J&J Family of Companies - Senior Clinical Data Manager - Lansing, Michigan
Job ID: 2406217367W
Description
Johnson and Johnson is currently seeking a 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.
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. This position also makes recommendations for processes, timing, structure, and resources at a program level.
Primary responsibilities:
- Take a leadership role with external suppliers, trial customers, and other internal/external partners to establish, align, and confirm data management expectations for assigned trial(s).
- Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.
- Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables.
- Take a leadership role to obtain and share best practices with internal partners.
- Create key functional plans ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Identify and participate in process, system, and tool improvement initiatives.
- Perform scientific study data review and management of CDM, SRS, and Study Responsible Physician related queries in the EDC system.
- Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
Qualifications
Education:
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
- 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 of technology platforms and systems to capture and process data
- Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.)
- In-depth knowledge of project management and techniques
- 10% travel (domestic & international)
Compensation:
The anticipated base pay range for this position in the US is $105,000 to $169,050. This position is eligible for an annual performance bonus and various employee benefits.
Application Information:
This job posting is anticipated to close on October 18, 2024. The Company may extend this time-period as needed.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
Primary Location: NA-US-New Jersey-Raritan
Other Locations: NA-United States, NA-US-Pennsylvania-Spring House, NA-US-New Jersey-Titusville
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