1. Takes the lead to accurately interpret and translate protocol requirements in to SOW document
2. Leverages technical, therapeutic area, client and Covance process knowledge to provide a comprehensive and complete SOW document.
3. Liaise with internal departments to understand Covance capabilities and assess feasibility of requests in order to meet client needs related to study design
4. Demonstrates strong knowledge of Covance processes and technical capabilities
5. Acts as a consultant to the client to advise on study design choices and works with GSM to highlight risks and budget impacts associated with study design
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 in to the SOW 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
10. Displays appropriate self organization and ability to manage conflicting priorities
11. Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date
12. Comply with CCLS Global Project Management strategy
13. Support a culture of continuous improvement, quality and productivity
14. Other duties as assigned
The Study Design Lead is expected to interact with external clients regularly throughout all duties and responsibilities mentioned above.
University degree in a scientific field
7 years of previous experience in a clinical lab project management and/or Clinical Database Design role; or other equivalent industry experience in designing clinical databases (education may be substituted for experience)
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