Clinical Affairs Manager

Responsible for the clinical aspects of medical device projects at all product life cycle, clinical affairs activities, and special projects

Responsibilities:

• Select Clinical consultants and Clinical Research Organizations (CROs) and manage their contracts
• Recruit, hire, train, manage Clinical staff and their career development (Future)
• Prepare and track Clinical budget
• Allocate resources and budgets to various department projects and oversee their progress
• Participate in preparation of Clinical 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 the relevant regulatory authorities and Institutional Review Boards (IRBs) or Ethics Committees (ECs)
• Interact with Investigators and IRBs on financial and compliance issues
• 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 the relevant regulations, department SOPs, and corporate requirements
• Develop and manage the process for clinical regulatory document preparation and submissions for clinical studies (IDE submissions, IRB/EC submissions, etc.)
• Author, oversee and/or review Clinical Evaluation Plans, Clinical Evaluation reports, Post Market Clinical Follow Up plans and reports, SSCPs and any other clinical documentation required for continued CE Marking.
• Ability and willingness to travel abroad (10%-20%)

Knowledge, Skills, and Abilities

• Bachelor’s degree in science or health-related field, Master
• Degree preferred
• ACRP or SoCRA certification preferred
• 8+ years related experience
• Experience in the medical device or pharmaceutical industries is required
• Strong knowledge of FDA regulations and International Conference Harmonization (ICH) and Good Clinical Practices (GCPs) guidelines
• Demonstrated experience with European clinical study requirements and CE marking, EUMDD / MDR, MEDDEV 2.7.1 Revision 4, ISO 14155 and other relevant regulation
• Regulatory/Clinical documents writing
• Ability to independently lead clinical research
• High interpersonal skills
• Fluent in English
• Excellent teamwork skills
• Strategic thinking
• Presentation skills
• Leadership skills

• Bachelor’s degree in science or health-related field
• ACRP or SoCRA certification preferred
• 8+ years related experience
• Experience in the medical device or pharmaceutical industries is required
• Leadership or people management experience is an asset
• Strong knowledge of FDA regulations and International Conference Harmonization (ICH) and Good Clinical Practices (GCPs) guidelines
• Demonstrated experience with European clinical study requirements and CE marking, EUMDD / MDR, MEDDEV 2.7.1 Revision 4, ISO 14155 and other relevant regulations

All your information will be kept confidential according to EEO guidelines.

Legal authorization to work in the United States is required.

This job may be subject to a background check, consistent with State and local law, including where applicable the Los Angeles Fair Chance Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act.