Associate Manage Clinical Data Management

Role: Associate Manager, Clinical Data Management

Location: Remote Working

Job Description

Participates in preparing function for submission readiness.

• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * 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.
• Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * Acts as a process expert for operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables
• Champions and adopts technology improvements and tools for use in clinical data management processes.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirement. Performs other duties as assigned.

Key Accountabilities-

Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.

• 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 in one or more therapeutic areas preferred.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience preferred.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

Special Skills/Abilities

• Advanced knowledge of office software (Microsoft Office).
• Experience with budget planning & management.
• Strong knowledge of relational databases and experience using multiple clinical data management systems.
• Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
• Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
• Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
• Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.