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Associate Clinical Operations Manager (ACOM)  /  外資製薬メーカー

ジョブNo.jsid1325841
職種 Associate Clinical Operations Manager (ACOM)
社名 外資製薬メーカー
業務内容 <Primary Function/ Primary Goals/ Objectives 主な役割/目標/目的>
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
The Associate Clinical Operations Manager (ACOM) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
Additionally, the ACOM may train and provide guidance to junior staff.

<Core Job Responsibilities/ Accountability / Scope ( Major Duties and Responsibilities) アカウンタビリティ(主な責任)/範囲>
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Supports the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US) / region (US) of responsibility.
In the country/region based, may manage up to 6 SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies.
Gives support in providing ongoing assessment of resource needs and in allocating resources in alignment with AbbVie’s research goals, priorities and specific study timelines. Identifies and communicates issues that impact resource allocation and provides solutions.
For direct reports, ensures clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives. Anticipates and identifies site issues that could affect timelines and develops alternative solutions.
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard
Operating
……(以下詳細は面談時にご案内します)
求める経験 <Education 教育>
Bachelor’s Degree required; medical/science/nursing background preferred;
MS, MA, MBA, MPH desired
<Background (Experience) 経歴 (経験) >
Minimum of 5 years of clinical related experience, with a minimum of 2 years as clinical research monitor.
Expert knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
Expert knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
<Required Functional Competencies その役割に必要とされるコンピテンシー >
Proven strong site management and monitoring skills
Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
Acute observational skills, analytical and conceptual capabilities.
Exhibit high degree of flexibility when facing changes in the work environment
Attention to detail and strong interpersonal skills.
Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and
web-browser applications.
Working knowledge and high experience with electronic data capture systems and clinical trials management systems.
Strong ability to work independently in a geographic region with minimal supervision.
The ACOM anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The ACOM should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
The ACOM may be assigned as Country Project Lead (functional role ・ see role description “Country Project Lead”) and serve as a “study Subject Matter Expert (SME)” regarding monitoring/site management tasks in support of Site Management & Monitoring staff assigned to a particular protocols.
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.

語学力 英語力:中級
勤務地
大阪府 東京都
年収 900万円 - 1200万円
雇用形態 正社員(期間の定めなし)

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