Lead, Trial Delivery Management

Biopharma Careers; North Carolina; On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

401(k) plan

Pension scheme

Paid time off

Job summary

Johnson & Johnson is seeking a Lead, Trial Delivery Management to oversee study-level activities, create and update trial documents, manage vendors, and ensure country/regional delivery aligns with feasibility strategies. You will mentor new team members and influence program-level operational planning.

Required are 4+ years in clinical trials, multi-country experience, and strong leadership with excellent communication and budgeting capabilities.

Qualifications

• BS degree or equivalent, Life Sciences preferred.
• Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
• Clinical research operational knowledge across multiple phases (Phase I-IV) with ability to manage multiple aspects of trial execution.
• 2-3 years’ experience supporting multiple aspects of a global clinical trial.
• Must possess leadership skills and ability to foster team productivity in global matrixed environments.
• Excellent decision-making, analytical and financial management skills.

Responsibilities

• Create and update trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product documentation).
• Manage vendor setup and day-to-day vendor activities (SOW creation, budget oversight).
• Coordinate country/region trial management activities; align feasibility strategy with local teams and perform country-level risk reviews.
• Support development of program-level compound training with Clinical/CTL&D/Medical writing.
• Provide input into trial-level operational strategies.
• Resolve trial-related issues and mitigate trial risks.
• Participate in process improvement activities at trial, compound and cross-DU levels.
• Provide support during Health Authority inspections and identify risk mitigations at the program level.

Skills

Clinical trial management

Leadership

Budget oversight

Cross-functional collaboration

Project planning

Decision making

Communication

Education

BS degree in Life Sciences

Tools

CTMS

Regulatory compliance

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Operations

Job Sub Function

Clinical Trial Project Management

Job Category

Professional

All Job Posting Locations

Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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

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):

High Wycombe, United Kingdom - Requisition Number: R-096653

Spring House, PA, Titusville, NJ United States - Requisition Number: R-098245 Beerse,Belgium,Breda,Netherlands, Warsaw,Poland, Madrid,Spain, Milan,Italy - Requisition Number: R-098254

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Lead, 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 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.

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)
• Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
• 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.
• Travel up to 15-20% of the time, defined by business needs.
• Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology

Required Skills

Preferred 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)

Preferred Related Industry Experience

Pharmaceutical, Biopharmaceutical, Biotechnology

Additional Description for Pay Transparency

The anticipated base pay range for this position is : $109,000.00 - $174,800.00

• 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

Please use the following language:

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits