Clinical Trial Manager
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 client’s clinical strategy, mentor colleagues, ensure study performance and efficiency, and make a visible impact in developing assets.
Primary Job Responsibilities:
- 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 Bachelors degree, with at least 3 years of clinical research experience, or a Bachelors 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
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.
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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.