Covance

Manager, Clinical Operations - Malaysia

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

Job Overview

Are you ready to discover you next career at Covance?
 
A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient’s lives. Joining Covance will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting.
 
Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
 
As an Associate Clinical Operations Manager you will be accountable for the execution and oversight of local operational clinical trial activities and have ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.
 
 
Summary:
- Responsible for the supervision of assigned direct reports within Clinical Operations, Flexible Solutions (CRAs, SSU Specialists and Clinical Project Managers)
- 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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