Study Start-Up Coordinator (Clinical Trials)

About the role

Minerva Research Solutions is a clinical trial management and support organization partnering with biotech, pharmaceutical and healthcare companies. The Study Start-Up Coordinator oversees study startup timelines and coordinates cross-functional activities so that prerequisites for Site Initiation Visits (SIV) and site activation are completed efficiently and on schedule. The role reports to the Compliance Manager and works 6 PM to 2 AM.

Key responsibilities

• Track study startup timelines against project milestones and activation goals, and coordinate cross-functional activities for study initiation
• Ensure all prerequisites for Site Initiation Visits (SIVs) are completed within timelines
• Work with Regulatory, QA, Marketing, Finance and Clinical teams to track deliverables and dependencies, identify bottlenecks and escalate risks
• Monitor progress with internal tracking tools and dashboards, keep accurate startup reports and update stakeholders regularly
• Confirm regulatory, operational and documentation prerequisites before SIV and that site activation requirements are completed and documented
• Identify risks affecting startup and help develop mitigation and contingency strategies

Required profile

• Bachelor's degree in Medical Sciences, Life Sciences, Pharmacy or a related field; MBBS, BDS or Pharm-D candidates preferred
• At least 1 year of experience in clinical research or study startup coordination
• Familiarity with regulatory requirements, clinical trial startup processes and site activation workflows
• Experience with cross-functional teams in a fast-paced environment is preferred

Required skills

• Project coordination and organizational skills
• Communication and stakeholder management
• Managing multiple timelines and priorities
• Problem-solving and risk management
• Attention to detail and accuracy in reporting and tracking tools

What we offer

• Competitive compensation with performance-based rewards
• Medical insurance and EOBI retirement benefits
• Learning and development pathways, including certifications
• Paid annual, medical and casual leave, plus parental leave
• Employee support programs and internal recognition
• Transportation allowance and family-supportive policies