Clinical Support Specialist
- Shanghai, China
Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18
Posted Date: Mar 18 2021
Job Purpose and Key Responsibilities:
- Provides the full-range professional, reliable and high-quality administrative service and to China Vaccine Clinical Team, provides support to clinical study on vendor management, financial, regulatory related filling and submission in accordance with company SOPs, ICH GCP guidelines and local regulations.
- Develop and maintain excellent working relationships with external and internal customers to ensure the smooth ongoing and timely delivery of clinical studies.
- If need, Perform other tasks assigned by line manager.
- As required, assist LDL with particular tasks.
- Implement study/department payments for each study or cost center by submitting via relative systems according to the company financial procedure. Including urgent payment, pre-payment, etc.
- Track study budget expenditure on a timely basis for each project and check them with local delivery lead (LDL).
- Assist the clinical study team with EPE/IPE accrual and release on a quarterly/ yearly basis.
- Provide support and help to internal/external finance audit and other finance related team.
- All the other finance support to the team.
- Vendor Related
- Support business owner to perform TPO/ABAC assessment according to GSK SOPs and closely follow up with legal, compliance, and TPO staffs on TPO tracker and CAPAs.
- Being key contact with translation vendor, support clinical team to manage translation by 3rd party in compliance with GSK SOP.
- Being Key contact with Archiving depot, support clinical team to manage clinical trial documents, department documents, investigational site documents archived in compliance with GSK SOP and GCP.
- Assists in travel bookings, accommodation, air-port transportation for China Vaccines Clinical Operations team.
- Assists internal team meeting includes Clinical Operation Meeting on quarterly basis, Medical & Clinical Operation workshop for Asian CRAs.
- Assists to reserving meeting room for staffs in Beijing office.
- Assists to provide visa and invitation letter, as well as logistic arrangement for foreign colleague's business trip to China.
- Support clinical study team in collaboration with 3rd party for printing and preparation of study material if applicable.
- Prepares logistics for newcomers, as well as introduce local admin and finance policy.
- Manage electronical documents maintenance in Share drive and easy-doc.
- Manage contractual and other key documents' signing off and stamping procedure.
- Study Related
- Support clinical study team to arrange the logistic of investigators' meeting, collaborate with SOE team to ensure all the procedure is in compliance with GSK SOP.
- Support clinical study to complete registration and update on clinical trial registration platform on time and in compliance with regulation and working instruction.
- Support clinical study on completing the documents for HGRAC submission and submit in compliance with regulation required procedures.
- Support LDL to upload and manage part of clinical trial documents in eTMF.
- Support clinical study on investigational products' temperature excursion reporting via ATEAM.
- Flexible Thinking: Seeing different perspectives on issues and usually being able to generate alternative options one after the other, rather than at the same time; Valuing alternative options for the way forward suggested by others.
- Continuous improvement: Being aware and making general statements of the need to improve performance.
- Customer Driven: Making general statements about the importance and value of customers, but taking no specific actions.
- Enable and drive change: Responding to the plans of others. Expressing frustration at obstacles to the delivery of results.
- Building Relationships: Being aware of the value of the contribution of others. Listening to the points of view of others carefully.
- degree of change & uncertainty; level of influencing required; degree of matrix working
- The holder will need to interact with multiple GlaxoSmithKline team members involved in running the trial including CRAs and LDLs
- The holder will need to interact with and manage the expectations of both internal and external stakeholders
- breadth & depth across disciplines or functions; expertise in field required; separate by basic and preferred
Must be non-comparative, objective and relevant. Critical/essential to accomplish the role
Able to complete complicated tasks independently and sharing best practice with team staff.
Relevant to the role, but not critical/essential
Bachelors degree in clinical medicine or a life/biological science Familiarity with Good Clinical Practice and relevant local regulations Good command of spoken and excellent written English and able to read it accurately Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and familiarity with the internet Clinical study related experience in the top pharmaceutical or CRO is preferred.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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