Location: Bedford, MA (Hybrid)

Therapeutic Area: Rare Disease

Job Overview: As a Clinical Trials Manager, you’ll lead the planning and execution of Phase 1–3 clinical studies and open-label extensions. You’ll manage CROs, vendors, and clinical sites to ensure trials are delivered on time, within budget, and in full compliance with GCP and regulatory standards.

Primary Job Responsibilities:

• Oversee study timelines, budgets, and vendor performance
• Lead site and vendor qualification and selection
• Contribute to protocol, ICF, and study document development
• Coordinate drug supply forecasting and delivery
• Support data review and database lock activities
• Identify and mitigate study risks
• Ensure audit readiness and documentation compliance
• Collaborate cross-functionally to meet Clinical Development Plan goals

Primary Job Requirements:

• 4–6 years in clinical operations (biotech, pharma, or CRO)
• Experience managing multiple clinical trials and site visits
• Strong knowledge of ICH-GCP and drug development
• Bachelor’s degree in a scientific or healthcare field preferred
• Rare disease and neurology experience a plus
• Proficient in Microsoft Office and MS Project
• Excellent communication, organization, and problem-solving skills

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

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. 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.