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Vietstar BioMedical Research

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🔔 Tuyển Dụng 🔔 Clinical Research Manager (Quản Lý Bộ Phận Hỗ Trợ Nghiên Cứu Thử Nghiệm Lâm Sàng)

Vị trí

Clinical Research Manager

Lương

Lương thỏa thuận

Loại hình công việc

Full-Time

Thời hạn bài đăng

Jun 22 2019 ~ Jul 22

Chi tiết

🔶 JOB DESCRIPTION Responsible for the line management, selection, training, coaching and performance management of Clinical Research Associates. Focusing on end results to be achieved, uses metrics and key performance indicators to manage individual and team performance. May lead the Clinical Management team, or may lead or contribute to initiatives that enhance Clinical Development/Vietstar business objectives. Lead and/or participate in local and regional cross functional initiatives and process improvement projects. - The post-holder will also play a key role in all aspects of research and support including protocol generation, IRB submission, control and management of regulatory documents, data management and development and supervision of other staff responsible for coordinating and monitoring VIETSTAR studies. - Manage CRC team and Supervise a team of clinical research coordinators - Oversee protocol and CRF development and implementation. - Liaise with staff at CTU VIETSTAR-HCMC to ensure that documentation and approaches are streamlined and congruous. - Support the preparation and presentation of applications to ethical committees and regulators - Understand the study protocols, assist in recruitment of patients to studies if required - Ensure data entry into electronic databases, data cleaning and validation is timely and accurate - Develop monitoring plans, if necessary. - Implement or oversee the implementation of monitoring plans based on study progress - Maintain good communication with collaborating staff at study sites, to ensure participants’ wellbeing, compliance with study protocols and quality of clinical data. - Build a good relationship with study sites and act as a liaison between VIETSTAR and the site - Other tasks as required Knowledge, Skills and Abilities: - Demonstrate effective in management of group and team/leadership/supervisory ability including excellent interpersonal skills. - Excellent clinical trials monitoring skills. - Demonstrate understanding of or ability to learn and demonstrate understanding of SOPs, and relevant regulations e.g. ICH/GCP, FDA guidelines). - Demonstrate ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology. - Effective organizational and negotiation skills. - Strong attention to detail. - Effective written and oral communication skills. - Excellent team player with team building skills. - Excellent interpersonal and conflict resolution skills. - Utilize problem-solving techniques applicable to constantly changing environment. - Proficient knowledge of medical/therapeutic areas and medical terminology. 🔶 POWER - The post-holder will also play a key role in all aspects of research and support including protocol generation, IRB submission, control and management of regulatory documents, data management and development and supervision of other staff responsible for coordinating and monitoring VIETSTAR studies. - He/she should be pro-active and ensure the work is of high standard. 🔶 REQUIREMENT - Experience in clinical trials - Experience managing teams - Significant clinical research experience (comparable to 4 years) including clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out. - Line management experience appropriate to the size and complexity of the clinical management group. 🔶 BENEFICIARY - Contracted salary: 20-25 millions Vietnam dongs or Negotiate (depending on actual experience and education) - Vietnam Social & Health insurance - 13th month salary (annual bonus), Anniversary, Pinic, team building, travel - Annual leave 12 days/year

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Phòng 2, tầng 5, toà nhà HORISON TOWER, 40 Cát Linh, Hà Nội