Senior Manager CDM
Proclinical is currently recruiting for a Senior Manager of Clinical Data Solutions with a global pharmaceutical company located remotely. As the Senior Manager, you will be responsible for data management oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and company SOPs), on schedule and on budget.
- 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 the 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 of the company.
- 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.
- 8+ 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.
- 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.
- Able to influence without authority.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
- Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.
If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or email@example.com.
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.