The Clinical Project Leader is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project. The CPL 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.
As a Clinical Project Leader your main responsibilities will be:
- 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.
- 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.
- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- Fluency in English & Italian
- Previous experience in managing clinical trials in pharmaceutical or CRO industries
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
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