Senior Manager Global Clinical Data Management
NAMSA pioneered the industry, NAMSA 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 whose:
- Mission is to make a scientific contribution to every medical device in the world.
- Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
- Values have stood the test of time.
- Above all else, conduct ourselves with integrity
Job Description:
- Plans, manages, and coordinates activities of the Global Data Management department to include Data Management and/or Database Development professionals.
- Develops and sets goals and expectations for Global Data Management department in alignment with Global Clinical Sciences.
- Ensures the team follows appropriate regulations and quality systems are applied in the performance and documentation of deliverables.
- Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans and/or career path planning.
- Works collaboratively with cross-functional teams to increase company efficiencies.
- Serve as the point of escalation for department or client risks/issues.
- Identifies and guides process improvement projects to enhance efficiencies, quality, and profitability.
- Work cooperatively and collaboratively with Project Management and cross-functional colleagues to deliver projects with high-quality and demonstrated excellence in customer service.
- 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.
- Model and instill exceptional customer service across the team by acting collaboratively, being responsive to client requests, communicate thoughtfully, and maintain high standards of quality.
- Participate in meetings with prospective clients.
- Provide scope of project and relevant information to support the creation of proposals.
- Identify opportunities to bring in new clients and/or projects.
- Offer opportunities to clients for expansion of cross-functional services to be provided by NAMSA.
- Contributes to Marketing and Sales initiatives focused on Global Data Management department in particular, including presentations, bid defense meetings, and proposal development.
- Other duties as assigned.
Qualifications & Technical Competencies:
- Minimum Bachelor’s degree, preferably in scientific discipline, life sciences, computer science, or mathematics required. Advanced degree in relevant field preferred.
- Minimum of 10 years of relevant experience, including 2 years of management experience
- Strong leadership and business acumen skills
- Strong knowledge of ICH/GCP, FDA and EU guidelines and regulations, particularly those relevant to Clinical Data Management
- Strong customer-focus and cultural fit with NAMSA values
- Fluency in English and local language, if different, required.
- Strong knowledge of medical research and product development business environment, particularly in the areas of medical device clinical studies and associated regulations and standards.
- Experience with data management activities and database development/validation activities and processes
- Familiarity with multiple statistical software and electronic data capture (EDC) systems.
- Financial acumen, including the ability to understand a budget and departmental financial results.
- 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 communication.
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.
- Travel up to approximately 20% of time