Labcorp is seeking a Study Design Lead to accurately interpret and translate sponsor protocol requirements into the protocol specific database, working directly with the client. The final output of the database design will generate a Statement of Work for the project.
Requirements
- Six (6) years of previous experience in Central Lab Project Management or other equivalent industry experience (education may be substituted for experience)
Responsibilities
- Leverage technical, therapeutic area, client, and company specific process knowledge to provide a comprehensive and complete database design.
- Liaise with internal departments to understand full company capabilities and assess feasibility of requests to meet client needs related to study design.
- Coordinate internal processes and communications related to study design (including but not limited to internal feasibility requests, material transfer agreements and supply forecasting) and ensure the eventual follow up is integrated into the database and global monitoring plan.
- Perform quality self-review.
- Ensure that all customer requirements with relation to study design are documented and acted upon.
- Manage a portfolio of global and local studies with varying complexity.
Other
- Interact with external clients regularly throughout all duties and responsibilities.
- Act as a consultant to the client to advise on study design choices and works with the Global Study Manager (GSM) to highlight risks and budget impacts associated with study design. Expand consultancy capability at study program levels.
- Display strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design.
- Act efficiently in an environment with dynamic timelines and priorities.
- Display appropriate self-organization and ability to manage conflicting priorities.
- Participate in functional meetings (e.g. Continuous Learning Forums (CLFs)) and provide input, keeping processes up to date.
- Comply with our internal Central Lab Global Project Management strategy.
- Support a culture of continuous improvement, quality, and productivity.
- Bachelor’s degree in a life science is strongly preferred
- Strong planning, organizational, and problem solving skills
- Excellent verbal and written communication skills required
