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Summary
The Manager External Data Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety, 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, 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. The position will perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.).
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/or Partners. Performing oversight and execution of CDx development to facilitate science based CDx decision making would be preferable.
Responsibilities
Leadership, Direction, and Strategy:
- Leads implementation of Program/Therapeutic level external data collection requirements by partnering will internal (BDM, Non-BDM Functions) and external stakeholders (Central Labs, Vendors, Specialty Labs, etc.) to drive consistency of data acquisition, processing, and reporting of diverse external data across DS Programs.
- Participates in Contract/SOW reviews and MSA discussions of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs for DS Programs / Studies.
- Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of external data management activities by managing Program / Therapeutic level external data collection process, study requirements as well as the overall process.
- Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to ensure data standardization across programs.
- Acts as a primary point of contact for escalations related to quality of external data delivery. Identify quality issues pertaining to external data sets, data structures to ensure delivery is in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW.
- 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:
- Provides guidance for collection of all external data management deliverables for assigned DS Program / Studies by ensuring consistency of external data standards.
- Is accountable for quality delivery of diverse external data (ex: Central Labs, PK, ADA, Biomarker, Genomic, CDx, etc.) for DS Programs / Studies operating under the outsourced and in-house operating models.
- Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.
- Supports any external data related audit requests for assigned DS Programs / Studies; communicates to Vendors all / any problems related to data transfers, data structure deviations or validation issues.
- Complies with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.
- Monitor vendor metrics and provide feedback on performance to Joint Operational Committees (JOCs). Develop Key Performance Indicators and ensure sufficient tracking.
Functional Expertise:
- Ensures all external data contains protocol specified parameters, is in correct format and aligns with the approved EFTs and eDTS. Participates in review of Test and Production data transfers for diverse data sets and identifies any erroneous data.
- Lead Companion Diagnostics data management activities by acting as a liaison for CDx Operations, Data Management, CROs and oversee the Diagnostic Partners data transfer activities with functional and cross functional area leads.
- Collaborates with Study Data Managers to oversee quality of external data specifications being developed for DS Programs / Studies including adherence of specifications to CDISC / SDTM standards, identification of specs related deviations as well as issues management.
- Reviews external data transfer specifications, and SDTM requirements to support data integration, analysis, and reporting. Assists in the development of the Data Transfer Agreement and Data Transfer Specifications for Vendor data transfers.
- Reviews external data to identify any discrepancies and proactively forward erroneous data related findings to Study Data Managers for resolving data issues. Ensures adherence to external data processes, methodologies, data standards, and technologies for quality delivery of raw data sets.
- Contributes/participates in the selection of functional technologies, thereby developing optimal approaches to support the collection of diverse external data types.
- Advises Study Data Manager on complex vendor management issues and provides guidance or feedback to transfer agreement creation/updates as required.
Operational Efficiency / Continuous Improvement:
- Facilitate science based CDx decision making for data transfers coming to Daiichi Sankyo, maintain focus on IVD products by collaborating with Diagnostic Partners and technologies.
- Leverage comprehensive Data Management and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development for Daiichi Sankyo Programs.
- Lead the Data Management aspects of diagnostics across Daiichi’s early and late-stage oncology portfolios through close collaborations with internal and our external diagnostic partners.
- Applies GCP principles to ensure all external data management activities follow global SOPs, SOIs, and associated guidelines.
- Establish and maintain relationships with external vendors to optimize data exchange processes. Assist with review of External Data quality checks, External Data reports and / or External Data listings.
- 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.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:
- Bachelor's Degree or higher in life sciences or related field required
Work Experience:
- 5 or more years external data management background and strong knowledge of 3rd party vendor management and oversight of external data standards is required.
- Knowledge of CDISC and SDTM and industry standard data collection practices.
- Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease therapeutic area is a must.
- Working knowledge of Clinical trial data systems and/or EDC and related applications is a plus.
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.
