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8700BR - Manager, Clinical Research
The Barron/carlington Group
Gabriel Gonzalez
US-New Jersey
8700BR - Manager, Clinical Research
Full Time
5
8700BR - Manager, Clinical Research LOCATION: New Jersey (07430) . (Relocation Available)
This is a retainer based executive search, our client a global leader in medical technology that consist of orthopedic products in over 120 countries. We are searching for a Manager, Clinical Research based in New Jersey. If you are interested please send your resume and I will reply ASAP.
POSTION DETAILS
Salary Range: $110K to 135K plus a $15,000 bonus-We may be prepared to go higher on the base salary
for "Star" Candidate.
Best Industry : Bio-Tech , Clinical Affairs , Clinical Research Organization , Health Research , Medical , Medical Device
Best Department: Clinical Affairs , Research & Development
Reports to: Director, Clinical Research
NO SPONSORSHIP AVAILABLE
Relocation Available
Up to 25% Travel
4 year degree
5-10 years experience
Overall management responsibility for IDE and post-marketing clinical trials. Manage clinical personnel and participate in budget and resource allocation to various projects.
Ensure department SOPs comply with regulations and staff adheres to these SOPs.
Manage proper collection, analysis and presentation of clinical data.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Recruit, hire, train, manage Clinical Research staff and their career development
Select Clinical Research consultants and Clinical Research Organizations (CROs) and manage their contracts
Prepare and track Clinical Research budget
Allocate resources and budgets to various department projects and oversee their progress
Participate in preparation of Clinical Research operating plans and objectives in alignment with company and department strategies
Supervise the implementation of clinical programs and track their progress
Oversee the planning of new clinical programs and the development of clinical protocols
Review and approve submissions of protocols and reports to FDA and Institutional Review Boards (IRBs)
Interact with Investigators and IRBs on financial and compliance issues
Collaborate with Clinical Operations Manager to establish effective and efficient intra-departmental processes
Oversee the proper collection, analysis and presentation of clinical data
Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases
Oversee development and maintenance of department SOPs
Assure compliance of department activities to FDA regulations, department SOPs, and other regulations
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics' continuous improvement initiatives
QUALIFICATIONS:
5+ years experience in conducting Investigational Device Exemption (IDE) and post-marketing clinical trials of medical devices
Previous personnel management experience required
Experience in submission of IDEs, Post Marketing Applications (PMAs) to the Food and Drug Administration (FDA) agency, as well as meetings with FDA
Experience developing and maintaining department Standard Operational Procedures (SOPs)
Applied knowledge of FDA regulations, International Conference Harmonization (ICH), and Good Clinical Practices (GCPs) guidelines
Demonstrated leadership skills
Demonstrated experience working in and fostering a team-based work environment preferred
Applied knowledge of personal computer systems and desktop office applications
EDUCATION:
Bachelor’s Degree in science or health-related field required; advanced degree preferred.
CANDIDATE MUST HAVE:
5+ years experience in conducting Investigational Device Exemption (IDE) and post-marketing clinical trials of medical devices
Experience in submission of IDEs, Post Marketing Applications (PMAs) to the Food and Drug Administration (FDA) agency, as well as meetings with FDA
Bachelor’s Degree in science or health-related field required; advanced degree preferred.
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