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 TA 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. An advanced degree (Master’s, PharmD, PhD) is 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.