Director, Data Management

Otsuka is a healthcare company motivated by our purpose and defined by our beliefs. Otsuka DM is part of the Clinical Analytics department and supports the efficient development and delivery of the clinical pipeline. This leadership role will report directly to the Sr Director, Data Management, and be responsible for line management of Associate Directors, providing direction for DM organization and supporting Otsuka affiliates and Alliance Partners to ensure consistency in data reporting and structure.

Job Description

• Oversee the Program Leads to ensure resources are aligned to implement ongoing projects and initiatives.
• Oversee all aspects of SDTM programming with a focus on strategic and technical leadership.
• Provide leadership by driving priorities, assigning projects and mentoring Associate Director.
• Ensure successful adoption of data processes, standards and best practices across DM organization
• Accountable for strategies and data processes to ensure consistency, compliance, and efficiency
• Lead the development of procedures and processes for data management organization
• Lead business process changes in the context of data standardization and provide subject-matter expertise and SDTM support to cross-functional teams.
• Develop programming standards, templates, and library to ensure consistency, improve quality and reduce SDTM programming timeline for clinical studies.
• Oversee audits/inspections, including mentoring, interview prep and CAPA resolution.
• Coordinate Global Data Management activities with Otsuka affiliates and CRO Partners.
• Serve as Data Management Liaison with alliance partners on submissions.
• Evaluate technologies for continuous improvement and efficiency of DM organization.
• Provide oversight of project timelines, budgets, and define KPIs and KRIs.
• Serve as main contact for contracts and budgets with vendors.
• Work with key stakeholders for submissions.
• Ensure that appropriate training is in place so that staff is adequately trained to perform job requirements.
• Manage MDR (metadata repository) and associated DSP (data standardization platform) system to upgrade, and develop solutions.
• Serve as SDTM subject matter expert and collaborate with Clinical Analytics team, to contribute to best practices and governance requests.
• Provide consult, analysis, and support across multiple therapeutic area studies in their CDISC compliance and consistency in mapping.
• Serve as escalation point for Program Leads.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Expertise in design, conduct and locking of data in clinical trials at all phases.
• Solid knowledge of medical and clinical practices with understanding of medical concepts and terminology.
• Comprehensive knowledge of CDISC standards.
• Advanced knowledge and leading-edge skills in CDISC industry standards, including SDTM, CDASH and controlled terminologies.
• SAS or SQL programming skills.
• Expert understanding of industry processes related to data, ICH, GCP and Regulatory guidelines.
• Knowledge of clinical data standards, regulatory submission requirements including current global landscape.
• Able to communicate thoughts/ideas in an unambiguous manner and adjust communication based on audience.
• Capacity to remain flexible, frequently re-assessing and re-prioritizing projects based on business needs.
• Active and effective communication with strong oral and written communication and presentation skills.
• Ability to effectively multi-task in a high paced environment.
• Ability to exercise independent judgment in the decision-making process.
• Experience building data management teams and co-leading or developing initiatives.

Educational Qualifications

• Bachelor's or Masters degree (preferred) with a minimum of 12 years of experience in data management and pharmaceutical industry experience.
• 5 years of supervisory experience.

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

Disclaimer: 

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.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

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