We are currently recruiting for a Bioanalytical Partnership Program Manager for our site in Harrogate, North Yorkshire, UK or our sites in USA (Chantilly, Madison and Indianapolis).
As a Bioanalytical Partnership Program Manager, you will act as the primary interface and liaison between Covance Bioanalytical Laboratories globally and the individual sponsor clinical teams within our Alliance partner. The role will include direct leadership and representation on behalf of the sponsor for the regulatory and scientific strategy for bioanalytical execution on the sponsor’s own internal clinical project teams. The oversight and guidance provided will cover the entire clinical lifecycle from planning phase and study execution to reporting. There is potential for extensive involvement with regulatory support from authorities during the reporting phase. Other duties and responsibilities may include:
- Provide scientific as well as regulatory leadership and direction to the Covance Bioanalytical Services global network as a primary liaison with the Alliance Sponsor Clinical teams
- Responsible for representing the Alliance sponsor for all matters relating to Bioanalytical planning, execution and reporting
- Coordinate and manage projects within the designated therapeutic areas and provide the Alliance sponsor with consultancy and advisory counsel for execution of the Bioanalytical strategy for each clinical study in their area of responsibility
- Maintain and develop all aspects of scientific and regulatory knowledge required to provide the rationale for the successful execution of Bioanalytical study activities for the clinical teams in which they represent
- Provide a clear point of focus and consistency of execution for the Alliance sponsor by informing staff of specific requirements as outlined and agreed to by the sponsor clinical teams
- Provide status reports and updates in a timely manner to the Alliance sponsor and their clinical teams
- Maintain and monitor all ongoing projects against the Alliance sponsor timetables for development. This includes the maintenance and provision of project tracking tools.
- Maintain standards, templates and communication channels relevant to the clinical team leadership and participation
- Liaison with Covance Laboratory operations and Quality Assurance to ensure adequate and sufficient resolution of all audit related issues
- Continuous focus and direct involvement with ongoing process excellence programs between Covance and the Alliance sponsor as well as other members of the Alliance Partnership as outlined by the sponsor
- Translate clinical team plans and timetables into actionable demand forecasts for the Covance team. The Program Manager is the primary liaison for harvesting workload forecast information and translating that to the global bioanalytical organisation
- Responsible for the final verification and certification of data quality and integrity for the Alliance sponsor clinical teams
- Qualified to degree level or equivalent in one of the life sciences. Higher degree is desired but not essential.
- Prior experience in scientific/regulatory oversight for Bioanalytical Clinical sample data generation.
- Prior experience in a regulated environment for GCP and GLP testing.
- Knowledge of drug development process.
- Ideally have worked as a Clinical Program Manager within a CRO or Pharma company.
- Any previous outsourcing experience is desired but not essential.
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!