About the role
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.
Job Title: Medical Director
Location: United States Remote
Function: Clinical Services
Education
: MD or PhD in Endocrinology or related background
Therapeutic Area: Endocrinology
DESCRIPTION
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Proven track record of 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
EDUCATION AND EXPERIENCE REQUIRED
- Licensed MD or PhD.
- 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience
Endocrinology
Pediatrics (preferred)
Metabolic trial experience (preferred)
PREFERRED SKILLS
Strong communication
Medical Writing
Independent worker
Excel
CTMS
COMPENSATION & BENEFITS
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE
Contract; Part time, Hourly
COMMITMENTS
Hourly as project requires
Willing to work in shifts as and when needed.
DISCLAIMER
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.