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 handled, 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.

**Position Overview**:
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.

**Key Responsibilities**:

- 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 deliverables, and provide study specific (re)training, if applicable.
- Oversee the IDM monitoring activities, review IDM monitoring visit reports 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. Raise to study team in blinded fashion and ensure pharmacy related issues and Protocol Deviations (PDs) are resolved and documented.
- Ensure the collection and filing of crucial study documents are completed as per established timelines and/or governing SOPs.
- Act as the main point of contact for resolution of any ad-hoc 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.
- Assisting in Database Locks (DBL) and reviewing unblinded queries, as needed.
- Adhere to the applicable SOPs, global regulations, ethics and departmental compliance as determined by GCO management as well as corporate, HCC, and quality guidelines

**Qualifications**
- Minimum of a BS degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 3 years of clinical operations experience in the pharmaceutical industry, CRO or equivalent
- Preferred is 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)
- 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

**What we’re about**:
We are passionate about our work and play vital roles across a range of professional disciplines. We care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers We share a kind of DNA where we’re each:

- Committed to caring
- Responsible to our communities
- Unique in our background and experiences
- The drivers of our own success
- Passionate about doing what’s right
- **Make a unique mark in your career**

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