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 :
Gathering relevant input from stakeholders for survey question creation and execution. Works within OS&P, Medical, BD and other teams in an integrated manner with the feasibility execution team
May be Point person for global feasibility studies as assigned : maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions, and generate the formal report
Provide feasibility support language where appropriate, to internal stakeholder groups
May prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study experience, and Investigator self-reported data
Level of education required :
BA / BS required, preferably in life sciences / healthcare
Minimum Required :
Years of experience in the job discipline : 6 + years in clinical trial related activities
Years of experience in other professional roles : 8+ years in professional roles
Other required work-related experiences : Prefer professional experiences in healthcare related fields
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).
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