Medical Director (Contract)
Sitero LLC•Miami, FL
•Remote
About The Position
Medical Director 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.
Requirements
- Licensed MD or PhD.
- 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience.
- Strong communication
- Medical Writing
- Independent worker
- Excel
- CTMS
Nice To Haves
- Endocrinology Pediatrics (preferred)
- Metabolic trial experience (preferred)
Responsibilities
- 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.
- Provide 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).
- 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.
- 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
