SENIOR CLINICAL DATA MANAGER

Johnson and Johnson is currently seeking an Senior Clinical Data Manager located in Titusville, NJ; Raritan, NJ; OR Spring House, PA.
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.
The Senior Clinical Data Manager 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.
Primary 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.
o Gather and/or review content and integration requirements for eCRF and other data collection tools o Establish conventions and quality expectations for clinical data o Establish expectations for dataset content and structure o 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 Required.
4+ years experience in Pharmaceutical, CRO, Biotech, or Health related field or industry Experience in clinical drug development within the pharmaceutical or related industry Experience in clinical data review and knowledge of medical terminology Experience working with cross functional stakeholders and teams Strong written and verbal communication skills Team leadership experience (direct line management not required) 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 Knowledge of applicable international guidelines regarding data management of clinical trials Knowledge or 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 standard (i.
., CDISC, SDTM, CDASH, etc.) In-depth knowledge of project management and techniques 10% travel (domestic & international) The anticipated base pay range for this position in the US is $ to $.
The anticipated base pay range for this position in San Francisco Bay Area 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)).
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://www.
areers.
nj.
om/employee-benefits This job posting is anticipated to close on October .
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.