Website Lenox Executive Search
Long-term (up to 2 years) Contract role. Remote. Must have strong CRO OVERSIGHT experience.
Lenox Executive Search is seeking an experienced Senior Clinical Data Manager to fill an 24+ month remote contractual role with a global pharmaceutical company. Must have extensive CRO Oversight experience.
- BS/BA required preferably in a health-related, life science area
- Strong CRO Oversight experience a must have
- Minimum of 6 years data management and/or drug development experience.
- Large Pharma (Sponsor side) industry experience
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs
- Experience with all phases of development and at least 2 therapeutic areas.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience.
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
- Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
- Good understanding of CDISC standards, and experience implementing standards.
- Strong knowledge of clinical study reporting requirements including advanced knowledge of office software (Microsoft Office). SAS programming.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.
- Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
- Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
- Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and the Company for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other Company Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Provides input to functional governance with strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
- Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of the Company.
- Participates and represents function in formal inspections and audits as requested.