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.
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
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)
Minimum of 6 years clinical operations experience
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
Ready to apply our knowledge and know-how
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!
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
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 Kingdom-England-High Wycombe- Other Locations
North America-United States-Pennsylvania, United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-United Kingdom, North America-United States-Florida, North America-United States-New Jersey Organization
Janssen Cilag Ltd. (7360) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies