Study Design Lead I should be knowledgeable and experienced in study design techniques related to the creation and maintenance of protocol specific databases and the Labcorp CLS Statement of Work (SOW). Study Design Lead I must possess strong knowledge of Labcorp CLS processes and systems, show agility to deal with conflicting priorities and possess appropriate self-management skills.
Essential Job Duties:
1. 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.
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
Other duties as assigned.
The Study Design Lead is expected to interact with external clients regularly throughout all duties and responsibilities mentioned above.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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