Seeking a Clinical Data Management Technology Contractor V for a 12 month assignment in Cambridge, MA.
• CRO oversight experience & either oncology or neuroscience – need one or the other, both is a plus.
Position Title: Senior Manager-Clinical Data Solutions
- Responsible for timely and high quality data management deliverables supporting the 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.
- Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets.
- Provides and enables solutions for complex problem solving that align with the Takeda values.
- Serves as a clinical data management expert and provides guidance on CDISC standards.
• 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 copmany 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 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.
• Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BS/BA required preferably in a health-related, life science area and with a minimum of 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 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 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.
• Access to transportation to attend various meetings held in proximity to the offices.
• Able to fly to various meetings at investigator, vendor or regulatory agency sites.
• Some international travel may be required.
For immediate consideration, please send your resume to firstname.lastname@example.org
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