At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Data Analytics & Computational Sciences **Job Sub** **Function:** Clinical Data Management **Job Category:** Professional **All Job Posting Locations:** Somerville, New Jersey, United States of America **Job Description:** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **OVERALL RESPONSIBILITIES:** The Manager, Data management, will be responsible for oversight and management of all aspects of clinical data management associated with 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 Director, Data Management and Clinical Systems, this individual will; + Ensure efficient use of resources across the franchise to provide high quality clinical data, on time, within budget by monitoring progress and conduct of their teams respective projects. This includes all data cleaning and QC activities and partnering as appropriate with Clinical Operations, Franchise and other BSDM functions; + Provide leadership, direction and mentoring for their respective 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; + Be responsible for approval of data management plans and other respective data management documentation as needed; + Lead, coordinate, facilitate and manage 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 trial execution including timelines, milestones, budgets. Will also ensure their team organizes and manages ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project; + Proactively identify and address issues that may impact the quality of the data, deliverables or timelines; + Be responsible for Identification and management of data handling processes for non-CRF data, including lab and image handling; + Lead efforts co-ordinating with Medical Affairs organization as needed to facilitate data coding and safety reviews as needed; + Independently lead new data management initiatives and contribute towards 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) as needed to ensure effective processes and communications; + Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, 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, gynecology, cardiovascular, 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 stakeholders and external experts 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. **EDUCATION & EXPERIENCE REQUIREMENTS:** + A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline (required), + Minimum of 8 years of clinical data management experience in Medical Device or Pharmaceuticals and at least 1 year of supervisory experience. + Experience with R or SAS programming is preferred Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. **The anticipated base pay range for this position is :** $115,000- $197,000 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.