Job description
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, organisation, 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 on-boarding 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
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 organisational 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)
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.