Study Design Lead – Clinical Research, Central Labs Services

3 weeks ago


Indianapolis, Indiana, United States Labcorp Full time

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.

Central Laboratory Services is part of a global contract research organization within Labcorp. We offer the world's largest network of central laboratories and support global clinical trials testing. A common set of processes, procedures, and instrumentation is offered throughout our sites in Europe, Asia/Pacific, and the United States, allowing us to receive samples globally and provide more than 700 assays across all laboratory science disciplines.

LabCorp is seeking a Study Design Lead to join our Central Labs Services team. In this position, you will take the lead to accurately interpret and translate sponsor protocol requirements into the protocol specific database, working directly with the client. The final output of the database design will generate a Statement of Work for the project.

This is a remote opportunity and can be located anywhere in the US.

Responsibilities:

  • Interact with external clients regularly throughout all duties and responsibilities.
  • 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 to meet client needs related to study design.
  • 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 ensure the eventual follow up is integrated into the database and global monitoring plan. Perform quality self-review.
  • Ensure that all customer requirements with relation to study design are documented and acted upon.
  • Act efficiently in an environment with dynamic timelines and priorities.
  • Display appropriate self-organization and ability to manage conflicting priorities.
  • Participate in functional meetings (e.g. Continuous Learning Forums (CLFs)) and provide input, keeping processes up to date.
  • Comply with our internal Central Lab Global Project Management strategy.
  • Manage a portfolio of global and local studies with varying complexity.
  • Support a culture of continuous improvement, quality, and productivity.

Experience and Qualifications:

  • Bachelor's degree in a life science is strongly preferred
  • 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
  • Excellent verbal and written communication skills required

Application Window: The application window will close at the end of the day on August 21, 2024.

Work Location: US Remote

Pay Range: 60-90K per annum

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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.

We encourage all to apply

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