Sr. Manager/Associate Director, Clinical Data Management
Position Description & Responsibilities
The Sr. Manager/Associate Director, Clinical Data Management, is responsible for guiding and managing all clinical data management activities according to quality standards, ICH guidelines, GCP and regulatory requirements. The person, reporting to the Head of Biometrics, is also responsible for managing the data management team to ensure the staffing and the operational aspects of the data management group are in line with the company R&D programs.
Roles and responsibilities include the following:
- Represent clinical data management in meetings with internal cross-functional teams, external vendors and regulatory agencies
- Oversee and participate in all data management activities for multiple clinical development programs, such as vendor evaluation, CRF development, database specifications, user acceptance testing, query resolution, data review and data base lock
- Collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Project Management, and CMC in support of project deliverables and regulatory needs
- Create thorough data quality checks and data review strategies to ensure the integrity of the clinical data
- Review data transfers for consistency with available specifications, e.g. SDTM specifications, annotated CRFs
- Contributes to development of outsourcing strategies and relationships with outsourcing partners or CROs
- Participate in the data preparation for the NDA/EMA submission
- Recruit and train high performing data management staff
Successful candidates will have the following background/experience:
- Minimum of BS preferably in Health Sciences, Statistics, MIS or Computer Science. MS preferred
- Minimum 6 years in Clinical Data Management; 2 years prior management experience desired.
- Thorough knowledge of applicable regulatory rules and ICH guidelines
- Strong expertise in electronic data capture systems of a variety of platforms
- Knowledge of SDTM models and experience transforming raw data into those standards
- Complex and/or international trials experience
- Previous NDA/EMA experience is desired
Vanda Pharmaceuticals offers a competitive compensation package with excellent benefits and a 401(k) matching program. Vanda is an equal opportunity employer, committed to the hirin
g, advancement and fair treatment of individuals without regard to race, color, religion, sex, sexual preference, age, national origin, ethnicity, disability, or any other protected
status designated by law.
Applicants should submit a cover letter with their Curriculum Vitae or Resume to:
Reference #: I6007
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Avenue NW, Suite 300E
Washington, DC 20037
"Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility."
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