Takes the lead to accurately interpret and translate sponsor protocol requirements into the protocol specific database. The final output of the database design will generate a Statement of Work.
2. Leverages technical, therapeutic area, client and Labcorp CLS process knowledge to provide a comprehensive and complete database design.
3. Liaise with internal departments to understand Labcorp CLS capabilities and assess feasibility of requests in order to meet client needs related to study design.
4. Demonstrates strong knowledge of Labcorp CLS processes and technical capabilities.
5. Acts 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.
6. Displays strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design.
7. Coordinates internal processes and communications related to study design (including but not limited to: internal feasibility requests, material transfer agreements and supply forecasting) and ensures the eventual follow up is integrated into the database and global monitoring plan. Performs quality self-review.
8. Ensures that all customer requirements with relation to study design are documented and acted upon.
9. Able to act efficiently in an environment with dynamic timelines and priorities.
FOR GLOBAL REWARDS USE ONLY: Template Updated - June 2021 Page 3 of 6
10. Displays appropriate self-organization and ability to manage conflicting priorities.
11. Participate in functional meetings (eg. Continuous Learning Forums (CLFs)) and provide input, keeping processes up to date.
12. Comply with CLS Global Project Management strategy.
13. Manages a portfolio of global and local studies with varying complexity.
14. Support a culture of continuous improvement, quality and productivity.
15. Able to act efficiently in an environment with dynamic timelines and priorities
16. Other duties as assigned.
The Study Design Lead is expected to interact with external clients regularly throughout all duties and responsibilities mentioned above.
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