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Clinical Trial Manager

8+ 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, an award-winning, customer-focused, full-service clinical research organization (CRO), is seeking experienced Clinical Research professionals to join their growing global team. Biorasi is looking for individuals passionate about clinical research and dedicated to helping drive new therapies to patients. As part of a dynamic and innovative team, you will play a key role in managing the clinical aspects of clinical trials, optimizing study execution, and leading a high-performing clinical team.

Your Role

As a Clinical Operations Manager, you will be responsible for managing and supporting all clinical aspects of a study, including site management, study start-up, document and supply management, and ensuring compliance with international standards. Key responsibilities include:

  • Study Management:

    • Lead or support all clinical aspects of study execution.
    • Manage clinical study timelines, metrics, and project debriefings.
    • Provide study-specific training and leadership to the clinical team.
    • Plan and execute study-related meetings, such as Study Management Meetings and Investigator Meetings.
  • Site Management:

    • Track and manage subject recruitment at all study sites.
    • Oversee or support the management of monitoring visits and review of monitoring reports.
    • Monitor study/site performance, identify issues, and escalate infringements, protocol deviations, or misconduct.
  • Study Start-Up:

    • Optimize trial execution by contributing to site selection and resource allocation.
    • Work with the study team to design clinical protocols and create study-related documents.
    • Prepare or review essential documents for study conduct and management.
  • Document and Supplies Management:

    • Oversee the collection, review, and filing of site essential documents.
    • Coordinate clinical study supplies, ensuring accurate tracking using systems such as IWRS, EDC, or CTMS.
  • Compliance:

    • Ensure adherence to international GCP guidelines, SOPs, and study protocols.
    • Participate in quality assurance activities and support the resolution of audit findings.
  • Staff Management:

    • Support the Clinical Management Team and provide guidance to junior clinical staff.
    • Participate in the selection of sites and countries, developing relationships with investigators and site staff.
  • Cross-functional Collaboration:

    • Regularly interact with internal and external stakeholders (regulatory affairs, vendors, investigators, etc.).
    • Participate in team meetings, client presentations, and investigator meetings as needed.
  • Communication and Reporting:

    • Communicate out-of-scope issues to senior clinical management or project management teams promptly.

Qualifications

  • Education: Bachelor’s degree in biomedical sciences or a related scientific discipline.
  • Experience:
    • Minimum of 8 years of clinical research experience, with expertise in clinical monitoring, study operations, and other clinical research areas.
    • Strong knowledge of medical terminology and expert proficiency in clinical trial monitoring and management processes.
    • Solid understanding of ICH GCP and other applicable regulatory requirements.
  • Skills:
    • Excellent organizational, multi-tasking, and time management skills.
    • Strong verbal, written communication, and presentation skills.
    • Proven ability to document study conduct and management effectively.
    • Effective business skills for interacting with peers, sites, and clients.

Compensation and Benefits

Biorasi offers a comprehensive benefits package, including:

  • Work-Life Balance: Half-day Fridays and generous paid time off (vacation, holidays, sick days).
  • Health Benefits: Medical, dental, vision, life insurance, short-term and long-term disability.
  • Financial Benefits: Company matching 401(k), employee bonus programs, and tuition reimbursement.
  • Career Development: Opportunities for growth, training, and development.

Why Biorasi?

At Biorasi, we value innovation, collaboration, and work-life balance. Join a dynamic team where you will have the opportunity to work in a global, fast-paced environment that drives the advancement of new therapies for patients. Biorasi is committed to diversity and inclusion, providing equal opportunities to all qualified applicants.

What to Expect Next

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

Apply Now

To apply, visit our website at Biorasi Careers or email your resume to careers@biorasi.com.