Associate Director, Clinical Operations

ProClinical is currently seeking an Associate Director of Clinical Operations for a pharmaceutical company located in Massachusetts. Successful candidate will be responsible for managing cross functional leadership and CRO/vendor management related to clinical trial operations aspects.

Job Responsibilities:

• Leading, overseeing and aligning activities of the Clinical Operations Team and other functions contributing to the program, in accordance to the program objectives.
• Leading in the selection and oversight of CROs and other vendors.
• Developing and leading the review of clinical outsourcing strategies and plans.
• Managing assigned clinical trial budgets.
• Representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
• Initiating and leading monitoring oversight activities in accordance with ICH/GCP standards.
• Overseeing activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct.
• Maintaining oversight and participate in the review of departmental SOPs to ensure compliance.
• Developing and maintaining strong, collaborative relationships with key stakeholders

Skills and Requirements:

• BS/BA in a science-related field.
• 7+ years of clinical research experience, including clinical trial execution and reporting.
• Proven capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management and data cleaning.
• Excellent verbal and written communication skills.
• Experience in a start-up environment preferred.
• Strong medical/scientific writing skills.
• Proven track record of effective leadership.
• Must be pro-active team player, flexible, and open to change.
• Knowledge of GCP and ICH.
• Previous experience with FDA/MHRA/PMDA inspections desired.
• Experience in multiple phases of research preferred.
• Experience authoring protocols and clinical sections of clinical documents.

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 (+1) 617-545-5922 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.

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