Analyst II, Clinical Data Manager

Analyst II, Clinical Data Manager

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Johnson & Johnson Innovative Medicine R&D is recruiting for an Analyst II, Clinical Data Manager. This position is a hybrid role and can be located in Raritan, NJ;
Titusville, NJ; or Spring House, PA.

The Analyst II, Clinical Data Manager is a professional individual contributor role at the junior level that will provide oversight and accountability and/or execute data management activities and/or perform scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. This individual will make recommendations and influence decisions for specific trials or assignments.

Analyze and provide input into decisions with direction from manager or Data Management Leader (DML). The work is received in broad terms and is reviewed on an ongoing basis with the DML and the amount of instruction is limited.

Principal 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 to the business for assigned trial(s) to include but not limited to:
• 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…