Biotech and Agricultural Creative and Design Medical and Healthcare
1 - 2 Years
SR INDEPENDENT DRUG MONITORING MANAGER
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
The Senior Independent Drug Monitoring Manager (Sr. IDMM) is responsible for the country level/global management of clinical operation activities related to Investigational Product (IP) management for inhouse and outsourced, blinded studies. The Sr. IDMM works closely with the Global Trial Leader (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 crafting, contributing to the development of study procedural documents and system development, supervising the 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.
Lead study and IDMM teams in the 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).
Conduct IDM team meetings to discuss study timeline, expected results, and provide study specific (re)training, if applicable.
Lead all aspects of the IDM monitoring 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 (when identified) to the study team with actions taken.
Investigate urgent/critical unblinded and pharmacy-related issues and coordinate resolutions. Bring up 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 feedback, as necessary.
Ensuring the collection and filing of the study essential 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.
Adhering to applicable SOPs, global regulations, ethics and departmental compliance as determined by GCO management as well as corporate, HCC, and quality guidelines.
Participating in/leading projects and initiatives in support of the business, efficiencies, process improvements, or process development.
Support, mentor, train more junior level staff.
Education and Experience Requirements!
BS degree or equivalent, related experience required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Proven ability in clinical trial operations
Experience with clinical trial related activities at the site pharmacy (e.g. temperature monitoring, drug accountability, pharmacy monitoring)
Deep understanding of ICH and GCP guidelines
Ability to lead cross-functional team in matrix environment Knowledge of systems/technology (e.g. IWRS, EDC, etc.) is required
Strong leadership, communication, and proven track record to solve complex problems.
Excellent organization and time management skills, attention to detail, and ability to multi-task in environment with shifting priorities
Proficient in Microsoft applications (Excel, PowerPoint, etc.)
Must demonstrate innovative spirit and strong interpersonal and leadership skills!
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
United Kingdom-England-High Wycombe- Other Locations
Netherlands, Switzerland, Poland, Belgium, United States-Connecticut, United States-Delaware, United States-Florida, United States-Georgia, United States-Massachusetts, United States-Maryland, United States-Maine, United States-North Carolina, United States-New Hampshire, United States-New Jersey, United States-New York, United States-Rhode Island, United States-South Carolina, United States-Virginia Organization
Janssen Pharmaceutica N.V. (7555) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies