Project Manager Study-Start-Up

4 dni temu

Warsaw, Polska POL Fortrea Poland Sp z o.o. Pełny etat

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are is looking to hire a Project Manager Study-Start-Up (COM) in Poland . In this position, you will be fully dedicated to a single sponsor . This position is open for full-time candidates.
 

Your responsibilities:

Responsible for the execution and oversight of clinical trial country submissions and approvals for assigned protocols Development of local language materials including local language Informed Consents and translations Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Contributes to the development of local SOPs. Works in close collaboration internally with Clinical country operations, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable Financial duties including assistance with the ownership of country and site budgets Oversight and tracking of clinical research-related payments Payment reconciliation at study close-out Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical, regulatory, safety and finance systems.

Education, Skills and Other Requirements:

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 Previous experience in clinical research in pharmaceutical or CRO industries Previous experience in managing trials preferred Deep understanding of local regulatory environment Strong understanding of clinical trial planning, management and metrics is important as well as the ability to focus on multiple deliverables and protocols at a time Ability and skills to lead resource allocation, processes (and controls), productivity, quality and project delivery Strong organizational skills and time management skills Excellent interpersonal skills Proficiency in written and spoken English

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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