-Develops and manages strategic partnerships as assigned. Identifies relevant internal stakeholders (TA strategy and planning experts, physicians, operational experts) and coordinates involvement as appropriate.
-Responsible for accurate profiling of all relationships assigned, to ensure our database and dynamic views are accurate.
-Assists partners in operational readiness in advance of clinical trial programs, by working with our contracting and legal experts to get CDAs, MSAs, and data licensing agreements in place.
-Work with internal stakeholders to optimize study placement.
-Work closely with other team members who lead the global feasibility process in order to optimize understanding of which partners are relevant for any given opportunity and monitor interest of partners and ultimate selection into our studies
-Work with QA to ensure inspection readiness, regulatory compliance and adherence to ICH GCP at each of the assigned partner locations
-Maintain partner scorecards for assigned relationships using a common model for metrics, goals, budget forecasts
-Work closely with Patient Relations to introduce innovative tactics into the research partners
Site identification based on “core/non-core” therapeutic category
*Categorization and development of site potential
*Top line Site/Investigator feasibility & Site operational analysis
*Vital Investigator information collection, collation and storage
*Facilitation of Master Service Agreements with sites in Site Partnerships
*Periodic investigator engagement during study conduct to motivate investigators and learn of issues to drive process improvements
*Train site personnel in the appropriate conduct of clinical trials
*Provide Investigator therapeutic support
*Identification of appropriate investigators for project teams based on study specific needs in core therapeutic areas
*Deliver feedback on trial performance and potential performance enhancements to investigators and sites
*Coordination of Regionally and Therapeutically based ”Best Practice” sessions for investigators and sites
*May oversee the development and execute feasibility plan in accordance with project objectives; including type of feasibility and needed survey methods with associated timelines and role definitions for relevant Covance stakeholders defined: Verifies plan with team and provides written updates as required
-Oversees participates in team activities related to multiple ongoing feasibility projects:
- Bachelor Degree and above
- pharmaceutical/CRO industry experience is essential