Independent Drug Monitoring Manager
Employment Type: Full-Time
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Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Independent Drug Monitoring Manager in USA East Coast (Malvern, PA; Spring House, PA; Raritan, NJ; Titusville; Beerse, Belgium; High Wycombe, UK; Leiden/Breda, The Netherlands; Allschwil, Switzerland; Warsaw, Poland; APAC core countries (Taiwan, Malaysia, China, South Korea); and other countries.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.
As an IDMM you are responsible for the country level and global management of clinical operations activities related to Investigation Product (IP) management for inhouse and outsourced, blinded studies. The IDMM works closely with the Global Trial Manager (GTL), Clinical Trial Manager (CTM), Global Data Manager (GDM), Trial Supply Manager (TSM) and other Global Development functions during planning, study start up, execution and study closure. Responsibilities include creating & contributing to development of study procedural documents and system development, oversight for IDM activities with regards to site 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.
- Leading study teams in management of the Independent Drug Monitoring process; including input to and the development of pharmacy related materials (e.g., forms and manuals) and system set-up and maintenance (e.g., IVRS and EDC).
- Conducting IDM team meetings to discuss study timeline, expected deliverables, and provide study specific (re)training, if applicable.
- Coordinating the IDM monitoring activities and ensure investigational product issues are addressed at sites.
- Monitoring the pharmacy compliance by reviewing system reports, study-specific trackers, and other tools, as needed. Provide pharmacy compliance status, trends, and risks (when identified) to the study team with actions taken.
- Investigating urgent/critical unblinded and pharmacy-related issues and coordinate resolutions. Raise to study team in blinded fashion and ensure pharmacy related issues and Protocol Deviations (PDs) are resolved and documented.
- Reviewing IDM monitoring visit reports (initiation, routine, non-routine, off-site. and closure) and provide input, as necessary.
- Ensuring the collection and filing of crucial study documents are completed as per established timelines and/or governing SOPs.
- Acting as the main point of contact for resolution of any ad-hoc questions associated with IP and IDM issues.
- Supporting the pharmacy/Investigational Product (IP) related inspection readiness activities and provide inputs and follow up on audit CAPAs.
- Assisting in Database Locks (DBL) and reviewing unblinded queries, as needed.
- Working according to the applicable SOPs, global regulations, ethics and departmental compliance as determined by GCO management as well as corporate, HCC, and quality guidelines
- BS degree OR equivalent OR related experience required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Preferred experience in clinical trial operations within Pharma/CRO.
- Experience with clinical trial related activities at the site pharmacy (e.g. temperature monitoring, drug accountability, pharmacy monitoring) is preferred.
- Understanding of ICH and GCP guidelines is required.
- Knowledge of systems/technology (e.g. IWRS, EDC, etc.) is required
- Excellent organization and time management skills, attention to detail, and ability to multi-task in environment with shifting priorities is required
- Must demonstrate innovative spirit and strong interpersonal and leadership skills
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Malvern-Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Allschwil, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Asia Pacific-Malaysia, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, Asia Pacific, Asia Pacific-Taiwan, Asia Pacific-South Korea, Asia Pacific-ChinaOrganization
Janssen Research & Development, LLC (6084)Job Function
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