Manager Unmasked Drug Oversight

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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 & 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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