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. We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That's why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them. 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. Duties/Responsibilities + 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 Qualifications Do you have the following skills, experience and knowledge? + BS degree or equivalent, related experience required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) + Demonstrated ability 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) + Understanding of ICH and GCP guidelines + Knowledge of systems/technology (e.g. IWRS, EDC, etc.) + Excellent organization and time management skills, attention to detail, and ability to multi-task in environment with shifting priorities + 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job funct