Mantell Associates is currently partnered with a CRO in their search for a Clinical Research Site Director.

Clinical Research Site Director - Responsibilities:

• Oversee a team of 12 at site

• The Site Director is responsible for the profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives

• Accountable for the overall coordination, organization, and efficient implementation of clinical trials management, operations, and regulatory compliance

• Works closely with the Chief Medical Officer, Principal Investigators, Recruitment Team and Clinical Research Coordinators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective

• In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, HIPAA and company standard operating procedures and policies

• Perform and/or oversee all HR responsibilities for reporting staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, and management of staff schedules

• Work closely with the Director of Operations, develop and implement business plans for achieving the strategic and tactical goals and objectives of the business

• Participate in weekly Business Development (BD) calls to review the site's pipeline for planning purposes and to provide feedback

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Clinical Research Site Director - Requirements:

• B.A. or B.S. required; advanced degree preferred

• Minimum of 2 years' experience in managing clinical trials

• Understand regulatory requirements, as well as Good Clinical Practices (GCP), HIPAA and International Conference on Harmonization (ICH) guidelines

• Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner

• Knowledgeable in medical terminology to communicate with physician offices, pharmacists and laboratory staff

• Able to manage a staff of clinical professionals and create a productive, satisfying work environment

• Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy

• Excellent communication skills (interpersonal, written, verbal)

• Ability to perform overnight business travel

• Good organizational and interpersonal skills

• Attention to detail

• Excellent Computer Skills to include Word, Excel, PowerPoint, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.