Project Lead
Korea, Republic of, Remote Job ID R0000022212 Category Clinical TrialsAbout this Role
[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
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