NAMSA

Manager, Global Clinical Data Management

NAMSA

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • 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

Requirements

  • Bachelor’s degree required; advanced degree is a plus
  • 3+ years of prior management experience of data management group preferred
  • Prior work experience in database management role preferred
  • Fluency in English and local language, if different, required
  • Demonstrates computer skills including Access, Word, Excel and Power Point
  • Experience with data management activities and database development/validation process
  • Knowledge of data collection requirements in medical device industry
  • Familiarity with electronic data capture (EDC) systems
  • Knowledge of standards, regulations and technical resources to meet customer expectations and regulatory requirements
Benefits
  • Reasonable accommodations for individuals with disabilities
  • Extensive use of a computer keyboard

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
data managementdatabase developmentdatabase validationproject managementprocess improvementcost negotiationaudit readinessdata collection requirementselectronic data capture (EDC)
Soft skills
relationship managementcommunicationcollaborationnegotiationleadership
Certifications
Bachelor's degreeadvanced degree