Study Design Lead
Il y a 7 mois
**Job Description**:
Get ready to redefine what’s possible and discover your extraordinary potential. Here at Labcorp, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.
**The Company - LabCorp**
As one of the world's largest and most comprehensive drug development services companies, LabCorp has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today.
**The Position as Study Design Lead**:
This position falls within our **Central Labs Services** group supporting Central Labs Projects for clinical trials phases I-IV.
This position is remotely based.
Do you excel at coordinating events and information into a complex timeline? If you have a background in science or experience in project management, then **joining our study team as a Study Design Lead.**
In this role, you will interact with external clients regularly throughout all duties and responsibilities. As such, the Study Design Lead will be knowledgeable and experienced in study design techniques related to the creation and maintenance of protocol specific databases, as well as, the Statement of Work (SOW).
**About the Job**:
You’ll join our Global Project Management Department, a team of exceptional people who are unified by an energizing purpose to transform healthcare and improve lives around the globe. Clinical studies are developed and managed collaboratively by a study team.
- 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.
- 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 in order to meet client needs related to study design.
- Demonstrate a strong knowledge of internal processes and technical capabilities.
- 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.
- Coordinate 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.
- Ensure that all customer requirements with relation to study design are documented and acted upon.
- Participate in functional meetings (e.g. Continuous Learning Forums (CLFs)) and provide input, keeping processes up to date.
- Manage a portfolio of global and local studies with varying complexity.
- Able to act efficiently in an environment with dynamic timelines and priorities
**Requirements**:
- Minimum Bachelor or Master degree in a scientific field
- Six (6) years of previous experience in Central Lab Project Management or other equivalent industry experience (education may be substituted for experience)
- Strong planning, organizational, and problem solving skills
- Good verbal and written communication skills
- Demonstrated success negotiating routine job-related situations
**Thrive personally and professionally at Labcorp**:
Working at Labcorp, you’ll continue to grow in our learning-based culture so you’ll know how to expertly respond and adapt as the industry continues to evolve. Here, you’ll put your education to work as you play a meaningful role in advancing healthcare and making a difference in people’s life.
In addition, Labcorp offers great benefits, global experience and the opportunity to work independently within a team-oriented environment.
**Get to know Labcorp**
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.
Here, you can join our more than 75,000 employees, servi
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