Job Description

[1] Global Clinical Research Area

Work in close and good collaboration with Global Study TeamIdentify candidate investigators considering qualification, experience, etc.Engage in feasibility and site selection processSupport to the selection of vendors including CROs, if requiredOversee overall clinical trial status including contracts/budget negotiation, regulatory/EC submissions start up, issue management, relationship management, monitoring and site closure, data management according to assigned role and responsibilities in each project.Review and manage the label of investigational product in collaboration with RA team.Participate in the investigator’s meeting and initiation meeting to ensure CROs to give appropriate training to the relevant study staff and to put the procedure in place wellPerform regular quality oversight through eTMF functional QC, reviewing MVRs, CRO oversight visit, etc.Proactively monitor study conduct and progress (e.g. study milestones, patient recruitment, protocol compliance, GCP/regulatory compliance etc.)Oversee clinical operation performance by CRO and proactively communicate with Study Team to improve the quality.Manage KEEs with clinical science knowledgePrepare clinical trial documents or provide the relevant information to RA team for submission to regulatory authority for IND related work.Manage issues proactively through trouble shooting in collaboration with relevant stakeholders.Coordinate/support activities associated with audits and regulatory inspectionsEnsure adherence to global regulations and local regulations, Good Clinical Practices (GCPs), ICH guidelines, DS standard operating procedures (SOPs), and to quality standards in conducting clinical research.Prepare for and support publication (& publication material)

[2] Administrative Area

Plan and manage budget for the assigned projects in accordance with internal instruction/policyCooperate to generate any documents with diligent effortsGenerate and revise internal local SOP in aligned with current activitiesProvide information and update to CD team leader and other related departments about on-going and planned clinical studies/projects on a regular basis

COMPETENCIES / SKILLS

Willingness to communicate with global stakeholders through TC, etc.Good understanding of local regulation regarding safety reporting & promotional guideGood ability in working according to global standardsGood written and spoken English capabilitiesGood knowledge of computer softwareGood interpersonal skills and communication skillsGood collaboration skillsGood conflict management skillsGood project management skillsGood presentation skillsGood change management skillsIssue identification and Problem-solving skillsAbility to give prioritize tasksActive and open-minded person to handle multi tasks in the departmentProfessional and positive attitudeHave strong agility for the self-motivation/development to be a member of high-performing team
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