Study Design Lead

Labcorp is seeking a remote Study Design Lead to join our Central Labs Services team in Bulgaria.

Job Responsibilities

• Accurately interpret and translate sponsor protocol requirements into the protocol specific database to generate a Statement of Work for the CLS project.

• Leverage technical, therapeutic area, client, and company specific process knowledge to provide a comprehensive and complete database design.

• Interact with external clients regularly through all duties and responsibilities.

• 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 advise on study design choices and work 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 complexities.

• Support a culture of continuous improvement, quality, and productivity.

Minimum Qualifications

• Bachelor’s degree in a life science

• 6 or more years of experience working in the clinical research industry or within a lab environment

Preferred Qualifications

• Master degree in a life science

• 6 or more years experience in Central Lab Project management

Additional Job Standards

• Experience working directly with internal or external customers

• Strong relationship building and management skills

• Familiarity with clinical or preclinical research protocols

• Strong planning, organizational, and problem-solving skills

• Excellent verbal and written communication skills

• Excellent skills using computer applications (e.g. Windows, Excel, Word)

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).  

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.