Medical Director (Contract)
About The Position
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. The Medical Director will provide strategic input into current and potential clinical projects, support site investigators and manage the medical monitoring in managing all medical aspects of clinical trials. The Medical Director is responsible for strategic input on potential projects that support proposal writing and bid-defense meetings including a deep understanding of therapeutic area’s current clinical research landscape. Support of data review and medical writing for protocols and study specific reports (regulatory annual reports, clinical study report (CSR)). Has experience in FDA interactions examples, all IND support (Pre- submission, Type A, B and C, and IDE support, Pre-Sub, Informal and Submission meetings). The Medical Director will also be responsible for review and addressing site and CRA queries for inclusion/exclusion criteria. The Medical Director will be responsible for preparing listings of protocol deviations and adverse events for regular meetings, performing initial review for coding and reconciling coding based on the inputs of the clinical and medical teams.
Requirements
- Licensed MD or PhD.
- 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience
- Endocrinology
- Strong communication
- Medical Writing
- Independent worker
- Excel
- CTMS
Nice To Haves
- Pediatrics (preferred)
- Metabolic trial experience (preferred)
Responsibilities
- Provide strategic input into current and potential clinical projects
- Support site investigators
- Manage the medical monitoring in managing all medical aspects of clinical trials
- Provide strategic input on potential projects that support proposal writing and bid-defense meetings
- Support of data review and medical writing for protocols and study specific reports
- Review and addressing site and CRA queries for inclusion/exclusion criteria
- Prepare listings of protocol deviations and adverse events for regular meetings
- Perform initial review for coding and reconciling coding based on the inputs of the clinical and medical teams
- Strategy development for FDA submission
- Protocol development
- Medical writing support for Protocol, and study reports
- Experience with FDA interactions
- Prepare and review protocol deviation listing
- Code protocol deviations per protocol deviation guidance
- Prepare drafts of appropriate study plans
- Prepare adverse event listings
- Assist the medical monitoring in management of clinical trials
Benefits
- competitive salary
- Variable pay
- paid time off
- healthcare and retirement benefits
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What This Job Offers
Job Type
Part-time
Career Level
Senior
Education Level
Ph.D. or professional degree
