Senior Project Data Manager (Princeton, NJ)

Represent the Data Management Department on clinical project teams and manage data management aspects of clinical trial projects. Ensure accurate and consistent handling of clinical data, as well as ensure data management tasks are conducted according to applicable SOPs and GCP guidelines. 

• Responsible for reviewing clinical research protocols and/or Amendment for clinical trials.

• Function as Data Management representative on clinical project teams.

• Gather technical requirements from stakeholders for database setup by collaborating with programming team on eSource and EDC trials.

• Provide input for Case Report Form Development to ensure design meets CDISC standards.

• Liaise with external data vendors and cross functional teams to ensure development of database, data entry screens, dynamics within platform/application, edit check programs.

• Develop and manage data management documents i.e., Data Management plan, User Acceptance Testing plan (UAT plan) and script UAT Scenarios, etc.

• Participate and provide oversight for UAT of databases, other platform used for data collection i.e., Interactive Response Technology (IRT), devices, etc.

• Identify required modifications to the database in eSource or EDC to enhance quality and functionality of the platform by creating a Change control/migration log.

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

• Work on integration requirements and specification of platforms example: IRT & eSource platform, eSource CRF & eConsent application, and eSource & ePRO (Patent Reported Outcome)

• Perform data review and cleaning activities for EDC or eSource trials, including serious adverse event reconciliation. Proactively identify and implement opportunities for process improvement related to data cleaning activities.

• Manage external data vendors according to protocol and data transfer specifications (DTS), troubleshoot external vendor data accuracy.

• Liaise with Clinical Data Analysts for review and completion of SDTM annotated Case Report Form (aCRF) by reviewing the source data export received from eSource or EDC vendor.

• Identify data review requirements in the Integrated Data Review Plan (IDRP) per protocol based on the primary and secondary endpoints.

• Create programming requirements for JReview and SAS listings to identify inconsistency in data.

• Collaborate with e-platform teams to identify protocol specific requirements and UAT of reporting dashboards & visualization for ongoing data review and monitoring purpose.

• Investigate and resolve validation issues identified in development of trial design domains with programmers.

• Provide progress reports and data reports to the cross functional areas to review the health of the study. 

• Provide data management expertise to the team to illustrate potential data issues and offers proactive solutions.

• Make presentations for in-house project review, regional CRA, and/or Investigator’s meetings to ensure understanding of data management issues.

• Participate in Tables and Listing review meetings as Data Management representative and resolve data issues identified from various data sources.

• Ensure key milestones are met, including database set-up through lock and file all data management documents to Trial Master File (TMF)

• Provide input in the development of departmental standards and operating procedures.

• Telework is permitted.

• Up to 20% domestic travel.

Requirements:

• Bachelor’s degree in Pharmacy, Biochemistry, Chemistry, or a related scientific field.

• Five (5) years of experience in data cleaning and review in Phase I-IV studies.

• Five (5) years of experience in vendor management and managing data from eSource/EDC databases, ePRO, eCOA, IRT, digital technologies, lab, ECG, Spirometry, devices, and diary.

• Five (5) years of experience leading Data Management projects from Database set-up and maintenance to database locks and archiving in multiple therapeutic areas.

• Five (5) years of experience handling Pinnacle 21 issues.

• Five (5) years of experience with database structure, database programming requirements, and handling Business Intelligence and Risk Management Tools.

• Five (5) years of experience authoring Data Management documentation (DMP, CCGs, DTS and SAE guidelines).

• Two (2) years of experience with SQL and SAS programming languages to perform data quality checks.

• Two (2) years of experience applying CDISC CDASH/SDTM data standards.

Apply to:  Carole.McDonald-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.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

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