Analyst II, Clinical Data Manager

About the role

The Analyst II, Clinical Data Manager position is a hybrid role that can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA. This role provides oversight and accountability for data management activities and performs scientific data reviews for trials of varying complexity.

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 for assigned trials.
• 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.
• Excellent verbal and written communication skills are essential.
• The ability to adapt to a rapidly changing organization and business environment is required.
• The ability to collaborate with all levels of management across a matrix environment is required.

Benefits

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; 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; Condemnation 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.