Manager Unmasked Drug Oversight

Description

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 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.

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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

Johnson & Johnson is currently seeking a Manager Unmasked Drug Oversight to join our team located in Beerse - Belgium, Milan - Italy, Leiden - The Netherlands, or Madrid - Spain.

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

In this role you will be 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. You will work 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.

Principal Responsibilities:

• 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.

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

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

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

• Ensure compliance with internal operating procedures and processes.

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

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

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

• 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.

• 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.
  

Education and Experience Requirements:

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

• 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)

• 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 multitask 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.

• ▪ Global experience is required

• 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%

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