Clinical Research Associates Manager (remote)

Company: Bongene Search
Location: Seattle
Posted on: January 15, 2022

Job Description:

Bongene Search is a biotech, pharmaceutical, and medical staffing agency that believes talent lies at the heart of all great companies. As such, the team at Bongene Search is dedicated to helping our clients around the globe create the most talented team of biopharma professionals. Whether it is a large publicly-traded company or a biotech start-up, our medical, pharmaceutical, and biotech recruiting agency will create a tailor-made search process that delivers the perfect fit for the role. We represent the following opportunity from our client.

Clinical Research Associates Manager

RESPONSIBILITIES:
Manage direct reports and conduct ongoing review of Clinical Research Associate staff and project assignments to ensure adequate support to meet Divisional Clinical Research goals across multiple projects
Responsible for the training, growth, development, and performance management of CRAs in collaboration with the Clinical Affairs Research Teams
Design, develop, execute and maintain the Clinical Affairs new CRA hire training program. Develop and/or update related SOPs and documents as appropriate
Conduct ongoing review of CRA workforce and skills distribution to ensure adequate resources are available to meet departmental goals
Ensure that clinical monitoring activities of the CRAs' assigned teams are performed to the teams' satisfaction, ensuring timely quality deliverables, in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements
Responsible for ensuring compliance with applicable Corporate and Divisional Policies and Procedures
Implement and maintain the effectiveness of the Quality System
Review Clinical Group processes and documents and identify/implement any improvements
Provide subject matter expertise across in-house and external clinical activities

QUALIFICATIONS:
Required
Knowledge of regulations and standards affecting IVDs (In Vitro Diagnostics) and Biologics
Minimum Bachelor's Degree in a discipline appropriate to a Clinical Research, Scientific, Medical, Technical or related field
8+ years of experience as a CRA, direct Clinical Research experience, or an equivalent combination of education and work experience
Proven ability/experience training CRAs and sites on relevant Clinical topics
Experience directly supporting and training for clinical research or similar experience in a medical/scientific area
Experience managing and training clinical research professionals within a team as well as in cross-functional development settings

Preferred
Certification from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA)
Medical Device/Diagnostics Clinical experience, understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage
Experience managing other clinical operations positions
Willing and able to travel up to 10% of the time

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