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Senior Manager Clinical Operations

 Covance India Pharmaceutical services pvt ltd.

  • 5 - 10 years
  • Mumbai
  • Applicants: 1
  • Views: 70
  • Posted: 09 01 2020
  • Full Time

Job Details

Experience: 5 - 10 years

Qualification: Any graduate(Any)

Salary Offered: Not Disclosed

Functional Area: Pharmaceutical / Biotechnology

Industry: Pharmaceutical

Role: Clinical Research Scientist

Job Location: Mumbai

Gender: Any Gender

Number of Vacancy: 1

Job Description

Job Overview:

  1. CP 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
  1. 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:

Required:

  • 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 five (5) years supervisory experience in a health care or clinical research setting and
    • Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO

Skills Required

clinical operations
Clinical Research
pharma
Project Management
quality compliance

Key Requirements

Job Overview:

  1. CP 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
  1. 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:

Required:

  • 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 five (5) years supervisory experience in a health care or clinical research setting and
    • Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO

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ABOUT COMPANY

If You Need An Insightful Partner With A Local Presence In India, You Will Benefit From Covance's Experience And Cross-functional Expertise. Since 2007, We’ve Worked In India To Meet Unique Clinical Trial Requirements And Provide Access To Comprehensive Drug Development Solutions. As Your Collaborator, We Can Help Transform Your Results.