The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan, and oversees the compliance activities across multiple CROs as it relates to data management. The scope of this role may span multiple programs and across multiple CROs.
ResponsibilitiesResponsible for third party vendor oversight activities across global development programs.
Represents data management function 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 or Leads 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.
Educational qualifications:
MS or BS in health-related, life sciences area or technology-related field.
Minimum Work Requirements:
Minimum of 8 years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
Experience building studies in RAVE.
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.
