Director, Data Management Reporting
Location: Basking Ridge
Posted on: June 23, 2025
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Job Description:
Join a Legacy of Innovation 125 Years and Counting! Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 125 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 18,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of
medicines for cardiovascular diseases, under the Group’s 2025
Vision to become a “Global Pharma Innovator with Competitive
Advantage in Oncology,” Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. Job
Summary: The Director of Data Management (DM) Reporting provides
leadership in Data Management Operations for the Data Validation
and Reporting function by collaborating with internal and external
stakeholders to oversee the development and delivery of clinical
data programming, reporting, data visualizations, external data
acquisition and validation, and tools to support project portfolio
across drug programs. This role is responsible for ensuring the
quality and timely delivery of programming deliverables, including
integrated data review plan (IDRP), study data listings and
exception reports, sample data reconciliation, external data
acquisition, validation, and reconciliation, study data protection,
operational metrics, and clinical trial quality and risk management
reporting requirements that adhere to programming standards and
specifications across clinical studies. This position involves
managing direct reports and/or leading multidisciplinary teams, as
well as overseeing functional service providers to achieve business
objectives. It requires extensive knowledge of clinical data
programming, external data handling, techniques, standards,
methodologies, and skills in working with internal and external
systems, CROs, and vendors. Excellent verbal/written communication,
analytical, organizational, and interpersonal skills are essential
for effective collaboration with individuals at different levels
and from diverse disciplines and cultures. Line management
experience, the ability to manage and coach people, and the
capability to lead multiple projects concurrently are crucial for
this role. Advanced knowledge of Data Management, Biostatistics,
Clinical Operations, Pharmacovigilance, handling and processing of
raw data and external data, CDASH/SDTM, industry best practices,
and relevant regulatory requirements is essential. This position
demands significant skills in working in fast-paced environment,
continuous improvement, project management, change management, and
risk management. Responsibilities: Leadership, Direction, and
Strategy: Is accountable for the management and oversight of all DM
programming, reporting, and external data acquisition and
validation deliverables for all studies consistent with IDRP, study
data listings, exception data listings, sample reconciliation,
external data acceptance and reconciliation reports, study data
protection, operational metrics, and clinical trial quality and
risk management reporting requirements. Oversees the execution of
external data acceptance, storage, and delivery activities to
ensure complete, high-quality data is available for use by clinical
study teams in a timely manner. Provides oversight for external
data validation and quality control process for verification of the
data structures in line with data transfer agreements. Manage and
oversee the DM programming staff and Functional Service Provider
subject matter experts at the functional level to support project
portfolio milestones, and/or initiatives to achieve/exceed
departmental quality/time/cost objectives. Leads development and
implementation of DM reporting strategy and solutions at the
program level to achieve/exceed quality, time, and cost objectives
embracing agile programming methodologies, novel approaches, and
industry best practices. Drives execution of the DM programming,
reporting, and data visualization activities across all studies to
ensure on-time delivery of accurate and high-quality programming
deliverables. Champions and facilitates change management through
providing rationales, describing improved outcomes and increased
efficiencies to achieve programming operational excellence.
Provides strategic input, develops tactical approaches, and
proposals to advance DM Data Validation and Reporting initiatives.
Leads or participates in departmental and/or multidisciplinary
teams working on continuous process improvements and other
initiatives. Proactively identifies and manages risks to data
quality, data integrity, programming and reporting deliverables,
and timelines. Collaborates with various Governance/Steering
Committees, Functional Line Management, and multidisciplinary teams
to develop, implement, and promote efficient programming
methodologies and techniques, optimizing programs and outputs for
quality, efficiency, and positively influencing daily operations.
Functions as the DM Operations Data Validation and Reporting
escalation point for all programming, reporting and external data
validation deliverables across all studies; proactively develops
solutions within and across functions and resolves complex issues
and conflicts in a timely manner. Identifies Data Validation and
Reporting staffing needs, prepares annual resource projections,
monitors staff utilization, participates in assessment and hiring
of candidates. Performs line management duties (provides feedback,
conducts formal reviews, confirms training completion, and drives
career development) for direct reports, and mentors DM Operations
Data Validation and Reporting staff. Directs programming
representation in audits and regulatory inspections to provide
relevant programming and reporting information as needed. Provides
input for DM questions in health authority information requests.
