Associate Director, Clinical Operations

Proclinical is currently recruiting for an Associate Director of Clinical Operations for a biotechnology company located in Boston, MA. Successful candidate will be responsible for leadership of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation.

Job Responsibilities:

• Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations
• Manage strategic engagement with key collaborators
• Set-up and oversee clinical trial-related trackers such as regulatory documents, startup progress, screening/enrollment, study invoices/payments, project budgets, etc.
• Key contributor to IRB/EC and regulatory submissions
• Oversee TMF reviews to ensure completeness and inspection readiness
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides)
• Identify and mitigate against study risks, escalating as necessary
• Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development

Skills and Requirements:

• Bachelor's degree in a scientific field required; advanced scientific degree a plus
• 8-10+ years directly managing clinical trials in Sponsor or CRO setting
• In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
• Experience mentoring and directing members of clinical operations teams
• Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply Chain, Finance)
• Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve
• Self-motivated and able to work autonomously, as well as a member of a collaborative team
• Highly-organized and detail-oriented with a passion to deliver quality results
• Strong verbal and written communication skills with an ability to build relationships internally and externally
• Highest levels of professionalism, confidence, personal values and ethical standards

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Miles Tobin at or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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