Clinical Data Manager

Company Overview At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Details Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: We are searching for the best talent for our Manager, Clinical Data Management position to be located in Spring House, PA; Horsham, PA; Raritan, NJ; or Titusville, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Manager, Clinical Data Management works under minimal supervision and may lead portions of a program, project and/or process and provide training and guidance to staff. In this role, the Manager, Clinical Data Management provides direct subject matter expertise to establish operational plans and implement products, processes and standards that have some impact on business results. This position applies in depth knowledge and experience to address complex problems that require an understanding of one or multiple related disciplines. This position reports to Data Acquisition Functional Leadership and represents Data Management in cross functional discussions, with the ability to influence key stakeholders and contribute to strategic discussions and decisions. This position may also participate in continuous improvement initiatives and industry work groups. This position develops strong and productive working relationships with key stakeholders within IDAR and Global Development, in addition to broader partners, external suppliers and/or industry groups. Responsibilities Planning, executi, and completion of all data acquisition activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency. Ensuring timely and effective maintenance of functional planning systems. Independently and effectively managing issue escalations, adopting appropriate escalation pathways. Anticipation, early detection, prevention and management of risks and issues impacting deliverables and activities. Leading or contributing to the development and maintenance of departmental policies, procedures, training, and standards. Contributing to the development of functional vendor contracts and oversee of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates. Contributing to the enhancement of functional, technical and/or scientific capabilities within data management. Influencing the external industry and/or regulatory environment through active engagement in industry forums and working groups. Supporting data acquisition related aspects of regulatory agency inspections and internal audits. Ensure real time inspection readiness for all data acquisition deliverables. Qualifications / Requirements Bachelor's degree (e.g., BS, BA) is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD). A minimum of 6 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry is required. In-depth knowledge of data management practices (including tools and processes) is required. In-depth knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., HL7 FHIR) is required. Advanced project and risk management skills with an established track record delivering successful outcomes is required. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors is required. Excellent communication, leadership, influencing and decision-making skills is required. Excellent written and verbal communications skills is required. Innovative thinking to allow for optimal design and execution of clinical development strategies is preferred. Development and implementation of a business change/innovative way of working is preferred. Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms is preferred. Equal Opportunity Employer 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 & 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, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check. Required and Preferred Skills Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Innovation, Leverages Information, Process Improvements, Regulatory Affairs Management, Research Ethics, Technical Credibility Compensation and Benefits The anticipated base pay range for this position is : $117,000.00 - $201,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year for employees who reside in the State of Colorado –48 hours per calendar year for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information #J-18808-Ljbffr