Builds and maintains positive business relationships with other
line functions, vendors, and partners; is an ambassador and
advocate for the data operations programming function with key
internal and external stakeholders. Promotes Daiichi Sankyo values
and quality workplace culture, collaboration in cross-functional
and multicultural settings. Represents Daiichi Sankyo DM at
professional conferences/meetings. Project Management: Is
accountable for the completion of DM programming, reporting,
external data acquisition, processing, and validation activities
for drug programs under the outsourcing and in-house operating
models. Is accountable for the quality, integrity, and timely
delivery of all external data in line with the established data
transfer agreements. Is accountable for oversight for DM Data
Validation and Reporting resources, CROs, and vendors to ensure
compliance with the programming standards and practices, SOPs,
external/internal data standards, Good Clinical Practices (GCPs),
applicable regulatory requirements, and other relevant guidelines.
Accountable for inspection readiness of DM programming
documentation filed/archived according to applicable Daiichi Sankyo
and regulatory requirements. Communicates with Data Operations
leadership, asset leads, DM staff, and cross-functional team leads
regarding goals, expectations, timelines, overall status, risks,
data trends, and issues. Proactively responds to the needs of the
asset leads, DM staff, and cross-functional teams and influences
appropriately to ensure successful delivery of the programming
deliverables aligned to business priorities. Leads prioritization
and planning with the teams to ensure outcomes meet expectations.
Functional Expertise: Assesses vendor Scope of Work for Data
Validation and Reporting needs; engages in vendor meetings; reviews
and evaluates RFPs; contributes to the proposals for contracted
programming external data services; manages vendor relationships by
coordinating at the governance level. Instills incorporation of
industry DM programming best practices, reporting technologies, and
discipline to achieve operational excellence. Accountable for
adherence to DM programming standards, methodologies, data
standards, and reporting technologies ensuring quality delivery of
DM programming and reporting services. Provides guidance and
expertise on programming of complex data listings and reports,
usage of tools and technologies, data extraction mechanisms, data
visualizations, and automation to advance the maturation of
programming, reporting, and external data validation capabilities.
Expertise in code optimization, frameworks/libraries, testing
strategies, ETL/ELT capabilities, optimizing data flows, data
normalization, reporting processes; data and programming standards;
emerging data capabilities and methods. Implements
quality-by-design approaches to confirm the quality, integrity, and
fit-for-use of the external data based on appropriate and/or
established data-cut-off as a pre-requisite for database lock.
Operational Efficiency / Continuous Improvement: Provides
leadership for operational efficiencies and productivity gains
through improved programming standards, code optimization and
reuse, data capabilities and methods, and automation. Challenges
the status quo, encourages innovation, takes suitable risks to
drive improved outcomes through agile programming methodologies,
novel approaches, and technology aimed at improving quality and
efficiencies. Evaluates repetitive tasks, programming errors,
testing strategies, and expedites the delivery of high-quality
outputs through automation. Establishes key performance indicators
and continuously monitors them to detect trends and pinpoint areas
for enhancements. Leads or participates in cross-functional process
improvement initiatives. Maintains awareness of and disseminates
information about emerging trends, best practices, data standards,
clinical programming methods, techniques, and technology
recommendations to enhance business capabilities, improve
compliance and achieve operational efficiencies. Develops and
maintains networks with thought leaders in DM and related areas.
Qualifications: Successful candidates will be able to meet the
qualifications below with or without a reasonable accommodation.
Education: Bachelor's degree in life sciences or related field
required Master's degree in life sciences or related field
preferred Experience: 11 or more years of experience with Bachelors
(or 9 with Master's degree). Experience includes database and data
validation programming and/or related work experience in a medical
device, biotech, or pharmaceutical company, or similar environment
(e.g., CRO); knowledge of industry standard clinical technologies,
data standards, raw data handling and processing, external data
acquisition, validation, reconciliation, and data
visualizations/analytics experience required 5 years managing
people required 5 managing initiatives required 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: , Danbury , Director, Data Management Reporting, Science, Research & Development , Basking Ridge, Connecticut
