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Summary
The Associate Director, External Data Management, is accountable for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering with internal and external stakeholders (e.g. Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics Partners, etc.) to optimize data collection services on behalf of Daiichi Sankyo.
This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, etc.) thereby serving as a subject matter expert for all external data management business needs.
This position also requires knowledge of external data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for integrating and importing external data received from CROs, vendors and other Partners. In addition, excellent verbal/written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are some of the requirements of this role. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change and risk management.
Responsibilities
- Leadership, Direction, and Strategy:
Leads implementation of department-level strategies for external data management activities and drives consistency of data acquisition, processing, and reporting of external data across programs. Monitor vendor performance by collection and review of metrics and key performance indicators such as successful achievement of target timelines and meeting critical study milestones. Participates in Contract/SOW reviews and MSA discussions of external vendors by engaging with key cross-functional stakeholders (Clinical Operations, Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, data standards and data cleaning needs for DS Projects. Attend bid defenses and/or vendor selections and work alongside DS Procurement and DM operations to qualify preferred data vendors to ensure DSI data collection and processing requirements are met. Serve as the subject matter expert to data management staff during the planning/start-up, conduct and close-out of external data management activities by managing external data processes including providing guidance to Project teams for complex data collection deliverables. Accountable for the development, maintenance and authorship of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), Data Structure Specifications (eDTS) to ensure data standardization across programs. Identifies needs for process improvements as related to external data acquisition, and establishes external data standards, reinforces adherence to existing data standards. Acts as a point of contact for escalations related to external data delivery quality. Ensures consistency in understanding and implementation of external data standards. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners.
- Project Management:
Is accountable for quality of delivery in external data management activities under the outsourced and in-house operating models. Collaborates with Study Data Managers to oversee quality of external data, transfer standards, and issue management. Ensure consistency of standard implementation across programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. Participates in audits as an external data management subject matter expert and provides guidance and/or training to study teams in preparation for upcoming audits. Complies with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.
- Functional Expertise:
Ensures adherence to external data processes, methodologies, data standards, and technologies for quality delivery of DM external data services. Provides guidance to cross-functional planning to define and set external data management deliverables at the department level. Contributes/participates in the selection of functional technologies, thereby developing optimal approaches to support the collection of external data. Evaluates external vendor Scope of Work and participates in vendor Request for Proposal and Change Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a subject matter expert and contributor to DM data standards team and represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance or feedback to transfer agreement creation/updates as required. Monitor vendor metrics and provide feedback on performance to joint operational committees. Develop Key Performance Indicators and ensure sufficient tracking.
- Operational Efficiency / Continuous Improvement:
Lead knowledge sharing, training sessions, and facilitate lessons learned discussions within the department. Establish and maintain relationships with external vendors to optimize data exchange processes. Leverages comprehensive Data Management and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data management activities follow global SOPs, SOIs, and associated guidelines. Remains current with and disseminates information about external data trends and advancements, regulatory requirements, and emerging technology innovations to optimize Daiichi Sankyo external data processes. Develops and maintains networks with thought leaders in external data management.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Master's Degree in life sciences or related field preferred
- Bachelor's Degree in life sciences or related field required
Experience Qualifications
- 7+ years external data management background and strong knowledge of 3rd party vendor management and oversight of external data standards. Knowledge of CDISC and SDTM and industry standard data collection practices preferred
- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease required
- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.