Clinical Operations Manager (LM)

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 의 지속적인 확장으로 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 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