
- Completed residency and board certified in respective medical area
- Ph.D, PharmD, or Doctorate will not be considered.
- 2 - 5 of relevant pharmaceutical experience in Clinical Development; specifically with Clinical Trials
- Strong experience in leading data cleaning, data review, query resolution, document review, and literature searches.
- Strong experience reviewing/developing documentation such as: study protocols, clinical development plans, investigative brochures, and TFLs.
- Ability to communicate effectively, work independently; demonstrates strong organizational and negotiation skills
