Study Design Lead – Clinical Research , Central Labs Services

Labcorp•Indianapolis, IN

19h•$70,000 - $90,000•Remote

About The Position

Labcorp is seeking a remote Study Design Lead to join our Central Labs Services team. This role involves accurately interpreting and translating sponsor protocol requirements into a specific database to generate a Statement of Work for the CLS project. The Study Design Lead will leverage technical, therapeutic area, client, and company-specific process knowledge to provide a comprehensive and complete database design. This position requires regular interaction with external clients and liaison with internal departments to understand full company capabilities and assess the feasibility of requests related to study design. The Study Design Lead will act as a consultant, advising on study design choices and working with the Global Study Manager (GSM) to highlight risks and budget impacts. The role also involves expanding consultancy capability at study program levels and coordinating internal processes and communications related to study design, ensuring follow-up is integrated into the database and global monitoring plan. The individual will perform quality self-reviews, ensure customer requirements are documented and acted upon, and efficiently manage dynamic timelines and priorities. Participation in functional meetings and adherence to the Central Lab Global Project Management strategy are also key aspects of this role. The Study Design Lead will manage a portfolio of global and local studies with varying complexities and support a culture of continuous improvement, quality, and productivity.

Requirements

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

Nice To Haves

Bachelor’s degree in a life science
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

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.