Covance

Manager, Clinical Operations

Job Location(s) MY-Petaling Jaya
Job Number
2021-58665
Job Category
Clinical Operations Management
Position Type
Full-Time
Telecommute
No

Job Overview

Summary:
- Responsible for the supervision of assigned direct reports within Clinical Operations, Flexible Solutions
- Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves & Tugs"
- Responsible for appropriate management and resolution of performance issues
- 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
 
Responsibilities:
- Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented
- Escalate issues and follow them till proper resolution
- Ensures training record compliance with training matrix and ensures training records are up to date
- Provide input to relevant SOPs and standard plans/templates when applicable
- Assist with coordination and implementation of on-boarding of new direct reports ensuring training before study-related activities begins
- Hold staff accountable for issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
- Hold staff accountable for quality and compliance with project plan and adherence to contract obligations
- Coach staff to own effective Investigator relations and Investigator oversight when applicable
- Report status of assigned workload of direct reports and ensure allocation reports are updated
- Perform weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalate of outliers and assists management team for mitigation
- Adheres to expectations for monitoring and utilization forecasting
- Assist with staff recruitment through screening and interviewing
- Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
- Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
- Support the company/department processes (e.g. Quality Control Visits)
- Responsible for staff time management, PTO and salary reviews
- Might be requested to work in a client facing environment
- Perform other duties as required by Management

Education/Qualifications

- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting  will be considered
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal

Experience

- Minimum of 4 - 6 years of clinical research experience
- Good organizational and time management skills
- Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
- Excellent communication skills, oral and written.
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in team environment.
- Detail and process oriented
- Positive attitude and approach
- Interact with internal and external customers with high degree of professionalism and discretion
- Multi-tasking capability.
- Good computer skills with good working knowledge of a range of computer packages
- Ability to lead and develop junior staff
- Flexible and adaptable to a developing work environment

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