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 athttps://www.jnj.comJob Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom 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 athttps://www.jnj.com/innovative-medicineWe are searching for the best talent for a Lead, Trial Delivery Manager to be in High Wycombe, United Kingdom. Remote work options may be considered on a case-by-case basis and if approved by the Company. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-008268 Belgium, Netherlands, Poland, Spain - Requisition Number: R-009303 Switzerland - Requisition Number: R-009308 United Kingdom - Requisition Number: R-009311 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Lead, Trial Delivery Manager (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery. You will be responsible for: • Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation). • Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight. • Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries). • Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing. • Provide input into trial level operational strategies. • Resolve trial-related issues and mitigate trial-related risks. • Participate in process improvement activities at a trial, compound & cross-DU level, as needed. • Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues. • Mentor & support onboarding of new team members, particularly those in Trial Management. Qualifications / Requirements: Education: • BS degree required, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Required: • Minimum of 4 years clinical trial experience in Pharmaceutical or Healthcare • Minimum of 2-3 years’ experience supporting multiple aspects of a global clinical trial • Clinical research operational knowledge and experience across multiple phases of studies • Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness • Experience leading without authority and in multi-functional matrixed and global environments • Excellent decision-making, analytical and strong financial & vendor management skills • Operate and execute with limited supervision • Strong project planning/management, communication and presentation skills • Travel up to 10% of the time, defined by business needs. Preferred: • Experience managing multiple countries • End to end vendor management
