Manager, Unmasked Drug Oversight

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