Senior Clinical Data Manager
Proclinical is currently recruiting for a Senior Clinical Data Manager with a pharmaceutical company located in Boston, MA.
- Responsible for timely and high-quality data management deliverables supporting the company portfolio.
- Establish asset and study level strategies and services, including excellence in the application of standards.
- Conduct oversight using, predictive data monitoring practices from database activation through database release and submission.
- Contribute to the management of vendor partnerships to maximize effectiveness and maintain budgets.
- Clinical data management expert
- Provide guidance on CDISC standards.
- Responsible for vendor oversight activities, represents data management function for all data related deliverables, in support of key decision points and regulatory submissions.
- Provide input to functional governance with strategic suppliers, partner with stakeholders to resolves issues escalated from the vendor or cross-functional teams.
- Ensures achievement of major data management deliverables.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Oversee the planning and management of external Data Management budgets and timelines.
- Represents function in external professional initiatives and organizations.
- Participates and represents function in formal inspections and audits as requested.
Skills and Requirements:
- Bachelor's Degree required; advanced degree preferred.
- 10+ years of experience in data management or drug development.
- 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.
- Experience with NDA and CTD.
- Knowledge of (e)CRF design and data management functions and activities.
- Understanding of CDISC standards.
- Advanced knowledge of office software.
- Understanding of clinical trial documents and processes.
- Knowledge of FDA and ICH regulations.
- Experience in medical coding and knowledge of coding tools and programming such as SAS.
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 contact Amanda Rivera at 267-435-5888 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.