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Clinical Data Standards Lead
Requisition ID: 0566180504
The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Shared Services (CR&D) is recruiting for a Clinical Data Standards Lead located in West Chester, PA, Raynham, MA, Somerville, NJ, Irvine, CA, Warsaw, IN OR Cincinnati, Ohio.
The MD CR&D Shared Services is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies. The Shared Services organization is based on two functional teams: Operations and Biostatistics & Data Management. Both teams (along with their franchise partners) share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product life-cycle. Each team within CR&D Shared Services will have primary responsibility for defined areas of clinical program development, execution and dissemination.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Responsibilities include coordination of all clinical data standards including ownership of software to maintain the standards, development and validation of new standards. Provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms to ensure compliance with existing and planned standards. Coordination of activities will require the development of strong, productive relationships with colleagues across the MD sector. This individual performs with little to no supervision.
- Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards aligning to CDISC/CDASH standards (including eCRF structure, variables, formats, site numbering, edit checks, etc) across all franchises, partnering as appropriate with Clinical Operations;
- Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical data standards;
- Support the development and maintenance of global harmonized processes and procedures for implementation, use and maintainence of clinical data standards;
- Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems required to support clinical data standards; Assist with vendor evaluation and selection activities for clinical systems required to support clinical data standards;
- Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop and maintain clinical data standards including timelines and milestones for therapeutic area-specific standards;
- Lead project management activities related to the deployment and maintainence of clinical data standards;
- Create, review and facilitate approval of system deliverables and facilitate appropriate quality review where applicable;
- Mentor peers through review of deliverables to minimize delays during the quality review process;
- Train all stakeholders in the use established standards and associated processes
- Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools;
- Facilitate support requests associated with clinical systems (as needed);
- Serve as first line of contact from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs;
- Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes;
- Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed);
- Assist with the implementation of study metrics;
- Analyzes complex change requests to determine feasibility for incorporation within clinical studies;
- Evaluates vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters;
- Connect – Support strategic partnerships with Clinical System and IT leaders at the Enterprise level to ensure MD sector needs are communicated and understood, and with franchise and clinical operations leaders to ensure effective implementation and utilization of systems within the Clinical R&D Shared Services
- Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine STDM standards
- Lead – Mentor team mates to ensure consistency in process execution and quality system execution
- Deliver – ensure upgrades and maintenance of clinical systems are delivered on time, within budget and in compliance to regulations and SOPs, seamlessly across all Franchises
- A Bachelor’s degree in Statistics, Computer Science or related discipline, with a minimum of 6 years of system support in clinical research within Medical Device or Pharmaceuticals is required
- Strong proven experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required; Specific experience with EDC is preferred
- Previous experience in Clinical Operations is preferred
- Demonstrated ability to manage a project in a team environment to deliver critical milestones is required
- Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies is preferred
- Experience with CDISC STDM is required
- Proven experience in project management is preferred
- Knowledge of GCP and SDLC is required
- This position will be located in West Chester, PA, Raynham, MA, Somerville, NJ, Irvine, CA, Warsaw, IN or Cincinnati, OH and may require up to 10% travel
North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)
Clinical Data Management