Senior Manager, Study Director Group

NAMSA•Minneapolis, MN

About The Position

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • 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.

Requirements

Requires 8 years related experience including 3 years supervisory experience
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.
Requires a Bachelor’s degree in a scientific discipline (Masters preferred)
Strong working knowledge of AAALAC, USDA, FDA, and GLP regulations.

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.