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NAMSA · 3 weeks ago

Manager Global Clinical Data Management

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

NAMSA is a pioneering organization focused on medical device materials for safety, shaping the industry since 1976. The Manager of Global Clinical Data Management will oversee a team working on clinical research data management and database development, managing client relationships and ensuring project success.

Medical Device

Responsibilities

Manage a group working with various clients and projects on clinical research data management and database development and validation in the medical device industry

Manage relationships with vendors providing database software to NAMSA Clinical

Allocates staff for projects – hourly and project-based

Is one of the principal spokespersons and the company’s primary interface with the customer

Negotiates technical, schedule and quality issues with the customer and utilizes Executive Management support as needed

Reviews cost and technical progress as compared to contractual requirements on a continual basis; takes appropriate actions to resolve issues and achieve client satisfaction

Participates in the NAMSA Clinical Operations Management Meetings

Reviews, edits and approves customer and hourly project subcontractor invoices and negotiates issues

Negotiates cost related issues with the customer (with the support of Senior Management)

Writes and manages project estimates and proposals as needed

Works collaboratively with cross-functional teams to increase company efficiencies

Identifies and guides process improvement projects

Maintains departmental vendor relationships

Updates Departmental Data Management SOPs, Work Instructions, and Guidelines

Prepares for and participates in client and regulatory agency audits; maintains audit readiness within the Department

Participates in meetings with prospective clients

Identifies opportunities to bring in new projects/clients

Negotiates with vendors

Offers opportunities to clients for expansion of MRO services to be provided by NAMSA

Initiates and guides ongoing MRO projects

Qualification

Data managementDatabase developmentVendor managementProcess improvementProject managementAudit readinessComputer skillsClient relationship managementCommunication skillsNegotiation skillsTeam collaborationTechnical writing