NAMSA · 1 day ago
Senior Manager, Study Director Group
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
$121K/yr - $150K/yr
8+ years expNAMSA is a pioneer in the medical device industry, focusing on materials safety. The Senior Manager, Study Director Group will manage operations, supervise scientific staff, and oversee study protocols to ensure compliance and quality throughout the research process.
Medical Device
Responsibilities
Manages the overall operations of the study director group, including planning and organizing all start-up and ongoing study activity for the organization, as well as determining and planning for all equipment, supply, staff and space needs
Supervises Scientific staff, both directly and in conjunction with department leaders, including training, planning, assigning and directing work, evaluating performance, rewarding and disciplining employees, addressing complaints and resolving problems. Participates in the hiring and termination process
Oversees and advises Study Directors in the protocol development and report preparation process with regard to scientific, technical, and regulatory merit. Provides oversite of study conduct as necessary, interpreting quantitative data and qualitative behavioral assessments
Assesses and implements process improvements to support study delivery from sample submission through report delivery. Ensures appropriate utilization of Associates, and develops, motivates, and mentors Managers, Supervisors and Associates
Works in conjunction with test facility management to assign the GLP studies based on workload, educational requirements, technical aptitude, training and expertise to a study director
Schedules and coordinates scientific activities and study assignments based on client studies and expected completion dates
Coordinates with department management company-wide to ensure the scheduling of study activities, report preparation and other client-related communications are appropriate and timely, and to ensure all necessary study specific requirements such as test and control articles, instruments, disposables and other materials are ready and available according to written protocols
Manages study director activity and workload to ensure that expectations pertaining to scientific rigor, experimental quality, and interpretation of results are consistent within the department and the company
Maintains qualified staff by managing the recruitment, selection, orientation, and training of Associates in the Study Director departments
Provides training and operational support to laboratory sites’ Study Director Teams as needed
Reviews, updates and develops scientific-related SOPs and other technical documents to reflect current policies and practices. Works in conjunction with Quality leadership to develop and maintain GLP-compliant processes
Responsible for the collecting metrics evaluating the effectiveness and quality of operational processes and business goals and provides frequent updates to the management team. Develops and maintains standardized data review methods and metrics in cooperation with other departments
Accomplishes financial objectives by forecasting requirements/capacity, provides annual capital estimates and expense budgets, scheduling expenditures, analyzing variances, and initiating corrective actions if necessary
Assists with preparation of departmental business plan and assists with meeting established departmental goals
May oversee and delegate submissions and responses for IACUC review
Other duties and responsibilities as assigned
Qualification
Required
Requires 8 years related experience including 3 years supervisory experience
Requires a Bachelor's degree in a scientific discipline (Masters preferred)
Strong working knowledge of AAALAC, USDA, FDA, and GLP regulations
Preferred
Interventional/surgical or medical device research experience, with knowledge of and experience with technical operational processes and functions of an interventional/surgical testing setting preferred
Company
NAMSA
NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2020-09-01Acquired
Leadership Team
Matthew Micowski
SVP & CFO
Timothy Mitchell
VP - Strategic Partnerships & MRO
Recent News
Medical Device Network
2026-01-11
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