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Stratacuity

Sr. Clinical Trial Manager

Stratacuity, Watertown, Massachusetts, us, 02472

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Sr. Clinical Trial Manager Location:

Waltham, MA (Hybrid on-site 3x weekly) Therapeutic Area:

Rare Disease Job Overview:

You will manage internal and external teams, oversee CROs and vendors, and ensure trials are conducted in compliance with regulatory standards and timelines. Primary Job Responsibilities: Serve as primary operational contact for assigned clinical trials Lead weekly Clinical Trial Team meetings and manage study timelines Oversee CROs, vendors, and site-facing activities including PI meetings and site visits Support development of study documents (protocols, ICFs, CRFs, etc.) Maintain and oversee Trial Master File (TMF) for inspection readiness Identify and mitigate risks proactively across study execution Coordinate training for study teams, sites, and vendors Ensure compliance with ICH-GCP, regulatory guidelines, and internal SOPs Contribute to vendor selection and oversight Collaborate cross-functionally to resolve trial issues and implement corrective actions Primary Job Requirements: 5+ years of Clinical Operations experience in biotech, pharma, or CRO Proven track record managing multiple clinical trials Strong understanding of US regulatory and GCP requirements Bachelors degree in life sciences or related field Excellent communication, leadership, and problem-solving skills Proficient in Microsoft Office and clinical trial systems Willingness to travel up to 25% 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. 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. Seniority level

Seniority level

Mid-Senior level Employment type

Employment type

Full-time Job function

Job function

Project Management and Research Referrals increase your chances of interviewing at Stratacuity: Proven Scientific Placement by 2x Inferred from the description for this job

Medical insurance Vision insurance 401(k) Paid maternity leave Get notified about new Clinical Trial Manager jobs in

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