Clinical Team Lead - Biopharma

Company: Labcorp Drug Development - USA
Location: Burlington
Posted on: March 20, 2023

Job Description:

Labcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries. Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise. Did you know? In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023. We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. Clinical Team Lead The Clinical Team Lead (CTL) is the leader for the clinical team in our Clinical Operations CTL group. The Clinical Team Lead (CTL) is responsible and accountable for the execution of the clinical operations component of the project, at the global or regional level, as assigned. The CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial including oversight of the clinical operations from a quality, timeline, budget and scope perspective. The Clinical Team Lead position can be home based anywhere within the United States or Canada. Essential Job Duties: Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs. Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: Pre-Study Visits, Site Initiation Visits, Routine Monitoring Visit, Motivational Visits, Close-out Visits, Audit support Visits. Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines. Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol. Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensure that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization. Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions. As required by the project roles participate and oversee the site selection process. Depending on the scope and roles within the project team, this may be performed in collaboration with other team members. As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation. Support new business with active participation in Bid Defense preparation and meetings, as required. Perform other duties as required by the Department or Project Team. Education: --- BSc or BA degree in a biomedical or related life science, or nursing qualification. --- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Minimum Required: --- 0-4 years' experience as a CTL, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. --- Minimum 4+ years CRA experience, on-site or in-house. Or --- In lieu of the above minimum requirement, candidates with 6 or more years of relevant clinical research experience in pharmaceutical, CRO or health care setting will be considered. Pay range: $110,000 -$145,000 USD 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), 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. For more information about how we collect and store your personal data, please see our Privacy Statement .

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