Project Manager

at  Thermo Fisher Scientific

NIS STUDY DELIVERY LEAD

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

• Planning and leading the delivery of NIS to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
• Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
• Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms / tools etc).
• With the majority of NIS fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH / GCP & ENCePP guidelines and/or applicable guidelines for studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk / benefit with clear understanding of the impact on the study and project; acts to mitigate risk where appropriate.
• Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.
• Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills