Managing Director leading the NFTC Foundation’s initiatives on U.S. global economic leadership. Driving campaigns, managing resources, and collaborating with stakeholders in policy and trade affairs.
About the role
- Associate Director in charge of clinical data management and standards development for research-intensive biopharmaceutical company. Ensuring adherence to industry standards and governance processes.
Responsibilities
- Define standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations
- Ensure the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables
- Lead standards data governance reviews
- Contribute to the definition and maintenance of business processes related to the definition, use, maintenance, and sharing of clinical data standards
- Lead or participate in department initiatives, cross-functional working groups, and process improvement activities
- Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and make frequent contacts external to the area and/or company
- Maintain knowledge of new technologies, industry standards, regulatory requirements, and our company's guidelines and SOPs
- Work independently or as a team member with equal effectiveness
- Interact with staff across multiple company sites
Requirements
- B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline
- 8+ years’ work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development
- Advanced knowledge and leading-edge skills in clinical data standards
- Study Data Tabulation Model (SDTM) expertise
- InForm expertise
- Analysis & Reporting experience
- Program-level clinical and business requirements knowledge
- Strong communication and presentation skills
- Proficient in education, training, and facilitation.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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