Study Director Manager (Toxicology)
1 day left
- Full Time
COVANCE is one of the world’s most comprehensive and experienced contract research organizations (CROs) with a tradition of innovation in the science and processes of drug development. We have the ability to offer wealth of services covering all aspects of drug development ranging from non-clinical research services through to post-marketing safety and commercialization services. We are currently the only CRO with this depth of service offerings.
We are now recruiting a Study Director Manager to join our Toxicology team in Harrogate.
- Performs general supervisory duties including full range of recruitment activities, full range of performance evaluation activities, schedules work, prepares training plans, and executes Affirmative Action goals in department.
- Coordinates efforts of the study team.
- Assists the departmental management with the formulation, development and implementation of plans, policies and procedures within department guidelines to improve the work quality, efficiency, productivity, and expense control of the study direction group. Learns to monitor the quality and production metric for staff evaluation
- Monitors the quality and production metric for staff evaluation
- Works with the global team in the development of standard language for reports and protocols, and company-wide formatting guidelines.
- Ensures adequate cross-site communication among group members, department personnel, and management staff.
- Works with training staff to develop training plans, and ensures sufficient training for staff.
- Peer reviews protocols and reports of other Study Directors.
- Learns the needed financial aspects of the business (e.g. study pricing, workload targets, revenue targets)
- Initiates client contact for new business development.
- Leads and sponsors major client visits to develop relationships and establish/clarify specific client requirements.
- May help develop the group strategy or new technologies in Toxicology or enhances existing ones and assists in marketing new capabilities.
- Conducts scientific meetings and provides leadership in scientific organizations, including publishing research findings and attaining peer recognition through contributing to the field of Toxicology.
- Performs other related duties as assigned.
- Performs all duties required of a Study Director for GLP/non-GLP studies.
- Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
- Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
- Directs preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
- Participates in study specific client visits.
- PhD preferred, or equivalent degree plus Master’s. • Skilled in performing scientific presentations and preparing scientific publications.
- Maintains current regulatory awareness (domestic and foreign).
- Is recognized by research peers as an expert in a selected technical field.
- A solid background in people management plus a strong career record in a related discipline
- Strong customer service skills.
- Demonstrated skills and aptitude for teambuilding.
- Knowledge in planning, negotiation, and process innovation.
- Experienced in the tools and processes of process improvement (Six Sigma and/or other methodologies)
- Demonstrated ability to interact effectively with all staff and management levels.
- Demonstrated problem solving and decision making skills.
- Knowledge of toxicology study design and conduct.
- Advanced knowledge of GLPs and regulatory agency guidelines.
- Strong English writing and communication skills.
- Advanced knowledge of computers and programs (e.g., word processing and spreadsheet applications).