WHO ARE WE?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.THE JOBClinical Team Leadis a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project, from sites selection to sites closure. The CTL is responsible for coordinating and managing the clinical operations and local site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.Responsibilities include but are not limited to:
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Ensure the fulfilment of objectives defined in the protocol (number of patients and centers, timelines, budget)
Ensure the ICH-GCP, corporate & local SOPs, and local regulations are respected and followed by all parties
Actively ensure the obtaining of any study related documentation required for CTA application according to local regulation and Corporate & local SOPs, together with the Support Services Manager
Select potential investigating centers according to their qualifications, clinical experience, research background and areas of expertise, in agreement with the Medical Advisors and Lead CPL.
Organize Local Investigator's Meetings and coordinate Investigator teams attendance to International Inv. Meetings
Supervise, coordinate and lead CRA and CPA activities
Regular quality control of e-TMF
Identify any specific problem related to the study, and propose possible solutions
Ensure good site activation. In particular ensures that the Investigators are perfectly informed of the specific features of the study and its organization
Monitor study progress: conduct co-monitoring when necessary, evaluate Monitoring Visit Reports, measure gap between planned and actual values (visits, monitored & compiled CRFs, DRFs), alert the project team, and make the necessary decisions and actions to solve any study related matter under his/her responsibility
Supervise recruitment and motivate investigating centers (follow-up, newsletters, information on study progress, etc.). Ensure that they have and maintain adequate equipment, materials and personnel to conduct the trial
Conduct micro-planning follow-up in order to ensure that the committed targets (# active sites, # patients enrolled) are met in the committed administrative timelines, for the respective allocated clinical trials & Corporate Clinical Teams
Monitor patient safety and drug tolerability by documenting adverse events
Control the quality of data collected, technical validation of CRFs.
Comply with the deadlines fixed by Data Management
Ensure data cleaning and data base locks
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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