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
• Bachelor’s 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.

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. 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 [email protected] or 844-463-6178.