Manager, Clinical Data Management

Company: Johnson & Johnson
Location: Raynham
Posted on: June 8, 2021

Job Description:

Depuy Synthes, part of the Johnson & Johnson Medical Device Companies is currently recruiting for a Manager, Clinical Data Management in Warsaw, IN. Remote opportunity is available for anyone within a commutable distance of a Johnson & Johnson Medical Device facility. DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. The Manager, Data management, will be responsible for oversight of all aspects of clinical data management. Leading a team responsible for limited data entry, cleaning and quality review process across the Medical Devices Sector. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Position duties & responsibilities: Reporting to the Associate Director, Data Management and Clinical Systems, this individual will; Ensure efficient use of resources across the franchise to provide high quality clinical data by supervising progress and conduct of their teams respective projects. This includes partnering with cross functional teams to ensure all data cleaning and quality control activities are completed on time and within budget. Provide leadership, direction and mentoring staff including staff personal development. Ensure all projects are adequately resourced to meet project deliverables and ensuring data management tasks remain on target to project timelines. Lead/approve CRF design, review and validation of the clinical database, including management of CRO activities in this area if required. Responsible for approval of data management plans and other respective data management documentation as needed. Coordinate all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects. Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for study execution including timelines, milestones, budgets. Ensure their team prioritizes ongoing data review throughout the conduct of the study, including the correction of errors and discrepancy management for the life of a project. Proactively identify and address issues that may impact the quality of the data, deliverables or timelines. Lead initiatives for the identification and management of data handling processes for non-CRF data, including lab data and image handling. Lead efforts coordinating with Medical Affairs organization as needed to facilitate data coding and safety reviews as needed. Independently lead new data management initiatives and participate in process improvement, data standards and efficiency gaining initiatives within data management working with the project leader data standards to implement. Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner. Participate in vendor evaluation, selection, contracting, and oversight activities for Clinical Data Management. Work proactively with the clinical systems lead(s) to ensure effective processes and communications. Know and follow all laws and policies that apply to the job, and maintain the highest levels of integrity, ethics and compliance at all times. Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer. Performs other related duties as required. Functional and Technical Competencies: Therapeutic area knowledge in at least one of orthopedics, spine, trauma, or general surgery. History of leading project teams to deliver excellent quality results. Excellent verbal and written communication skills. Knowledge of GCP, CDASH/CDISC and regulatory requirements regarding clinical data management documentation and software. Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). Leadership Competencies: Connect - Develop strategic partnerships with key internal partners and external specialists to lead implementation of industry CDM standards. Shape - Develop knowledge of therapeutic areas within the Franchises and adapt CDISC standards for medical devices for use in the MD sector. Lead - build and develop talent through change to provide expert clinical data management capability. Deliver - ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs, seamlessly across all Franchises. Qualifications A Bachelor's degree (or equivalent) in the biological sciences, Computer Science or related discipline (required), with at least 8 years of clinical data management experience in Medical Device or Pharmaceuticals OR an Associates degree with 10 years of clinical data management experience in Medical Device or Pharmaceuticals is required. 1 year supervisory experience is required. RAVE & Veeva systems experience is preferred. Project Management experience 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. Primary Location United States-Massachusetts-Raynham-325 Paramount Drive Other Locations North America-United States Organization Medical Device Business Services, Inc (6029) Job Function R&D Requisition ID 2105930858W

Keywords: Johnson & Johnson, Brockton , Manager, Clinical Data Management, Other , Raynham, Massachusetts