Beerse, BEL
12 days ago
Senior Local Trial Manager
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job Category:** Professional **All Job Posting Locations:** Beerse, Antwerp, Belgium **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are looking for a driven **Local Trial Manager** (LTM) to report to the Manager Clinical Operations (MCO), running assigned clinical trials (phases 1b-2-3) in the Netherlands and in Belgium. You will have operational oversight of assigned protocols from start-up through to database lock/ closure of the trial. You will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards. The LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA) and Site Managers (SM) roles. The LTM may have some site management responsibilities. You need a flexible mindset and have the ability to work in a fast-changing environment. You will be part of a hardworking, enthusiastic, and committed team of +100 people eager to deliver and helping to improve the lives of millions of patients. **Principal Responsibilities:** Collaborate with the MCO for feasibility assessment. Set predictable and realistic start up time lines. Lead and coordinate trial activities and project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Act as subject matter expert for assigned protocols. Develop strong therapeutic knowledge to support roles and responsibilities. Act as primary country contact for a trial. Establishes and maintains excellent working relationships with external organisations and internal partners, including Medical Affairs. Encourage and empower trial teams to deliver on the trial commitments. Keep patient engagement and safety central to all activities. Contribute and encourage process improvement at every opportunity. **Do you have the following Education and Experience we require?:** + A minimum of a BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required. + You have gained experience in clinical trials and preferably in site monitoring and have experience of project management tasks. + Ability to travel with occasional overnight stay away from home. + Drivers license B required. + You have proven leadership, communication and digital literacy. + The ability to lead initiatives/small teams. + Proficient in Dutch and English
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