Clinical Data Management Lead
Proclinical is currently recruiting for a Clinical Data Management Lead for a global biotechnology company located in Cambridge, MA. Successful candidate will establish asset and study level strategies and services, including excellence in the application of standards.
- Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Provides input to functional governance with company's 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.
- Participates and represents function in formal inspections and audits as requested.
Skills and Requirements:
- BS/BA required preferably in a health-related, life science area and with 10+ years data management and/or drug development 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 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 SAS programming.
- Advanced knowledge of office software (Microsoft Office).
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.