Job Overview :
We are hiring Clinical Team Lead to insoruce to our client for project management.
Collaborate, when applicable, with the Medical Advisors during the feasibility study process.
Ensure the fulfilment of objectives defined in the protocol (number of patients and centres, timelines, budget).
Ensure the ICH-GCP, corporate & local SOPs, and local regulations are respected and followed by all parties.
Prepare Clinical AED.
Participate in the submission of the project to the Ethics Committees and Health Authorities.
Validate the translation and adaptation of required documentation (protocol, informed consent form...), together with the Medical Advisors.
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.
Finalize financial agreements (negotiation with the investigator, hospital, university, pharmacy, contractors, etc.).
Participate in the validation of Case report Forms (CRFs) when applicable
Select potential investigating centres 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.
Identify any specific problem related to the study, and propose possible solutions in agreement with Lead CPL..
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 centres (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, together with the GPE (Global Pharmacology and Epidemiology)
Control the quality of data collected, technical validation of CRFs.
Comply with the deadlines fixed by Data Management
Handle issues specifically related to the study : critical events, patient narratives, Clinical Study Report.
Administrative and Financial Management of the Clinical Trial.
Participate in the closing activities and organize archiving (together with local monitoring teams : CRAs / CPAs).
Participate in corporative and external Quality Audits and Inspections, coordinate the responses and ensure the follow-ups of corrective measures when necessary.
Ensure the good management of IP, together with the IP Manager.
Inform the CRU Director of the study progress and the difficulties encountered; reviews with him / her the strategy to implement.
Ensure that International Clinical Development (Clinical Investigations and Clinical Operations) have all necessary information on study progression.
Participate in study-related meetings organized by International Clinical Development.
Maintain professional expertise by attending lectures and conferences.
Contribute to information and training of local monitoring teams.
Education / Qualifications :
Degree in medicine or Health sciences. Background in GCP& ICH, local & Corporate SOPs, and clinical research.
More than 1 year project management experience
More than 5 years of clinical research experience
Preferred oncology experience