Analyst II, Clinical Data Manager

basis with the DML and the amount of instruction is limited.

Principal Responsibilities:

• Take on a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:

  • Gather and/or review content and integration requirements for Electronic Code of Federal Regulations (eCFR) and other data collection tools.

  • Establish conventions and quality expectations for clinical data.

  • Establish expectations for dataset content and structure.

  • Set timelines and follow-up regularly to monitor delivery of all data management milestones.

• Review clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.  Ensure compliance with regulatory guidelines and the documentation matrix.

• Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and Johnson & Johnson internal audits as necessary.

• Plan and track content, format, quality, and timing of applicable data management deliverables.  Ensure deliverables are on time.

• Take a leadership role with the assigned clinical working group(s) to ensure that DM and Therapeutic Area (TA) trial needs and deliverables are achieved.

• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.

• Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.

• Identify and participate in process, system, and tool improvement initiatives.

• Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS), and Study Responsible Physician (SRP) related queries in Electronic Data Capture (EDC) system.  Involvement in other clinical data review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation) is possible.

• Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.

Qualifications:

• A minimum of a Bachelor's degree is required, preferably in Clinical Data Management, Life Sciences or Computer Sciences.  Advanced degree (Master’s, PharmD, PhD) preferred.

• A minimum of 2 years of experience in the Pharmaceutical industry, Contract Research Organization (CRO), or related industry is required.

• Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols is preferred.

• Experience in clinical drug development within the Pharmaceutical industry or related industry is required.

• Knowledge of current clinical drug development processes is preferred.

• Knowledge of applicable international guidelines regarding data management of clinical trials is preferred.

• Knowledge of technology platforms and systems to capture and process data (e.g., Medidata Rave, Inform) is preferred.

• Understanding of data privacy rules in relation to clinical data exchange is preferred.

• Experience in the Oncology Therapeutic Area is preferred.

• Team leadership experience is preferred.

• Project management experience is preferred.

• Experience working with cross-functional stakeholders and teams is required.

• Must have excellent verbal and written communication skills.

• Must have the ability to adapt to a rapidly changing organization and business environment.

• The ability to collaborate with all levels of management across a matrix environment is required.

• This position will require up to 10% travel.

The anticipated base pay range for this position in all other U.S. locations is $92,000 to $148,350. 

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.

• 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)).

• This position is eligible to participate in the Company’s long-term incentive program.

• 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

• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on July 14, 2026.  The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Advanced Analytics, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Communication, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Organizing, Problem Solving, Report Writing, Standard Operating Procedure (SOP), Systems Analysis