Covance

Clinical Operations Manager (LM)

Job Location(s) KR-Seoul
Job Number
2020-50868
Job Category
Clinical Operations Management
Position Type
Full-Time
Telecommute
No

Job Overview

코반스 (Parent company: LabCorp)는 지속적인 성장과 체계적인 시스템 및 업무환경의 Global Top tier CRO로서, 매년 비지니스 확장과 직원수 증가로 현재 전세계 6만명 이상의 직원들이 근무하고 있습니다.
 
코반스 코리아는 Global CRO 중에서도 유일하게 전체 Spectrum, 즉 전 임상부터 Commercial 까지 Full service를 제공할 수 있는 유일한 CRO입니다. 한국은 2005년에 Legal entity 를 설립한 이후 1상부터 4상까지 다양한 indication 의 임상시험을 진행하고 있고, 정확하고 전문적인 성과로 더 크게 성장하고 있으며 직원들에게는 더 많은 커리어 기회를 제공하고 있습니다.
 
FSP team 의지속적인확장으로 저희 Line Manger 월드에 조인하실 보석같은 분을 찾고 있습니다.
 
Job Summary:
 
- Line Management role, largely will have CRAs or similar functions as direct reports in the newly realigned FSPx organization
- Responsible for the supervision of assigned direct reports within Clinical Flexible Solutions (FSPx)/CoSource and/or Global Site Services Staff
- 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
- Measure performance indicators for assigned staff
- Identify individual training needs and assist in the conduct of training and development efforts, regionally
- Conduct, report and follow-up on Monitor Quality Control Visits (MQC) for CRAs
- 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 
- GCP & Quality Oversight
 
Job Duties:
- 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 Monitor Quality Control 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 FSP staff
- Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
- Hold Clinical FSP/CoSource staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate
- 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
- Coach assigned staff to own effective Investigator relations and Investigator oversight at the local level 
- Productivity & Financial Management:
- Communicate status of assigned workload for metric reporting
- Perform weekly review of direct report billable hours and associated utiliation 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
- Adheres to global tools for monitoring and utilization forecasting
- Engage in Resource management activities for direct reports
- 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 Monitor Quality Control Visits to ensure costs are in alignment with regional budget
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 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
Preferred:
-  Masters or other advanced degree
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)
- 5+ 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 1 year 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
- Advanced planning and organizational skills
- Advanced oral, written and presentation skill

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 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
Preferred:
-  Masters or other advanced degree

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)
- 5+ 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 1 year 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
- Advanced planning and organizational skills
- Advanced oral, written and presentation skills

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