Experiences Desired
Demonstrate******** of the operational process for the development ofPhase IV, BMS Sponsore********, Investigator Sponsore********an********-Marketing Surveillance Research
Responsible for oversight an******** of budgets for all researchoperationalize******** OCPO within China
Demonstrate******** in budget management
Oversees the OCPO research processes to ensure study timelinesan******** are met appropriately.
Manages all aspects of research assigne******** start to finish
Demonstration of strong Project an******** management skills
Demonstrate******** an******** able to manage studies acrossorganization ( i.e. multiple TAs an******** portfolio of research)
Ensures global standardize******** are followe******** the managementof OCPO manage********
Provide country feedback on OCPO study operating model
Ensures country diversity an******** needs (regulat******** languages,tools are considere******** all aspects of research operations as wellas policies an********
Reviews an******** important study documents such as CRFs, monitoringplans, training ******** etc.
Coordinates or contributes to key clinical documents (e.g. Protocols,Protocol Template********).
Works with outsourcing group to formalize vendor Request for Proposals(RFPs) to ensure accuracy of operational details
Manages Contract Research Organizations (CROs) or external vendorrelationships
Ensures OCPO Global an******** team maintain strong transparentrelationship with global procurement
Ability to identify potential barriers to study completion an********effective strategies that facilitate study conduct.
Demonstrate******** to manage Sponsor-Investigator research, monitorstudy progre******** enrollment an******** establishe******** t********demonstrating strong capabilities in appropriate proactive interventionwhen necessary.
Participates in interactions among many different groups includingFiel******** Sc******** Medical Strategy, , Biomarker Team, GPV&E,Regulatory, labs, principal scientists an********
Enhances transparency an******** sharing between OCPO Globalan********
Demonstrate******** an******** to change.
Computer literate an******** to operate independently within anenvironment that relies heavily on technology for information an********tool.
Experience working within the pharmaceutical industry.
Demonstrate******** to multi-task an******** high performance demands.
Fluency in both English an******** languages written an********.
Knowledge Desired
Minimum education BA/BS.
Prefer individual with strong science background, Nurse, PA, NP, PharmD, PhD
Knowledge of general clinical research including its processes,procedures an********.
Knowledge of the pharmaceutical industry an******** stu******** PhaseIV, BMS Sponsore******** an******** components.
Knowledge of goo******** practices (GCP) an******** Guidelines.
Knowledge of an******** experience with CFDA woul******** a distinctadvantage.