External Bioanalytical Study Monitor

Company: Labcorp Drug Development - USA
Location: Indianapolis
Posted on: March 19, 2023

Job Description:

Get ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp Drug Development, 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 Drug Development As one of the world's largest and most comprehensive drug development services companies, LabCorp Drug Development has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today. The Position As an External Bioanalytical Study Monitor, you will act as the primary interface and liaison between Labcorp Bioanalytical Laboratories globally and the Sponsor clinical study teams and Sponsor bioanalytical group. This role will include direct leadership and representation on behalf of the Sponsor for the execution of the bioanalytical strategy on the Sponsor's own clinical studies. The oversight and guidance provided will cover the entire clinical lifecycle from planning phase and study execution to reporting. The extent of the bioanalytical monitoring is determined by the work placed by the Sponsor, the majority of the monitoring covers biologics (large molecule), however oversight of small molecule may also be required. About the Job Responsible for representing the Sponsor as a primary liaison with the Sponsor clinical study teams for all matters relating to bioanalytical planning, execution and reporting to the Labcorp Bioanalytical Services global network Work with the Sponsors Bioanalytical Representative to understand the scientific and regulatory bioanalytical strategy for each clinical study for which they are responsible Provide a clear point of focus and consistency of execution for the Sponsor by informing staff of specific requirements as outlined and agreed to by the Sponsor clinical study teams Maintain and monitor all ongoing projects against the Sponsor timetables, including the maintenance of Sponsor specific systems and documentation the maintenance and provision of project tracking tools Provide status reports and updates in a timely manner to the Sponsor and their clinical study teams Coordinate and manage projects within the designated therapeutic areas and provide the Alliance sponsor with consultancy and advisory counsel for execution of the Bioanalytical strategy for each clinical study in their area of responsibility Responsible for the final verification of data quality and integrity for the Sponsor clinical study teams The primary liaison for harvesting workload forecast information and translating clinical study team plans and timetables into actionable demand forecasts for the Labcorp global bioanalytical organisation Maintain and develop all aspects of scientific and regulatory knowledge required to provide the rationale for the successful execution of bioanalytical study activities for the Sponsor clinical study teams Collaboration with Labcorp Central Laboratory teams to ensure seamless delivery across multiple business units. Requirements Master, Chemistry/Biochemistry or related field Extensive knowledge of drug development process Minimum 5 years industry experience in a relevant field Prior experience in scientific/regulatory oversight for Bioanalytical Clinical sample data generation. Demonstrated track record in a r egulated environment for GCP and GLP testing Proven ability to prioritize and manage time Proven ability to get things done by influencing others Proven ability to communicate effectively at all levels with other Labcorp employees, as well as external Sponsors, suppliers, etc. Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages). Recommended: Commercial awareness, interpersonal and negotiating skills. Project management skills and qualifications. Learn and maintain knowledge of process excellence processes, tools and activities. Scope The role covers monitoring of work carried out in global locations The role is primarily office based (hybrid work from home arrangements are a possibility). Travel may be required for Sponsor visits and conferences 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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Keywords: Labcorp Drug Development - USA, Indianapolis , External Bioanalytical Study Monitor, Other , Indianapolis, Indiana