Lead, Trial Delivery Management (1 of 3)
About The Position
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 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-057753 Japan - R-059626 United Kingdom - R-059552 Switzerland - R-059564 Belgium, France, Netherlands, Spain, Italy, Germany, Poland - Requisition Number: R-059569 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Remote work options may be considered on a case-by-case basis and if approved by the Company. We are searching for the best talent for Lead, Trial Delivery Management. 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.
Requirements
- Bachelor’s degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
- Minimum of 2 years’ experience supporting multiple aspects of a global clinical trial.
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience 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.
Nice To Haves
- Immunology clinical trial experience is preferred.
Responsibilities
- 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.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
