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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 https://www.jnj.com

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

We are searching for the best talent for a Manager, Unmasked Drug Oversight to be located in Spring House, PA or Titusville, NJ.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: The Manager Unmasked Drug Oversight (UDO) sits within the Unmasked Drug Monitoring Management department (UDMM).

The Manager Unmasked Drug Oversight (UDO) is responsible for the study and country level management of clinical operation activities related to Investigational Product (IP) management for inhouse and outsourced, blinded studies that have an unblinded IP component.

The Manager Unmasked Drug Oversight (UDO) works closely with the Central and Local study teams, Data Management, Trial Supply and other Global Development functions during planning, study start up, execution and study closure.

Responsibilities include creating of and/or, contributing to development of study procedural documents and system development, overseeing and supporting the Independent Drug Monitor (IDM) with site level activities with regards to pharmacy staff training, IP management, IP/dosing- related issues, unblinded Protocol Deviation (PD) escalation and resolutions, and monitoring pharmacy compliance with the protocol and study procedures.

You will be responsible for:

• Lead study teams and UDMM teams in management of the Unmasked Drug Monitoring Management process; including input to and the development of pharmacy related materials (e.g., forms and manuals) and system set-up and maintenance (e.g., RTSM System and EDC).

• Lead and conduct IDM team meetings (IDMT), Unmasked country calls, PD & Issue review meetings, internal study specific UDO team meetings to plan and discuss study timeline, key milestones, expected deliverables, IDM metrics and provide study specific (re)training, if applicable.

• Oversee the IDM activities and ensure investigational product issues are addressed at sites.

• Monitor the pharmacy compliance by reviewing system reports, study-specific trackers, and other tools, as needed. Provide pharmacy compliance status, trends, and risks to the study team with actions taken.

• Investigate urgent/critical unblinded and pharmacy-related issues and coordinate resolutions. Escalate to study team in blinded fashion and ensure pharmacy related issues and Protocol Deviations (PDs) are resolved and documented.

• Review and approve IDM monitoring visit reports (initiation, routine, non-routine, off-site and closure) and provide feedback, as necessary.

• Ensure the creation, collection and filing of the study essential documents are completed as per established timelines and/or governing SOPs.

• Act as the main point of contact for resolution of any questions associated with IP and IDM issues.

• 9 Support the pharmacy/Investigational Product (IP) related inspection readiness activities and provide inputs and follow up on audit CAPAs.

• 10 Coordinate data cleaning, in collaboration with the trial team, to facilitate timely and successful interim analyses and database locks.

• 11 Assist in Database Locks (DBL) and reviewing unblinded queries, as needed.

• 12 Ensure compliance with internal operating procedures and processes.

• 13 Participate in preparation for, and conduct of, Health Authority inspections and internal audits

• 14 Generate metrics, to ensure quality and compliance oversight over unblinded activities and to ensure inspection readiness.

• 15 Monitor key risk indicators, escalate, and mitigate as required.

• 16 Actively drive accountability, improvement, solutions and mitigations with the relevant team members/functions.

• Demonstrate operational excellence by utilizing data, metrics, and reports to track and manage performance, quality, and compliance, as per the UDMM Key Performance Indicators.

• Evaluate new and revised processes and systems for your role and implement as required.

• May contribute to process improvement activities, taskforces and provide innovative input.

• Participate in/lead projects, task forces and/or initiatives in support of the business, efficiencies, process improvements, or process development and provide innovative input.

• Might be involved in invoice review/approval, as per local process requirements

• Support, mentor, train more junior level staff.

This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.

Decision-Making and Problem-Solving

• Must demonstrate the ability to solve complex issues. Take initiative to suggest and implement solutions for study, country, and site-level issues. Critically examine situations to ensure issues are reported and escalated, as necessary.

Qualifications / Requirements:

Education:

• Minimum BS degree preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy, or related scientific fields) is required.

Experience/Skills:

• Minimum of 8 years of experience in clinical trial operations, pharmacy industry or CRO

• Experience with clinical trial related activities at the site pharmacy (e.g. temperature monitoring, drug accountability, pharmacy monitoring)

• Global experience is required.

• Proven track record in successfully managing various aspects of trials from start-up to database lock.

• Solid communication and computer skills required.

• Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel in different disease areas, if required.

• Deep understanding of ICH and GCP guidelines.

• Ability to lead cross-functional team in matrix environment.

• Knowledge of systems/technology (e.g. RTSM system EDC, etc.) is required.

• Strong leadership, communication, and proven ability to solve complex problems.

• Excellent organization and time management skills, attention to detail, and ability to multi-task in environment with shifting priorities

• Strong project management skills

• Must demonstrate innovative spirit and strong interpersonal and leadership skills.

• Strong knowledge of standard Microsoft applications, willingness to learn new systems.

• Level of Autonomy: Requires limited level of supervision.

• Can coach and mentor junior staff, as needed.

• Demonstrates Organizational awareness.

• Experience with unmasked drug oversight is preferred

• Participate in Global Development Initiatives, as assigned

• Proficient in speaking and writing in English

• Can act as a Subject Matter Expert

• Can act as Coordinator Unmasked Drug Oversight in complex trials with multiple UDMM representatives, as assigned.

• Local and International Travel 10%

The anticipated base pay range for this position in the US is $115,000 to $197,800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

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

This job posting is anticipated to close on May 7, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$115,000 to $197,800

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.