Lead, Clinical Data Management - MedTech

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Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Clinical Data Management

Job Category:
Professional

All Job Posting Locations:
Albany, New York, United States of America, Albany, New York, United States of America, Baltimore, Maryland, United States, Bangor, Maine, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Concord, New Hampshire, United States, Dover, Delaware, United States, Hartford, Connecticut, United States, Newark, New Jersey, United States, New Brunswick, New Jersey, United States of America, New Haven, Connecticut, United States, New York, New York, United States, Norfolk, Virginia, United States, Philadelphia, Pennsylvania, United States, Pittsburgh, Pennsylvania, United States of America, Portland, Maine, United States, Providence, Rhode Island, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Richmond, Virginia, United States of America, Springfield, Massachusetts, United States, Stamford, Connecticut, United States, Syracuse, New York, United States, Trenton, New Jersey, United States of America {+ 1 more}

Job Description:

We are searching for the best talent for a Lead, Clinical Data Management to support our MedTech Business.

This is a remote role available in multiple states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following states where this opportunity is available:

Maryland, Delaware, Virginia, New Jersey, Pennsylvania, New York, Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, & Maine.

Purpose: The Lead Clinical Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.

You will be responsible for:

Reporting to the Manager, Clinical Data Management this individual will:

• Mentor, train and supervise junior associates as needed in clinical data management processes and procedures.
• Independently lead several complex trials.
• Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required.
• Be responsible for creation of data management plans and other data management documentation as needed.
• Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM (Biostatistics, Statistical Programming & Data Management) functions.
• 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.
• Proactively organize and manages ongoing data review throughout study conduct, 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 of data handling processes for non-CRF data, including lab data and image handling.
• Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets.
• Lead efforts co-ordinating with Medical Affairs organization 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.
• 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.
• Perform other related duties as required.

Qualifications / Requirements:

• Minimum of a Bachelor's degree (or equivalent) in biological sciences, Computer Science or related discipline required; Advanced Degree strongly preferred.
• At least 6+ years of clinical data management experience in Medical Device or Pharmaceuticals including experience of successful active participation in cross-functional teams required. (4+ with Advanced Degree).
• Familiarity with at least one programming language such as SAS, or R highly preferred.
• Experience with Electronic Data Capture (EDC), Medidata RAVE required.
• Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc).
• Excellent verbal and written communication skills.
• Knowledge of Google Cloud Platform and regulatory requirements regarding clinical data management documentation and software.
• Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).

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, please contact us via or contact AskGS to be directed to your accommodation resource.

#LI-Remote

The anticipated base pay range for this position is :
The base pay range for this position is $105,000 to $169,050.

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.