Lead, Trial Delivery Management

Lead, Trial Delivery Management (TDM)

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.

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 Operations

Job Sub Function: Clinical Trial Project Management

Job Category: Professional

All Job Posting Locations: Beershe, Antwerp, Belgium, Madrid, Spain, Milano, Italy, Warsaw, Masovian, Poland

Job 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.

Principal 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.

Education and Experience Requirements:

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Required Years of Related Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.

Required Knowledge and Experience:

• 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.
• 2-3 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.

Other:

Percentage Traveled: Travel up to 15-20% of the time, defined by business needs.

Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology

Required Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

The anticipated pay range for this position, in the primary posting location, is:

72,500.00 - 115,230.00

The anticipated pay ranges for additional locations are:

Spain The anticipated base pay range for this position is 55,400 EUR ? 87,860 EUR

Italy The anticipated base pay range for this position is 48,600 EUR 77,395 EUR

Poland The anticipated base pay range for this position is 210,000 PLZ ?402,500 PLZ

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.