Project Lead - FSP

Key Accountabilities:

Project Initiation and planning: Works collaboratively with the study team to
• Identify candidate investigators considering qualification, experience, etc.
• Engage in feasibility and site selection process
• Support the selection of vendors including Clinical Research Organizations (CROs), if required
• Oversee overall clinical trial status including contracts/budget negotiation, regulatory/Ethics Committee (EC) submissions, start-up activities, issue management, and relationship management according to assigned role and responsibilities in each project
• Prepare clinical trial documents or provide relevant information to Regulatory Authority (RA) team for submission to regulatory authority for Investigational New Drug (IND) related work
• Review and manage the label of investigational product in collaboration with Regulatory Authority (RA) team
• Participate in the investigator’s meeting and initiation meeting to ensure CROs provide appropriate training to the relevant study staff and ensure proper study process and procedures are followed
• Oversee issue management, relationship management, monitoring and site closure, and data management according to assigned role and responsibilities in each project Perform regular quality oversight visits through Electronic Trial Master File (eTMF) functional Quality Check (QC), reviewing monitoring visit reports (MVRs), CRO oversight visit, etc.
• Proactively monitor study conduct and progress (e.g., study milestones, patient recruitment, protocol compliance, GCP/regulatory compliance etc.)
• Oversee the clinical operation performance by the CRO and proactively communicate with the Study Team to improve the quality
• Manage issues proactively through trouble shooting in collaboration with relevant stakeholders
• Manage Key External Experts (KEEs) with clinical science knowledge
• Coordinate/support activities associated with audits and regulatory inspections
• Prepare for and support publication (and publication material)

Administrative

Plans and manages the budget for the assigned projects
• Cooperates to generate any documents with diligent efforts
• Generates and revises internal client local SOPs in aligned with current activities
• Provides information and updates to the clinical development team leader and other related departments regarding

Compliance with Parexel standards

Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:
• Good understanding of local regulations regarding safety reporting & promotional guidance documents
• Proficient knowledge of computer software (e.g., MS Office Suite (Word, Excel, Power Point)
• Effective interpersonal, communication, and presentation skills. Willingness to communicate with global stakeholders through teleconference, etc.
• Effective collaboration, project management skills
• Good conflict management skills
• Effective issue identification and problem‐solving skills
• Ability to effectively prioritize workload
• Professional and positive attitude; self-motivated to perform as a member of a high-performing team
• Proficient in written and spoken English language required
• Proficient in local language required

Knowledge and Experience:
• Relevant work experience as a Clinical Research Associate (CRA) or minimum 3-5 years relevant experience (preferably on-site monitoring experience)

• Relevant Coordinating experience preferably obtained while working in a Senior CRA
• Minimum 3-5 years of experience in clinical research in Clinical functions with a potential to understand cross-functional activities related to data processing, data cleaning, and site management
Education:
• Degree in a Life Sciences, Nursing, or other Medical Sciences