Associate Director, Global Clinical Study Management

NAMSA

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: • Provides leadership and management direction to the Clinical Operations function. • Build effective working relationships with both internal and external partners; may act as a Strategic Partner with key clients. • Assists direct reports in developing effective strategies for communicating with and motivating project team members. • Intervenes and problem-solves with challenging clients as necessary. • Participate in resource planning to ensure project deliverables and client goals are met; ensure Associates are assigned clinical projects that are appropriate for their skills and training. • Accomplish clinical department financial objectives by forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions. • Confirm appropriate regulations and quality are applied within study and site management activities supported by NAMSA. • Work with staff to ensure client expectations are met including the schedule, cost and quality of our services. May lead projects, as needed, to meet key milestones, deliverables, or organizational goals. • Maintain qualified staff by recruiting, selecting, orienting, and training Associates and Managers. • Provide training and development opportunities to direct staff via personal development plans, quality oversight/assurance and/or career path planning. • May act as business owner for one or more NAMSA Clinical applications (e.g. CTMS, eTMF). • Lead continuous process improvement initiatives to drive efficiency and innovation within the Clinical organization. • Support review of proposals and provide input as needed. • Participates in meetings with prospective clients. • Identifies opportunities to bring in new projects/clients. • Offers opportunities to clients for expansion of Clinical services to be provided by NAMSA. • May represent the company and its capabilities at professional meetings, congresses, and other industry events. • Travel as required inside and outside of the U.S.

Requirements

Master’s degree or Bachelor’s degree and equivalent experience in a related field.
Minimum of 8 years of relevant experience including 3 years of management experience.
Knowledge of Good Clinical Practices and other regulations which apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly.
Familiarity with all aspects of the clinical trial process including, but not limited to protocol development, site selection/qualification, site initiation, monitoring, close-out, investigator meetings, DSMB/CEC, core lab management, and site compliance escalation.
Multidiscipline (at least 2 specialties) therapeutic knowledge.
Familiarity with medical device development process from pre-clinical to commercialization.
Understanding of the role of data management and biostatistics in the clinical trial process.
Understanding of the type and quality of data needed from a clinical trial and how it should be presented.
Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC personnel, and clients (and persuade them to do what is needed).
Ability to participate in and present during an FDA/notified body/regulatory inspection
Strong management and strategic business mindset and skills.
Ability to provide work direction, to include organizing, prioritizing, negotiating, communicating relevant project information and scheduling work assignments.
Ability to handle multiple priorities and issues, foster a cooperative work environment with high quality standards, and facilitate and manage effective meetings.

Responsibilities

Provides leadership and management direction to the Clinical Operations function.
Build effective working relationships with both internal and external partners; may act as a Strategic Partner with key clients.
Assists direct reports in developing effective strategies for communicating with and motivating project team members.
Intervenes and problem-solves with challenging clients as necessary.
Participate in resource planning to ensure project deliverables and client goals are met; ensure Associates are assigned clinical projects that are appropriate for their skills and training.
Accomplish clinical department financial objectives by forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
Confirm appropriate regulations and quality are applied within study and site management activities supported by NAMSA.
Work with staff to ensure client expectations are met including the schedule, cost and quality of our services. May lead projects, as needed, to meet key milestones, deliverables, or organizational goals.
Maintain qualified staff by recruiting, selecting, orienting, and training Associates and Managers.
Provide training and development opportunities to direct staff via personal development plans, quality oversight/assurance and/or career path planning.
May act as business owner for one or more NAMSA Clinical applications (e.g. CTMS, eTMF).
Lead continuous process improvement initiatives to drive efficiency and innovation within the Clinical organization.
Support review of proposals and provide input as needed.
Participates in meetings with prospective clients.
Identifies opportunities to bring in new projects/clients.
Offers opportunities to clients for expansion of Clinical services to be provided by NAMSA.
May represent the company and its capabilities at professional meetings, congresses, and other industry events.
Travel as required inside and outside of the U.S.