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Clinical Operations Manager/Sr. Clinical Operations Manager

10+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary

Biorasi, a fast-growing, full-service clinical research organization (CRO), is looking for a Senior Clinical Operations Manager (Senior COM) to join their dynamic team. Biorasi is seeking experienced clinical trial professionals who are passionate about clinical research, and who thrive in a collaborative, evolving, and fast-paced environment. As part of the growing global team, you will play a pivotal role in overseeing Clinical Research Associates (CRAs) and ensuring the successful execution of clinical trials, all while supporting the company's mission to deliver new therapies to patients.

Your Role

As a Senior Clinical Operations Manager, you will be responsible for the management and mentorship of Clinical Research Associates (CRAs), overseeing clinical trial monitoring processes, and ensuring compliance with industry standards. Your role will include the following key responsibilities:

  • CRA Management: Provide direct line management of CRAs, mentor them on performance, training, and career development.
  • Monitoring Oversight: Oversee Biorasi’s Monitor Evaluation Program and ensure proper documentation of CRA oversight. Track new hires or junior CRAs and ensure timely sign-off on oversight visits.
  • Escalation Point: Serve as the escalation point for any performance-related issues with CRAs and ensure that appropriate training is completed.
  • Resource and Site Management: Support project teams in resource allocation, site performance evaluation, and feedback provision. Assist in resolving monitoring-related issues.
  • Process Improvement: Lead or participate in process improvement initiatives within the clinical operations department and assist with the development and updates of Standard Operating Procedures (SOPs).
  • Central Monitoring: Establish and review monitoring guidelines and dashboards, support the implementation of risk-based monitoring practices, and mentor Central Monitoring teams globally.
  • Quality Monitoring: Ensure the quality of monitoring deliverables through regular report reviews, observational visits, and ensuring compliance with study plans.
  • Audit Support: Liaise with the QA department for audit inspection readiness tasks.
  • Vendor Oversight: Participate in the selection and oversight of Clinical Operations vendors as needed.
  • Regulatory Compliance: Ensure all activities comply with GxP standards (GCP, GLP, GMP), company policies, and international regulatory requirements.

Qualifications

  • Education: Bachelor’s degree in biomedical or a related scientific discipline.
  • Experience:
    • Minimum of 10 years in clinical research, with a combination of clinical monitoring, study operations, and other relevant clinical research experience.
    • Expert proficiency in clinical trial monitoring and management.
  • Skills:
    • Strong understanding of ICH GCP guidelines and worldwide applicable regulatory requirements.
    • Effective interpersonal skills to interact with peers, sites, and clients.
    • Ability to manage and mentor a global team of Clinical Research Associates (CRAs).
    • Experience in risk-based monitoring and central monitoring.
  • Travel: Ability to travel up to 15%, depending on project needs.
  • Language: Fluent in English, both oral and written, and applicable local business language.

Compensation and Benefits

Biorasi offers a comprehensive benefits package, including:

  • Work-Life Balance: Flexible work hours with opportunities for remote work.
  • Paid Time Off (PTO) and paid holidays.
  • Employee Bonus Programs.
  • Career Development: Opportunities for continued training and career growth.
  • Health and Well-being: Competitive health benefits for employees and their families.

Why Biorasi?

Biorasi values a culture of innovation, collaboration, and continuous development. As a growing global organization, Biorasi is committed to creating a dynamic, diverse, and inclusive work environment where all employees can thrive. The company emphasizes career development, work-life balance, and fostering a supportive, evolving workplace.

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

What to Expect Next

If you meet the qualifications, a Biorasi team member will review your application and reach out to you with details on next steps. This may include an interview process and further discussions on your experience and fit for the role.