Clinical Operations Manager/Sr. Clinical Operations Manager

10+ years

Not Disclosed

Mumbai

10 Sept. 30, 2024

Job Description

Job Type: Full Time Education: B.Sc/ M.Sc/ B.E/ M.E./ B.Com/ M.Com/ BBA/ MBA/B.Tech/ M.Tech/ All Graduates 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

Join Us at Biorasi – Where Your Career Can Thrive!

At Biorasi, we are growing, and we invite you to support your career journey the Biorasi way: innovative, collaborative, dynamic, and ever-evolving. We capitalize on your strengths while promoting a healthy work-life balance. As an award-winning, customer-focused, full-service clinical research organization, we are passionate about advancing clinical research.

We are looking for top performers—both clinical trial veterans and industry newcomers—who share our enthusiasm for clinical research. Here’s your chance to become an integral part of a global company in the expanding clinical research industry.

Your Role:

Direct Management: Provide leadership and direct line management for Clinical Research Associates (CRAs).
Mentorship: Guide CRAs in job performance, training, and professional development.
Monitor Evaluation: Manage Biorasi’s Monitor Evaluation Program and ensure global CRA oversight frameworks are documented.
Oversight: Track new hires and junior CRAs, ensuring timely completion of oversight visits.
Performance Management: Address performance issues, ensuring training is completed and documented as needed.
Career Growth: Participate in initiatives to promote Clinical Project Associates into CRA positions.
Support Teams: Assist project teams with resource allocation, site performance reviews, and issue resolution.
Team Engagement: Lead and participate in regular team meetings and teleconferences.
Process Improvement: Contribute to clinical branch or company-wide process improvement initiatives and assist in SOP reviews and updates.
Vendor Oversight: Engage in the selection and oversight of Clinical Operations vendors.
Quality Monitoring: Ensure quality deliverables through monitoring report reviews, observational visits, and compliance checks.
Audit Readiness: Collaborate with the QA department to prepare for audit inspections.
Central Monitoring: Establish guidelines and dashboards for Central Monitoring in Biorasi studies and support the implementation of risk-based monitoring practices.

Your Profile:

Education: Bachelor’s degree in a biomedical or related scientific discipline.
Language Proficiency: Fluent in English (oral and written) and applicable local business language.
Experience: Minimum of 10 years in clinical research, encompassing clinical monitoring, study operations, and relevant research experience.
Travel: Ability to travel up to 15% based on project needs.
Clinical Knowledge: Strong understanding of medical terminology and proficiency in clinical trial monitoring and management processes.
Regulatory Awareness: In-depth knowledge of ICH GCP and relevant regulatory requirements.

Biorasi is committed to fostering a diverse environment and proudly stands as an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We also uphold compliance with fair employment practices related to citizenship and immigration status.

Join us and be part of a team that is dedicated to making a difference in the world of clinical research!

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Clinical Operations Manager/Sr. Clinical Operations Manager

Job Description

Join Us at Biorasi – Where Your Career Can Thrive!

Your Role:

Your Profile:

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