Covance

Country Lead Monitor

Job Location(s) KR-Seoul
Job Number
2021-78520
Job Category
Clinical Team Lead
Position Type
Full-Time
Telecommute
Yes

Job Overview

코반스 FSPx팀 에서 Country PM을 채용중입니다!
 
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.
 
특히, 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 있습니다.
 
We are hiring FSPx Country PM, the leader of the CRA team and is responsible for overseeing the CRA activities at the country level for the assigned studies. Key work relations are globally with study and clinical team members, and locally with other CLMs, CRAs, mediacl advisors, pharmacovigilance, regulatory affairs, legal and other functions. Further, external work relations are with investigators and site staff, study-related third party vendors, Thought Leaders including steering committee members and national leaders. In addition, the may be interactions with external committees and experts.
 
Responsibilities include, but are not limited to:
- Managing the cross-functional Country Feasibility team and process, involving the local Monitoring and Site Management and local Medical organizations. A reliable operational feasibility assessment is critical to the overall planning conduct of the global study. The CLM provides the GMSM country head (LHMSM or CCRM) with advice on operational feasibility of study design, timelines, cost, patient enrollment projections, and potential sites. This process must be consistent with the Study Concept provided by the GCL and requires significant collaboration on a local cross functional level.
- Leading cross-functional Site Selection Team to identify and determine interest and suitability of investigator's for participation in the assigned study.
- Developing Core Country Study Documents to initiate the study and ensures all study sites are initialed according to planned study timelines.
- Developing the Country Enrollment and Retention Plan. Managing and tracking country site initiation, enrollment, data cleaning activities to ensure they are consistent with country commitments and study timelines. Develops contingency plan to ensure site and country commitments are met.
- Managing and tracking the Study Country Level and site Budget, providing monthly country budget information to Local Controlling, LHMSM and Study Manager, as well as identifying budget/estimate issues and proactively developing a plan for resolving study finance issues. The CLM manages country budget and payments in appropriate tools.
- Ensuring all country CRAs are trained sufficiently for the trial. Identifies training gaps if additional training is required at country level works with the Study Lead Monitor to develop further training plans. Responsible for training all new CRAs for the study.
- Overseeing Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
- Proactively identifying potential or actual country related issues. Responsible for Country Level Corrective Action I Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution of issues that may impact the quality and compliance of the data, keeping SLM and LHMSM well informed of the status of the CAPAs
- Creating Country Monthly report and proactively notifying SLM and LHMSM of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.
- For outsourced studies: the CLM is the primary contact with the country CRO team and will support the CRO with regulatory and ethics submissions. The CLM will keep the Country Medical Director and local MSM teams informed of the status of the study. In addition, the CLM may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan
- The CLM may be assigned monitoring and site management responsibilities when required due to study workload.
Education/QualificationsEducational Requirements:
Must have 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
 
 
1. CORE COMPETENCIES:
- Customer focus
- Drive Results
- Plan & Align
- Manage Complexity
 
2. LEADERSHIP COMPETENCIES:
- Build Effective teams,
- Cultivate Innovation,
- Courage.
 
3. FUNCTIONAL COMPETENCIES:
- Deep knowledge of R&D processes and local &global regulations
- Project management skills
- Decision-making and issue resolution skills
- Cross-Functional collaboration
- Budget management
- Effective written and verbal English communication skills 
 
 

Education/Qualifications

Must have a Bachelor’s Degree (or equivalent) with 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.

Experience

Must have 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
 
 
1. CORE COMPETENCIES:
- Customer focus
- Drive Results
- Plan & Align
- Manage Complexity
 
2. LEADERSHIP COMPETENCIES:
- Build Effective teams,
- Cultivate Innovation,
- Courage.
 
3. FUNCTIONAL COMPETENCIES:
- Deep knowledge of R&D processes and local &global regulations
- Project management skills
- Decision-making and issue resolution skills
- Cross-Functional collaboration
- Budget management
- Effective written and verbal English communication skills 

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