Clinical Manager (Medical Device): National Search Associates

Responsible for coordination and development for all clinical studies conducted for clinical feasibility, efficacy, safety, performance and/or clinical claims in accordance with global regulatory requirements and company policy and procedures. Act as an advisor, facilitator and mentor to department members and become actively involved as required to meet schedules and resolve conflicts.

Essential Functions:

1. Direct the design, management, and evaluation of clinical studies.
2. Manage and coordinate the activities of the Clinical Affairs group with responsibility for achieving objectives on time and within budget.
3. Identify, qualify, select, and manage clinical investigators, and disqualify non-compliant investigators/sites.
4. Participates in training and developmental programs for Clinical Affairs staff, as appropriate.
5. Coordination of the Medical Safety Board.
6. Assist in preparation of regulatory submissions, including IDEs, PMAs, 510Ks, and foreign filings.
7. Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff.
8. Clinical monitoring duties as needed including: study site monitoring and tracking, working with clinicians to ensure adherence to protocol, FDA and GCP guidelines, initiations and close out visits, review case report forms for completeness, legibility and conformity to available source.
9. Coordinate and assist with clinical monitoring duties of Clinical Research Associates as needed.
10. Coordinate and assist with database creation and management as needed.
11. Analyzes data and prepares technical reports on clinical trial results for internal review by other departments and senior staff. When appropriate, prepares manuscripts for publication of trial results in refereed journals.
12. Engage in analysis of current medical practice and proposed new products or indication for use through on-site visits to contracted institutions or external research facilities, attending conferences and by on-going review of published technical literature.
13. Performs other related duties and assignments as required.
14. Work closely with subordinates and other managers to understand and support their needs.
15. Direct, lead and develop assigned team to continually improve performance, evaluate strengths and developmental needs; provide appropriate feedback, coaching and mentoring to ensure high levels of performance within the reporting function.
16. Provide day-to-day guidance and oversight of managers and employees; attract and select a top team, train, supervise, motivate, and develop managers and employees; oversees establishment of effective schedules and workflow; actively work to promote and recognize performance.
17. Assign objectives and monitor quality of work; assure management and employees conform to organizational policies and procedures and government regulations.
18. Keep up to date on overall activities of the team; develop employees; identify problem areas and take corrective actions when needed to address performance or disciplinary issues.
19. Seek feedback from managers and employees, analyze results; continually develop plans for improvement; ensure communication and information flow throughout the reporting organization and across functional lines; provide reporting employees and managers with current, pertinent, job-related information; and foster positive interaction among team members.
20. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, performance management programs, and FDA regulations.
21. Actively and proactively support implementation of Affirmative Action and EEO goals.

Job Requirements:

Education and Training

• BA/BS in life science or equivalent combination of education and experience.

Required Experience

• A minimum of 7 years of related experience.
• Established success in management with demonstrated ability to supervise and motivate teams to reach objectives.