Senior Analyst, Clinical Data Management (2 Positions)

n 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://https://www.jnj.com

Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Clinical Data Management
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:

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 https://https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Analyst, Clinical Data Management (2 Positions). This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.

The Senior Analyst, Clinical Data Management is a professional individual contributor role at the experienced level that will provide oversight and accountability and/or execute data management activities and/or perform scientific data review for multiple low, moderate and high complexity trials. This individual will make recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML). This position will also make recommendations for processes, timing, structure and resources at a program level. The work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited. Work is reviewed with the DMLs or the immediate manager as needed.

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.

• Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.

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

• Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.

• Take a leadership role to obtain and share best practices with internal partners. Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.

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

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

• Lead others in implementing 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.

• Take a leadership role in collaborating 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 preferred (Master's, PhD).

• A minimum of 4 years of experience in the Pharmaceutical industry, Contract Research Organization (CRO), or related industry is required.

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

• Experience in clinical data review is required.

• Knowledge of medical terminology is required.

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

• Knowledge of current clinical drug development processes is required.

• 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 required.

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

• Knowledge of current industry standards (i.e., Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (STDM), Clinical Data Acquisition Standards Harmonization (CDASH), etc.) is required.

• Experience in the Oncology Therapeutic Area is preferred.

• Team leadership experience is required.

• 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 $105,000 to $169,050.

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)).

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

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://https://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.

This job posting is anticipated to close on April 2, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://https://www.careers.jnj.com to accept additional applications.

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.

#LI-Hybrid

The anticipated base pay range for this position is :
The anticipated base pay range for this position in all other U.S. locations is $105,000 to $169,050.
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://https://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.