7272 Garden Grove, CA 92841
Senior Clinical Affairs Specialist
General Job Description:
The Senior Clinical Affairs Specialist has a leading role in the planning, coordination, and execution of Hycor’s clinical performance studies. She/he must have excellent verbal and written communication skills, have the ability to motivate and manage teams and have in vitro diagnostic (IVD) technical clinical research operational skills. The Senior Clinical Affairs Specialist must have an excellent working knowledge of applicable regulations and guidelines.
The Senior Clinical Affairs Specialist, through individual contribution and with the support of his/her team will:
Manage the overall day-to-day operations of multiple IVD clinical performance studies.
Coordinate and prepare Clinical Investigational Plans/Protocols and supporting clinical study materials.
Develop and manage clinical study plans and budgets and is responsible for monitoring and achieving targets.
Conducts routine and ad hoc meetings and written updates, with clinical affairs, cross-functional teams and company leadership to drive projects and share key information.
Manage study budgets and accounting.
Ensure effective and efficient study initiation through procedures and best practices in site qualification and development.
Ensure timely trial progress including site management for effective subject recruitment and protocol compliance.
Ensure clinical data integrity is maintained through appropriate oversight of staff, sites and monitoring practices through all phases of the studies.
Manage medical monitoring processes, core-labs, and other contracted study vendors. Liaise with study committees, such as Steering and Data Monitoring Committees, as needed.
Have a detailed knowledge of GCPs, ISO 14155, and EN 13612.
Assist in preparation of Clinical Reports for regulatory submissions, including 510(k)s, international pre-market submissions, and Clinical Reports for other data dissemination activities.
Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff, including qualification, selection, budget, and work-scope negotiations and oversight.
Support and establish procedures and work instructions for key clinical research activities to assure compliance and efficient study conduct.
Coordinate and prepare clinical study reports and summaries on clinical trial results for internal review by other departments and senior staff. When appropriate, supports the preparation of manuscripts for publication of trial results in professional journals.
Create, manage and oversee the maintenance of all trial master files, at company and at investigational sites.
Be prepared for and manage on-site or remote regulatory audits by company or regulatory agency representatives.
Support company goals and objectives, policies and procedures, performance management programs, and applicable national and local regulations.
Act as core team member on project teams to provide clinical trial guidance and strategic clinical trial planning in support of new product development and existing product support.
Participate in and review risk management activities/documents and ensure compliance with ISO 14971.
Work directly with medical affairs and complaint handling staff to facilitate accurate adverse event reporting.
Maintain a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity.
Support commercialization activities for product lines globally according to local and regional regulatory and quality requirements.
Lead projects of various scope and size, as assigned.
Be experienced in influencing other functions and managing in a matrix environment.
Perform other duties, as required or assigned.
Have strong planning, organizational, and communication skills.
Have computer knowledge consisting of email, Word, Excel, Project, Visio, Adobe Acrobat Professional, and other basic skills.
Have excellent judgment, a positive driver attitude, be customer oriented, and a team player.
Education: Bachelor Degree in Science or Medical Technology
Licenses/Certifications: Clinical Research Associate Certification (CCRA and/or CCRP) is a plus.
Skills/Abilities: Ability to work independently. Excellent oral, written, organizational, and analytical skills. Solid understanding of IVD products, immunoassays, IVD instruments and software, and general clinical lab materials and supplies. Ability to represent the clinical department in frequent inter-organizational meetings. Ability to perform work with minimal direction and supervision. Ability to provide solutions to difficult technical issues associated with specific projects.
Minimum of 7 years of experience in diagnostics, life science, or medical devices with a minimum of 5 years in clinical research and 2 years of IVD specific clinical research. IVD assay development experience is a plus.
Demonstrated ability to successfully manage and execute clinical studies with IVDs to meet business goals using standard best practices and compliance norms.
Demonstrated ability to supervise CRAs and Monitors, and work successfully on cross-functional teams.
Detailed knowledge of GCPs, ISO 14155, and EN 13612.
Working knowledge of IDEs, 510(k)s, and IVDD/IVDR.
Working knowledge of ISO 13485, Quality System Regulation, and relevant international standards.
Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971.
Proven track record of maintaining clinical knowledge and skills by participating in industry conferences/seminars.
Must be available and willing to work flexible schedules, as needed.
Must be able to travel, up to 30%
Prior experience with GCP and internal audits.
Strong working knowledge of problem solving and statistical methods, as applied to clinical studies.
Good understanding of medical treatment aspects related to IVDs for allergies and auto-immune diseases.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or regulations.
Ability to independently determine and develop approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives
Application Information & Contact (How to Apply)
To apply, please email resume to LCristobal@hycorbiomedical.com