Clinical Operations Manager/Sr. Clinical Operations Manager

We are Growing! Let us support your career journey the Biorasi way.  Innovative, Collaborative, Dynamic and Evolving.  Capitalizing on your strengths while encouraging work-life balance.  Biorasi is an award-winning, customer-focused, full-service clinical research organization.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Your Role:

• Provide direct line management of Clinical Research Associates (CRAs)
• Mentor CRAs about job performance, training, and professional growth
• Manage Biorasi’s Monitor Evaluation Program

• Ensure global framework for CRA Oversight is documented.
• Track new hires or junior CRAs and ensure timely sign-off of oversight visits.
• Oversee process for routine oversight of CRAs as part of ongoing due diligence.

• Conduct an on-site or remote evaluation of CRAs.
• Serve as escalation point for any performance issues and ensure training is completed and documented where appropriate.
• Participate in career growth initiatives of Clinical Project Associates into CRA position.
• Assist project teams with resource allocation, reviewing site performance, providing feedback to CRAs, providing support in resolving issues.
• To lead and partake in regular team meetings/teleconferences.
• Take part in clinical branch or company-wide process improvement initiatives.
• Contribute to SOP review and updates as needed.
• May be involved with the selection and oversight of Clin Ops vendors.
• Ensure quality monitoring deliverables through monitoring report review, observational visits, identification of monitoring issues and compliance to study plans.
• Liaise with the QA department for audit inspection readiness tasks.
• Senior Clinical Operations Manager will support and mentor Central Monitoring team.
• Establish Central Monitoring guidelines and dashboards for Biorasi studies.
• Perform review of monitoring and quality metrics across all studies and provide status report to leadership.
• Liaise with Risk-Based Quality Management vendor.
• Support team in implementing and maintaining risk-based monitoring guidelines and practices.
• Senior COM will also mentor and support COMs globally.
• Comply with applicable national and international laws, regulations, including, but not limited to:
  • GxP (Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), and Good Manufacturing Practices (GMPs))
  • Company policies, standard operating procedures, operating guidelines, and other written instructions.

Your Profile:

• Bachelor’s degree in biomedical or related scientific discipline.
• Fluent in English (oral and written) and applicable local business language.
• Minimum 10 years of clinical research experience with a combination of clinical monitoring, study operations, and other relevant clinical research experience
• Ability to travel up to 15% depending on project needs.
• Good knowledge of medical terminology and expert proficiency level in clinical trial monitoring and management process.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements.
• Effective business skills for interactive situations with peers, sites, and clients.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.