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 : Associate Clinical Operations Manager
Job Description:
- Responsible for the supervision of assigned direct reports within Clinical Operations, CoSource and/or Global Site Services Staff
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment
- Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business
- Ensures training record compliance with training matrix and ensures training records are up to date
- Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
- Hold Clinical Operations and CoSource staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate
- 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
- Hold CoSource staff accountable for quality and compliance with client SOPs and adherence to Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
- Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation
- Escalates available workload hours, in context of project allocation, supply and demand, to management team
Candidate Profile:
1) 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)
2) In lieu of this required educational background the following relevant work history may be considered:
- Minimum of two (2) years supervisory experience in a health care or clinical research setting and
- Minimum of six (6) years relevant clinical research experience in a pharmaceutical company/CRO
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Experience Required:
1) 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 four (4) 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
2) Relevant supervisory experience
- Some experience as a Line Manager or Project Manager preferred
- 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
- Advanced planning and organizational skills
- Advanced oral, written and presentation skills
Additional Information:
Experience : 2 years
Qualification : degree in life science
Location : Mumbai India
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Clinical Operations
Last date : 25th October, 2017
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