Senior Clinical Data Manager

Responsibilities

• Responsible for independently leading data management study activities, CRO oversight, and driving deliverable timelines.
• Strong knowledge of EDC builds utilizing RAVE.
• Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
• Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
• Participates and represents function in formal inspections and audits as requested.
• 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.
• Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
• 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.
• Ensure compliance with own Learning Curricula, corporate and/or GXP 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.
• Performs other duties as assigned.

Qualifications

• Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience.
• Bachelor\’s Degree in a science, health related, or IT field.
• Minimum 6 years\’ experience in Clinical Data Management at the CRO or pharma level.
• 2 years as a CDM lead.
• Experience with all phases of development.
• Strong knowledge of data management best practices and technologies.
• Experience with Elluminate is not required but preferred.