Centralized Study Spec II

Job Location(s) CN-Dalian
Job Number
Job Category
Clinical Operations Management
Position Type

Job Overview

- Follow all applicable departmental Standard Operating Procedures and Work
- Complete required trainings according to required timelines. 3. Complete day-to-day tasks ensuring quality and
- Manage project and technical documentation in an appropriate
- Provide administrative and technical support to internal departments and teams as
- Perform checks to ensure quality of work
- Ensure timely escalation and issue resolution as
- Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols
- Support implementation of new monitoring tools
- Ability to work on Multiple studies and prioritize depending on conflicts
- Track and report metrics as determined by management according to required
- Proactively identify opportunities for process improvements and lead the implementation of process improvement activities to enhance
- Support the implementation of tools internally to enhance deliverables
- Able to mentor and train others
- Work with Global Stakeholders
- Assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study
- Assist in the preparation of new investigator submission packages for site/regulatory submission.
- Support study team for contracts and budgets activities for investigative sites including but not limited to Investigatory Payment, Pass through payment processing & tracking
- Assist the study start up teams with tasks required for site start up
- Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines
- Othe►rduties/activitiesas assigned by study management team, but not limited to:

Manage clinical systems
Manage study documents and support eTMF management Support study teams to resolve data management queries Maintain study databases (CTMS,  IWRS,  EDC etc.) Track and follow up with CRAs for outstanding issues Support in generating the study specific reports.

Assist in ensuring training compliance for study teamsManage internal/external communications
Manage study payments (Site and Vendor)-Ex: Payment reconciliation and release Review study performance dashboard


University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate
accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 05-08 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.


- . Years of experience in the job discipline: 06-08 Years
- Years of experience in other professional roles: 00-05 Years
- Other required work-related experiences:
Demonstrated ability to plan, prioritize, organize and communicate effectively. Demonstrated ability to pay attention to detail.
Strong interpersonal skills with ability to work well with others. Ability to deliver consistent high quality of work.
Ability to use computer and departmental tools.
Ability to Influence and Lead the processes & process improvement initiatives. Ability to facilitate meetings.
Ability to mentor and train others


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