SENIOR CLINICAL DATA MANAGER

Johnson & Johnson is currently seeking a Senior Clinical Data Manager located in Raritan, NJ.
Remote work options in the United States may be considered on a case-by-case basis and if approved by the company.
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.
nj.
om/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Position Summary.
The Senior Clinical Data Manager is a professional individual contributor role at experienced level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials.
The Senior Clinical Data Manager makes 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 also makes recommendations for processes, timing, structure, and resources at a program level.
Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited.
Work is reviewed with the Data Management Leaders, or the immediate manager as needed.
Key Responsibilities.
Take 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 eCRF 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; participate in Regulatory Agency and J&J 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.
.
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 related queries in EDC system.
Involvement in other clinical data review activities (e.
., Coding, 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 Education.
Bachelor’s degree required Master’s degree or PhD preferred Experience and Skills.
Required.
Minimum of 4 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
Experience in clinical drug development within the pharmaceutical or related industry.
Experience working with cross functional stakeholders and teams.
Strong written and verbal communications skills (in English).
Team leadership experience.
Strong clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
In-depth knowledge of current clinical drug development processes.
In-depth knowledge of applicable international guidelines regarding data management of clinical trials.
Knowledge of technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange.
Knowledge of current industry standards (i.
., CDISC, SDTM, CDASH, etc.).
In-depth knowledge of project management and techniques and knowledge of team management principles.
Experience in clinical data review or significant experience with clinical data review and knowledge of medical terminology Other.
Approx.
The anticipated base pay range for this position is $ to .
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.
https://www.
areers.
nj.
om/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 December .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.