Overview
THE JOB - Clinical Team Lead is 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 coordinates and manages 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.
Master in Science. Good level of English.
Responsibilities
* 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.
* 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.
About 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.
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