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Open Position

Open Position

항암전문기업 Country Study Manager 1년 계약직 채용합니다.(대리~과장)

  • 2021-03-03 17:18:00
  • 1.223.120.93

 

Position Purpose:

The Country Study Manager (CSM)/  Associate Country Study Manager (ACSM) provides leadership and local strategic planning and organization skills to ensure the effective and efficient delivery of operational aspects of one or more studies through all phases of study management (preparation, conduct, close-out), in accordance with the appropriate quality standards including ICH/GCP/GPP standards, SOPs, local operating guidelines and local requirements, as applicable.

• The CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for local study team.

• Main job scope: IIS (Investigator-Initiated Study), PMS (Postmarketing Surveillance), Sponsor-Initiated Trial (Korea only), PDMA (Global Medical Affairs) studies

Main Responsibilities and Accountabilities:

Throughout the Study Lifetime:

• Has full accountability for all assigned studies at country level including adherence to quality, timelines and budget.

• Leads local study teams, represents Country Clinical Operation.

• Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed.

• Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, cost) and interfaces regularly with local Vendor Manager and CRO Management regarding feedback on CRO staff performance.

• Collaborates in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up.

• Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost)

• Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.

Study Preparation Phase:

• Leads and participates in the preparation phase of the study (feasibility, site selection, initiation) ensuring all other roles that support these activities both within Clinical Operations and externally contribute appropriately.

• Provides support and expertise for regulatory, ethical and administrative submissions.

• Accountable for ensuring investigator site recruitment targets and timelines are realistic and adequate to ensure recruitment to overall country commitment and developing and actively managing study patient recruitment strategies.

• Accountable for the development of the local Affiliate’s study budget, initial study resourcing forecasts and establishment of study level plans.

• Accountable for ensuring that TMF (country and site level) documentation is Inspection Ready by ensuring there are regular quality checks on the completeness and robustness of study related documents.

Study Conduct Phase:

• In accordance with the overall project plan, manages and maintains accurate country/study level plans (i.e. timelines, budget, resource, risk and quality plans) in appropriate planning system. Highlights deviations in plans to relevant parties, develops and implements mitigation strategies as required.

• Develops and maintains effective working relationships, including being the key point of contact where appropriate, with key internal and external stakeholders, including investigators, local medical team, other local departments, external vendors/CROs etc.

• In conjunction with local Head of Clinical Operations and/or Medical Manager (MM) or the Country Medical Director (CMD), ensures relationships with key investigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study.

Study Close-Out:

• Ensures all activities related to site/study close-out are managed according to local processes.

• Manages either directly or indirectly knowledge sharing activities via debriefs or other focus group activities.

Requirements:

·        Bachelor degree or equivalent, medical science major preferred

         Min. 5 years of relevant field experience including project management

   담당자: 김대식
   연락처: 02-6925-5391
   이메일: ds@hrfind.co.kr

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