Overview Job Title: Associate Director Clinical Trial Management Job Number: 36783 Location: Cambridge, MA Job Description We are hiring an Associate Director or Clinical Trial Management to oversee and guide all phases of clinical trial operations, from initiation through completion. Responsibilities Lead and manage all aspects of clinical trials from startup through closeout, ensuring compliance with ICH/GCP guidelines, SOPs, and quality standards. Oversee study budgets, timelines, and forecasts; review/approve invoices and ensure financial targets are met. Identify and mitigate study risks, develop solutions, and maintain audit-ready documentation to support inspection readiness. Provide leadership in the selection and management of CROs, vendors, trial sites, and investigators to ensure successful study execution. Oversee the development of key clinical documents (protocols, informed consent, CRFs, monitoring plans, study reports, regulatory submissions, etc.). Mentor, train, and manage study personnel while fostering effective cross-functional and external partnerships. Required Skills Bachelor’s degree in life sciences or related field; advanced degree preferred. 10+ years in clinical research with 5+ years managing trials in biotech/pharma or CRO. Experience with autoimmune or rare disease trial setup, execution, and oversight. Strong communication, problem-solving, organizational skills, and attention to detail. Solid knowledge of GCP/ICH guidelines; proficient with MS Office, CTMS, eTMF, and EDC systems. Able to thrive in a fast-paced biotech environment; willingness to travel as needed.

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