Senior Project Data Manager

Senior Project Data Manager

Otsuka Pharmaceutical Development & Commercialization, Inc.

Princeton, NJ

Responsibilities:          

As member of the Clinical Analytics Department, support the efficient and effective development and delivery of the clinical pipeline. Coordinate assigned data management activities for clinical studies and represent Data Management as the primary point of contact with clients and internal members of the study team.  Represent the Data Management Department on project teams and manage data flow from collection to submissions.  Provide technical expertise to project teams.  Specific job duties include:

• Serve as data management lead and oversee data management deliverables at a project level.

• Coordinate all data management activities, including the development and maintenance of eCRFs/eSource, Edit Check, User Acceptance Testing (UAT), Data Management Plan (DMP) and other data management deliverables from study startup to database lock.

• Manage and prioritize project deliverables per study timelines and communicate with the study team throughout the course of the study.

• Perform comprehensive review of protocol for consistency and provide feedback to study team in order to facilitate accurate data collection.

• Analyze study data metrics to assess data quality and track/manage study progress related to data management activities.

• Assist in developing and maintaining data management standards, processes and working practices.

• Provide data management input and leadership on assigned initiatives.

• Proactively identify and implement opportunities for process improvements.

• Assist in data acquisition from external data sources with Data Analyst on creating data transfer specifications, e.g., central laboratories and CROs.

• Create programming requirements for J-Review and SAS listings to identify data trends.

• Ensure compliance with working practices and data management processes.

• Collaborate and coordinate Data Management activities with affiliates.

• Manage third party vendor (e.g., Contract Research Organizations (CRO)) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.

• Communicate with CRO vendors and internal project teams to ensure that project timelines are met with quality and efficiency.

• Provide input to the data management study budget and oversight of vendor budget(s).

• Ensure data management related presentations for investigator meetings adhere to company requirements.

• Assist and support data management audits and inspections.

• Mentor data managers on clinical data management processes and provide data management expertise.

• Approximately 20% domestic travel required.

• Remote work is permissible.

Requirements:

• Master’s degree or foreign equivalent in Computer Science, Data Science, Healthcare Informatics or a related quantitative field.

• Four (4) years of experience working with data management in different phases of clinical trials within the pharmaceutical industry.

• Four (4) years of experience with vendor management and managing data from eSource/EDC databases, ePRO, eCOA, IRT, digital technologies, lab, ECG, Spirometry, devices, and diary.

• Four (4) years of experience with International Council for Harmonisation (ICH), Good Clinical Practice (GCP) and 21 CFR Part 11 guidelines.

• Four (4) years of experience in leading Data Management projects from set-up and maintenance to database locks in multiple therapeutic areas.

• Four (4)years of experience with electronic data capture systems, eSource and data review tools (e.g., Jreview, Spotfire, Tableau, etc.).

Compensation:  $165,00 to $185,000 per year + benefits package (employer provided insurance, paid time off, 401(k), etc.)

Apply to:  missy.zahler-cw@otsuka-us.com.  Otsuka Pharmaceutical Development & Commercialization, Inc.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.