Manager Global Clinical Data Management

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:

•    Manage a group working with various clients and projects on clinical research data management and database development and validation in the medical device industry. Both paper-entry and electronic data capture systems are used in these activities.
•    Manage relationships with vendors providing database software to NAMSA Clinical.
•    Allocates staff for projects – hourly and project-based.
•    Hourly on-site projects:
        o    Is one of the principal spokespersons and the company’s primary interface with the customer
        o    Negotiates technical, schedule and quality issues with the customer and utilizes Executive Management support as needed.
o    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.

Qualifications & Technical Competencies:

•    Bachelor’s degree required; advanced degree is a plus, with a minimum of 3+ years of prior management experience of data management group preferred, and
•    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.

Working Conditions:

•    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•    While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kgs). Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
•    Extensive use of a computer keyboard.
•    Ability and flexibility to manage OUS NAMSA Associates and clients, and adapt to different time zones.
 

NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.