Project Lead

[1] Global Clinical Research Area

• Work in close and good collaboration with Global Study Team

• Identify candidate investigators considering qualification, experience, etc.
• Engage in feasibility and site selection process
• Support to the selection of vendors including CROs, if required
• Oversee 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 well
• Perform 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 knowledge

• Prepare 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 inspections
• Ensure 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/policy
• Cooperate to generate any documents with diligent efforts
• Generate and revise internal local SOP in aligned with current activities
• Provide 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 guide
• Good ability in working according to global standards
• Good written and spoken English capabilities
• Good knowledge of computer software
• Good interpersonal skills and communication skills
• Good collaboration skills
• Good conflict management skills
• Good project management skills
• Good presentation skills
• Good change management skills
• Issue identification and Problem-solving skills
• Ability to give prioritize tasks
• Active and open-minded person to handle multi tasks in the department
• Professional and positive attitude
• Have strong agility for the self-motivation/development to be a member of high-performing team