J&J Drug Monitoring Manager Vacancy – Apply Online
J&J Drug Monitoring Manager. Biology and Life Science Job. Johnson & Johnson is a leading company with numerous job openings for Biology candidates. J&J is currently hiring for an Independent Drug Monitoring Manager job. Biology job opening 2020. Check out all the details on the same below:
Job Title: Independent Drug Monitoring Manager
Location: United States-Pennsylvania-Malvern-
Qualifications for J&J Drug Monitoring Manager
- 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.
- J&J Drug Monitoring Manager 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 an environment with shifting priorities is required
- Must demonstrate the innovative spirit and strong interpersonal and leadership skills
Duties/Responsibilities
- Leading study 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).
- J&J Drug Monitoring Manager Conducting IDM team meetings to discuss the 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 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 a 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.
- J&J Drug Monitoring Manager 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
