Clinical Lead

4 settimane fa


Lombardia, Italia Confidenziale A tempo pieno

Importante Azienda PHARMA IS LOOKING FOR A CLINICAL LEAD FOR A PHARMACEUTICAL COMPANY, MILANO
What You'll Be Doing
Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
Drive the successful activation of trial sites according to time, quality/scope and budget parameters
Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones
Collaborate with Project Manager to establish clinical project timelines and accomplish all milestones throughout the study; understand and adhere to the contractual and budgetary obligations of the study
Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data and conduct of the study as dictated by applicable global regulations, Premier SOPs, ICH-GCP, protocol and client requirements
Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
Work with the Project Manager to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
Assist the project team in the creation and maintenance of the Trial Master File according to Premier Research and/or client SOPs and ensure all visit report packages are filed according to SOPs
Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
Actively participate in Bid Defense activities
You'll Need This To Be Considered
Bachelor's degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience along with 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring or 4 years remote monitoring experience is required); at least 2 years previous Clinical Oversight experience or equivalent (PM-CL)
Working knowledge of clinical financials including understanding of budgets, pass
- through and resource management
Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
Strong knowledge of web based communication tools, and MS Office computer skills
Fluent verbal and written English as well as the local language(s) required
Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team; Strong people management skills to motivate, enthuse, and lead
Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.
If this role is not quite right for you but you would like to have a conversation about other roles, do not hesitate to connect with me.



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