Clinical Data Manager manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Being a Clinical Data Manager standardizes data management procedures and documents departmental operating procedures. May require an advanced degree. Additionally, Clinical Data Manager typically reports to a manager or head of a unit/department. The Clinical Data Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Data Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Description:
POSITION SUMMARY
The Clinical Data Specialist III (CDS III) independently plans, conducts and reports the data management portion of large, complex or international projects and provides leadership on the value and best practices for data integration processes. The CDS III provides the expert leadership for defining data management project requirements, considerations and effective implementation options. The CDS III position is an experienced manager supporting Clinical Data Management (CDM) teams, coordinating projects, facilitating infrastructure initiatives and participating in business development activities. The CDS III may perform other CDS level and Program Manager responsibilities on a project.
WORK PERFORMED The CDS III independently plans and manages all project related data management activities to include project contracts and sponsor communication. The projects include international with multiple collaborators, partners or sub-contractors, and projects involving new technology
Skills:
Data, Management, CDM, Lead, Manager, Inform, RAVE, Clinical data, Data management, Edc, Data entry, medidata rave, Data Manager, Clinical, Late Phase, clinical research, vendor management, clinical trial management
Top Skills Details:
Data,Management,CDM,Lead,Manager,Inform,RAVE,Clinical data,Data management,Edc,Data entry,medidata rave
Additional Skills & Qualifications:
Project Management
Contributes to the data management portion of the scope of work and protocol.
Provides input and assistance to Program Manager for scope of work changes.
Oversees projections for project data management work.
Maintains accountability to the Project Lead for data management deliverables and timelines.
Manages internal and external customer expectations.
Risk Assessment-Proposes solutions to project risks; collaborates with the Project Leader and/or Program Manager to manage risk.
Communication -Oversees communication with Project Leader, project team, sponsor and project stakeholders regarding project data management items.
Timelines -Oversees CDM project specific timelines.
Coordinates with cross-functional team to develop and manage project timelines.
Data Coordination
EDC Support - Oversees processes in support of EDC account management on projects.
Oversees coordinate and resolution of project integration issues. (e.g., IxRS, SADI, data load issues).
Manages project related issues.
Oversees project lock procedures for systems within the CDMS (e.g., EDC database, integrations).
Audits Supports internal and external audits; develops and oversees execution of corrective action plan.
Stays current with applicable regulations and guidance.
Project Documentation
Supervises maintenance of project documentation in a centralized location for the duration of the project; to include, but is not limited to, a project profile, specifications, testing, and project data management training.
Supervises maintenance of project documentation in a centralized location for the duration of the project; to include, but is not limited to, a project profile, specifications, testing, and project data management training.
Meetings - Directs internal and external project team meetings that may include cross-functional groups, sponsors and external stakeholders (e.g., data management team meetings, on-line review).
Experience Level:
Expert Level
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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