Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D OperationsJob Sub Function:
Clinical Trial Project ManagementJob Category:
ProfessionalAll Job Posting Locations:
High Wycombe, Buckinghamshire, United KingdomJob Description:
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 searching for the best talent for Manager, Trial Delivery Management (TDM) to be located in one of the following locations (Hybrid). (Remote working will be considered on a case by case basis and with approval of the business).
- High Wycombe / Maidenhead, United Kingdom
- Beerse, Belgium
- Breda, Netherlands
- Madrid, Spain
- Spring House/ Titusville / Raritan / Horsham, United States
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 Kingdom- Requisition Number: R-086693
Belgium, Spain, Netherlands- Requisition Number: R-094113
United States- Requisition Number: R-094118
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Position Summary:
The Manager, Trial Delivery Management (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 Manager 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:
- Creating and updating critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
- 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).
- Supporting development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.
- Providing input into trial level operational strategies.
- Resolve trial-related issues and mitigate trial-related risks.
- Participating in process improvement activities at a trial, compound & cross-DU level, as needed.
- Providing support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
- Mentoring & supporting onboarding of new team members, particularly those in Trial Management.
- Fostering employee engagement, inclusion, and Credo Behaviors.
Principal Relationships:
Internal: Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams, representatives of Procurement
Are you ready to join our team? Then please read further!
Education and Experience Requirements:
- BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology,
- Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 8 years in Pharmaceutical, Healthcare or related industries!
- Experience in and knowledge of the pharmaceutical development process.
- Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
- 2-3 years’ experience leading multiple aspects of a global clinical trial
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience of leading without authority and in muti-functional matrixed and global environments.
- Excellent decision-making, analytical and strong financial management skills are essential to this position.
- Operate and execute with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management, communication and presentation skills are required.
Benefits:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#LI-Hybrid
Required Skills:
Mentor Coaching, Trial Management, Vendor ManagementPreferred Skills:
