Associate Director, External Data Management
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: April 24, 2024
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Job Description:
Join a Legacy of Innovation 110 Years and Counting!
Company is committed to diversity and inclusion. We are an equal
opportunity employer including veterans and people with
disabilities.
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.
Keywords: Daiichi Sankyo, Inc., Plainfield , Associate Director, External Data Management, Executive , Basking Ridge, New Jersey
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