Associate Director, Clinical Data Standards

4-7 years

Not Disclosed

Basking Ridge

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Associate Director, Clinical Data Standards

Company Description

Daiichi Sankyo Group is committed to innovation and excellence in the pharmaceutical industry, leveraging over 100 years of scientific expertise to address unmet medical needs globally. With a presence in more than 20 countries and 16,000 employees, the company focuses on oncology and other critical research areas. Daiichi Sankyo promotes diversity and inclusion and is an equal opportunity employer.

Job Summary

The Associate Director, Clinical Data Standards, is responsible for developing, maintaining, and enforcing data standards in collaboration with internal and external stakeholders. This role requires expertise in Oncology, CDISC industry standards (SDTM, ODM.XML, CDASH), metadata management, and data mappings. The position demands leadership in data standards development, regulatory compliance, and supporting Daiichi Sankyo's research and development pipeline.

Responsibilities

Leadership, Direction, and Strategy

Lead implementation of therapeutic level clinical data collection requirements.
Establish Data Standards Governance Framework and develop continuous improvement metrics.
Drive Standards Governance Committee sessions to ensure therapeutic alignment with regulatory requirements.
Promote Daiichi Sankyo values and quality workplace culture through cross-functional and multicultural collaboration.

Project Management

Develop and promote clinical data standards strategy and infrastructure.
Identify and resolve data standards gaps throughout the trial lifecycle.
Standardize upstream data collection methodologies for efficient EDC design and build.
Maintain Daiichi Sankyo’s Clinical Data Standards libraries and related documentation.
Communicate and enforce clinical data standards across projects.

Functional Expertise

Lead data standardization initiatives to ensure compliance with CDISC SDTM standards and regulatory requirements.
Define, manage, and govern clinical data standards to optimize data collection.
Maintain and peer review key procedural documents to ensure data standardization.
Participate in technology selection to support diverse clinical data collection.
Provide input for standards components in team meetings.

Operational Efficiency / Continuous Improvement

Promote the value of data standards and build a network of data-driven methodologies.
Ensure coherence of standards initiatives cross-functionally and externally.
Develop training strategies for company-wide

adoption of Clinical Data Standards, initiate Data Standards Workshops, and create standards-driven frameworks and newsletters.

Stay updated on data collection trends, industry advancements, regulatory requirements, and emerging technology innovations to optimize Daiichi Sankyo’s clinical data standard processes.

Qualifications

Education

Bachelor’s Degree in life sciences or related field required

Experience

7 or more years of experience in a pharmaceutical, biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, including hands-on experience in all aspects of data activities.
7 or more years of experience in Oncology trials with an understanding of the complex and interdependent relationships between protocol development, data collection, CRF designing, analysis, and reporting preferred.
4 or more years of combined people and initiatives management experience required.

Additional Information

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.

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Associate Director, Clinical Data Standards

Job Description

Job Description: Associate Director, Clinical Data Standards

Company Information

Company Description

Job Summary

Responsibilities

Leadership, Direction, and Strategy

Project Management

Functional Expertise

Operational Efficiency / Continuous Improvement

Qualifications

Education

Experience

Additional Information

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