Johnson & Johnson is recruiting for a Manager, Clinical Trial Management Solutions located in Raritan, NJ, Titusville, NJ, Spring House, PA, Horsham, PA and Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.
The Manager, Clinical Trial Management Solutions supports systems that track activities such as trial design, site selection, contracts and grants, Clinical Trial Management Systems (CTMS), trial Metadata, Randomization and Trial Supply Management (RTSM), study specific capabilities (e.g. portals) pre-approval patient access and operational data validation, enrollment forecasting and tracking, optimal system usage, and continuous improvement. The Manager support the successful setup and oversight of studies in CTMS across Therapeutic Area(s), adherence to timelines, and compliance with all CTMS Standard Operating Procedures (SOPs), policies and regulatory requirements. Responsibilities include:
- Work closely with Clinical Trial Management Business Support (CTM BS) Experts on study build in Medidata CTMS and Grants Manager including, but not limited to business configuration, change management, templates, helpdesk metrics review, user/site administration service, alignment Master Data Management (MDM)/Drug Development Information Governance (DDIG) for Master Data.
- Work with Process Owners and Functional Management on consistency and demonstrate leadership in cross-functional inspection readiness of CTMS related inspections and inquiries.
- Support the close alignment with business owners, as well as continuous improvement creating and leveraging system capabilities in support of business processes.
- Work with Decision View Study Optimizer (DVSO) Business Lead and a network of Subject Matter Experts (SMEs) within the different organizations, such as Portfolio Delivery Operations (PDO), Global Clinical Operations (GCO), Clinical Supply Chain (CSC) and Project Management Organization (PMO) to integrate process for use of DVSO in current process.
- Interact with other functions and internal/external business partners as required.
- Lead the establishment of comprehensive processes that ensure quality and completeness of the supported systems.
- Support the management of relationships with key stakeholders, including system owner, (Medidata) helpdesk manager, Business Unit Information Technology (BUIT), Data Standards, Trial Master File (TMF) capability head, TMF system owner, and Contracts and Grants management.
- Support the study build processes and related integrations to RAVE (EDC System Vendor), Grants Manager and TMF for successful start-up and execution of clinical trials.
- Support for monitoring and managing overall performance of process to drive quality and compliance across the organization. Ensure that all operational objectives are met in conformance to all relevant regulations, guidelines and internal SOPs, Work Instructions (WIs) and Instructions for Use (IFUs).
- For assigned projects management and oversight of budgets and timelines.
- Lead small and large projects as assigned.
- Support the Champion community.
- Participate/Lead in migration projects
- A minimum of a Bachelor’s degree or equivalent is required, preferably in Health, Science or Information Technology. Advanced degree (e.g. Master’s, MBA, MD, PhD) preferred.
- A minimum of 8 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required.
- Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Proficiency with CTMS, TMF and/or other clinical trial management systems and processes is preferred.
- Proficiency in English (reading, writing, speaking) is required.
- Must have excellent communication skills is required.
- Must have strong problem solving and prioritization skills is required.
- The ability to partner with all levels of management and influence decision-making across a matrix organization is required.
- The ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment is required.
- Project Management Certification is preferred
Ability to travel up to 10% of time domestic and international is required
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 States-New Jersey-Raritan-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)