AbbVie Medica Study Manager in Shanghai, China
Medica Study Manager
China, Shanghai, Shanghai
Research & Development
PhaseIV Clinical trial and PMOS
Responsible for execution and management for Phase IV Clinical trial (Affiliate or Area/Affiliate Funded) which including Post Marketing Observational study(PMOS) and interventional studies using Abbvie product as investigational drug.
PerformanceManagement of CRC and CRA from CRO. Setup clinical trial team.
SiteManagement :Screening and selection of sites and investigators .
DevelopSite patient recruitment strategies
Database andData Management : Database established, ElectronicData Capture
Lead Biostatistics,interim analysis report.
Budgetmanagement: Responsible on financial expenses together with Budget planning andphasing.
ContractManagement :Responsible for the contract preparation and negotiation,finalization and signature with hospitals and institution.
Insurance andsubjectsAE compensationin clinical trial as needed.
Study drugpackaging and distribution management as needed.
InvestigatorInitiated Studies and other programs
Responsible for Sponsorship qualification ,contract negotiation/signature and Payment/Study Drug Packaging /shipment schedule for Investigator Initiated Studies. Provide Abbvie Support to the sponsor on the EC approval and regulatory submission as needed.
Responsible for other data generation projects from qualification assessment to contract negotiation/signature and payment schedule.
Responsible for Research grant ,third party studies, In vivo/in vitro assessment, contract negotiation and payment schedule.
Vender Managementand Sourcing
Responsible for vender qualification assessment with QA team, contract, performance management and payment according to Abbvie relevant policies and procedures.
The vendor or external service provider on medical studies are including but not limited to Clinical Research Organization( CRO), but also including the service on electronic data capture, remote monitor, virtual clinical trials, central labs, detective devices, bio statistical services related to data generation process.
Responsible on the quality of the service provided by the vendor according Abbvie standard.
People andperformance management
Manages and Lead contract CRAs on site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 4 studies. Builds and maintains a high performance team of monitoring staff.
Manages and Lead contract CRAs on patient recruitment ,and other investigator responsible tasks in a high efficient way according to study plan.
Documentation, System and Compliance
Archiving all the essential documents cross the program life cycle in required systems and format, such as TMF and SharePoint, ensure the access control and version control and information security.
Ensure all the Abbvie information assets including electronic database in Service providers are compliance and security. Archive the database within Abbvie after the project completed.
Quality,Audit/inspection and Internal Collaboration
Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
Work with relevant functions with Global, Regional and china to ensure the program quality control and no critical findings from internal audit both in Clinical trial operation and information security.
Bachelor oradvance degree in clinical medicine or Pharmacology, qualification on GCP.Demonstrate a understanding on GPP, GVP,GLP,GPP,Code fConduct of Pharmateutic industry such as RDPACCode is preferred.
Minimum of 2years of clinical trial management experiencein the Pharma or CRO as CRA,CRM or Project Manager.
Solidknowledge on various documents in clinical trial management and deeply understandingthe tasks of Sponsor.Records on professionalwriting skills and expertisewith examples ofproject t sheets, clinical trial operation.
Demonstratestrong learning agility to execute evidence generation programs with highefficiency, productivity and quality.
A demonstratedability to develop and maintain strong collaborative partnerships with differentfunctions andability towork with English Spoken Colleagues.
High customerorientation and willingness for collaboration and helping others.
Intermediateor advance IT knowledge , familiar with the SharePoint, Veeva TMF, Oracle, SAP,Medidata RAVEoperation system andproject management softwareispreferred.
Travel: Yes, 25 % of the Time
Job Type: Experienced