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.