- Manage and oversee a portion of a larger, international study, ensuring alignment with study goals, SOPs, and regulatory guidelines, with guidance from the CTM.
- Coordinate and facilitate the planning, execution, and close-down of clinical studies, including start-up, data analysis, reporting, and adherence to study timelines.
- Provide comprehensive review and feedback on clinical study guidance documents, such as protocols, investigator brochures, and various study plans, while ensuring compliance with the client and regulatory guidelines.
- MS/MA/MBA or Bachelor's degree, with at least 3 years of clinical research experience, or a Bachelor's degree with over 4 years of clinical research experience.
- Project Management Professional certification, along with previous experience as a CRA and/or Data Manager, and expertise in process development, management, and GXP remediation.
- Demonstrate a proven track record of successfully managing clinical studies, particularly in Phase 1/2 settings in the U.S., with preference given to experience in Phase 3 studies and running studies in ex-US settings.
- Proficiency in FDA and ICH GCP regulations are crucial
Clinical Trial Manager - Cambridge, United States - Stratacuity
Description
Location: Cambridge, MA (Hybrid)
Science: Antibody Drug Conjugates
Therapeutic Area: Oncology
Job Overview: This role is an exciting opportunity for a motivated individual to strategically guide the operationalization of our clients clinical strategy, mentor colleagues, ensure study performance and efficiency, and make a visible impact in developing assets.
Primary Job Responsibilities:
Primary Job Requirements:
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
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