Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Senior Clinical Operation Manager
Job Description
A. GCP and Quality Oversight:
• Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented
• Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits
• Ensures training record compliance with training matrix and ensures training records are up to date
• Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff
• Assist with coordination and implementation of on-boarding new direct reports ensuring GCP training before monitoring begins
• Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
• Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
• Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level
B. Productivity and Financial Management:
• Communicate status of assigned workload for metric reporting
• Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers and assists management team for mitigation
• Escalates available workload hours, in context of project allocation, supply and demand, to management team
• Adheres to global tools for monitoring and utilization forecasting
• Engage in Resource management activities for direct reports or across a project team
• Assist with staff recruitment through screening and interviewing
• Financial authority in accordance with current signature approval matrix
• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
• Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma
• Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
• Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget
Education/Qualifications
• University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• In lieu of this required educational background the following relevant work history may be considered:
- Minimum of three (3) years supervisory experience in a health care or clinical research setting and
- Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO
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Experience
• Relevant clinical research experience in a pharmaceutical company or CRO
- Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
- Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO
- Thorough knowledge of drug development process
- Thorough knowledge of relevant SOPs, ICH, and GCP guidelines
• Relevant supervisory experience
- Minimum of 3 years as a Line Manager or Project Manager required
- Demonstrated ability to lead by example and to encourage team members to seek solutions
- Proven interpersonal skills
- Demonstrated ability to successfully participate as a member of a project team
- Demonstrated ability to successfully manage multiple competing priorities
- Excellent planning and organizational skills
- Excellent oral, written and presentation skills
Additional Information:
Requisition ID: 61100BR
Experience: 3-7 years
Location: India
Education: degree in life science
Industry Type: Pharma/ Biotech/Clinical Research
Job Type: Clinical Research
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