Manager Clinical Affairs Jobs

Kelly® Science & Clinical is seeking a Clinical Affairs Manager position with one of our clients, a high-complexity CLIA lab in Vancouver, WA that is developing novel clinical diagnostics based on at-home collection kits. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $100,000-140,000

Benefits: New employees are eligible for the following benefits effective on the 1st day of the month following a 30-day waiting period.

• Education Reimbursement
• 4 weeks total of sick and vacation paid time off; and 7 paid holidays + 1 floating holiday for employees hired before June 30, then awarded every Jan 1.
• 401k Plan with Company Match
• Medical, dental, and vision benefits
• Company-paid life insurance and disability benefits, and EAP

Overview

To assist in the management of clinical research study(ies) with the express intention of submitting to regulatory bodies and the FDA for 510K clearances. The position will be responsible for managing the clinical trial directors and Clinic Research Organizations of individual studies. The position will need to manage clinical study(ies) personnel and resources to ensure that the studies designed by the research team are operating within the protocol and reaching critical milestones. Knowledge of IVD CFR codes and operating within FDA regulatory rulings is required.

Responsibilities

• Manage selection of clinical sites and study protocol training.
• Initiate, develop, and maintain connections among physicians/investigators, and other applicable medical professionals including Contract Research Organizations (CROs)
• Oversee clinical data collection, trial monitoring, and auditing according to GCP guidelines and study SOPs.
• Ensure that all safety reporting during and after the clinical trial is complete.
• Maintain market surveillance of published literature and clinical results in products across all relevant competing devices and indications for strategic purposes for use in regulatory submissions present and future.
• Represent clinical trial management during clinical trial case reviews with physicians, clinic/hospital staff, and coordinators.
• Prepare required submission documentation.
• Manage multiple clinical trials/registries from initiation through completion.
• Ensure clinical trial results are collected, interpreted, and documented clearly for regulatory submission.
• Support data analyses and publication/presentation generation
• Audit clinic/CROs for compliance to study/ regulatory needs

Qualifications

• Expert knowledge and comprehensive understanding of applicable GCP, ICH and FDA, and other internal regulations.
• Advanced computer skills including spreadsheet generation, word processing, database management, PowerPoint, and other necessary applications.
• A bachelor’s degree in a scientific discipline; an advanced degree is preferred. Candidates with professional certifications relevant to the studies and with exceptional experience will be considered.
• Excellent interpersonal, written/verbal communication, and organizational skills.
• Ability to self-motivate and prioritize required tasks to meet deadlines.
• Experience with CTMS systems
• Certified Clinical Research Professional (CCRP) or equivalent certification
• Experience with assessing potential candidates for CSC applicants and other study support personnel.
• 6+ Years of clinical project(s) management experience which should include at least 3+ years of directly managing a clinical study research team.
• Ability to pivot between multiple projects easily, quickly, and accurately.
• Ability to provide strategic input into the management of study procedures and staffing personnel.

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