Clinical Research Manager
- Company
- 외국계 CRO 회사
- Position
- Clinical Research Manager
- Status
- OPEN
다음과 같이 외국계 CRO 회사에서‘CRM’ 담당자를 찾습니다.
* Job Title: CRM (Clinical Research Manager)
* 직급: 과장급 (경력 6년 이상)
* Location: 서울
[RESPONSIBILITIES]
- Responsible for the overall coordination and management of clinical research project in conjunction with the project team.
- Responsible for management of multiple protocols.
- Organize a pre-sponsor meeting with all project team members as soon as the study is awarded to the company.
- Ensure that project team is adequately trained in the project and in SOPs (the company and/or sponsor). Communicate with the sponsor on all project-related issues.
- Initiate and conduct periodic team meetings and/or conference calls to discuss the progress of the project.
- Oversee the identification of potential study sites and to screen them prior to first contact.
- Review site qualification visit reports to decide selection of investigators.
- Present at investigator meetings and review the necessity for a mid-study meeting.
- Ensure set-up and maintenance of the Trial Master File and review all relevant project-related documents.
- Ensure quality control of CRA visits, activities and collected CRF data as appropriate.
- Ensure data query flow is adhered to by all CRAs and final data queries from data management department are on fast track to ensure database lock deadlines are kept. Review and approve all initiation, interim monitoring, and close-out visit reports.
- Ensure all regulatory approvals and IRB submissions keep to projected timelines and provide immediate notification to the sponsor of any delays.
- Ensure archiving is completed correctly and in a timely manner at the end of the study.
- Advise and train CRAs as required.
- Assume ultimate responsibility for the project and proceed with minimum supervision.
- Assist in a variety of special projects as required; and perform such other duties as may be assigned.
- Undertake non-project related tasks as appropriate as assigned by the CO Director.
[QUALIFICATIONS]
- BS or Associate degree in a biomedical or related life science with at least 4 years working experience in pharmaceutical or clinical research-related industry or at least 2 years independent working experience in Management level.
- Understanding MFDS regulation, GCP and ICH-guideline.
- Extensive experiences in clinical trials.
- Good computer literacy with working knowledge of Microsoft Office applications, etc.
- Good command of written and spoken English.
- Good oral and written communication and co-ordination skills with the ability to conduct meetings.
- Experience working in a team environment under time and resource pressures.
- Understanding of the principles of project management. Ability to lead a project team.
- Excellent oral and written communication, problem solving skills, confidentiality and sensitivity, employee relation skills and personal presentation.
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently.
Only qualified candidates will be contacted for interview.
All resumes not contacted will be kept in DB confidentially for future positions.
Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Email: ceo@exdigm.com
