- Takes the lead to accurately interpret and translate protocol requirements in to SOW document
- Leverages technical, therapeutic area, client and Covance process knowledge to provide a comprehensive and complete SOW document.
- Liaise with internal departments to understand Covance capabilities and assess feasibility of requests in order to meet client needs related to study design
- Demonstrates strong knowledge of Covance processes and technical capabilities
- 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
- Displays strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design
- 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
- Ensures that all customer requirements with relation to study design are documented and acted upon
- Able to act efficiently in an environment with dynamic timelines and priorities
- Displays appropriate self organization and ability to manage conflicting priorities
- Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date
- Comply with CCLS Global Project Management strategy
- Support a culture of continuous improvement, quality and productivity
- Other duties as assigned
The Study Design Lead is expected to interact with external clients regularly throughout all duties and responsibilities mentioned above.
- High School Diploma
- University degree in ascientific field
- 7 years of previous experience in a CCLS 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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