Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
Associate Clinical Trial Manager (외국계 제약사 Dedicated)Job ID 52253BR Seoul, Seoul, South Korea
The role of Associate Clinical Trial Manager (Ass CTM) is expected to assist the Global / Regional Study Manager in the operational execution of clinical studies. The employee is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Allergan departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
The contractor is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The contractor must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
KEY Responsible Roles AND RESPONSIBILITIES:
Associate Clinical Trial Manager(90%):
The incumbent ensures all site related activities and files are completed per the SOPs. The employee is a key point of contact for study specific questions from both internal (eg, site monitors, clinical services specialist) and external (eg, site personnel, vendors) customers. They facilitate communication across departments and elevate site and study issues as appropriate.
The incumbent reviews clinical data through various sources in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate. They perform quality checks of all study plans (eg, monitoring plan) and study reports. They review and code protocol deviations.
The incumbent sets-up, tests, reviews, and updates clinical systems (eg, CTMS) and tracking tools. They are responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
Global Brand R&D personnel (5%): The incumbent is responsible for completing all required training to execute their job and maintain training records. They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.
General Compliance and Other Role(5%): The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.
Qualifications*모니터링 경력 3~4년 이상 지원 가능
*Regional role로써 담당 projects에서 Regional CTM 을 support 하는 업무임. (모니터링 없음.)
*외국계 제약사 오피스 근무 (강남역)
Qualifications / Experience
- B.A./B.Sc. preferably in science or health-related field
- Previous experience of clinical study management
- Oversight or mentoring of more junior study monitors (direct or indirect) preferred
Knowledge and Skills
Employee must have a good understanding of the following:
- Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
- Knowledge of concepts of clinical research and drug development, and
- General therapeutic area education and training
- Handle and prioritize multiple tasks simultaneously,
- Work effectively in a team/matrix environment,
- Understand technical, scientific and medical information,
- Handle conflict management and resolution,
- Understand clinical study budgets,
- Plan, organise, project manage and analyse data, and demonstrate full competency in Microsoft Office programs.
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