Study Start-Up Coordinator(Clinical Trials)

Responsibilities

• Study Start-Up Reports To: Compliance Manager Timings : 6PM - 2AM Job Summary About Minerva Research Solutions Minerva Research Solutions is a leading Clinical Trial Management and Support organization dedicated to advancing global healthcare through innovation, operational excellence, and regulatory compliance.
• We partner with biotech, pharmaceutical, and healthcare organizations to deliver integrated clinical trial support services across the full study lifecycle.
• At Minerva, we are committed to maintaining the highest standards of quality, compliance, and efficiency while enabling breakthrough therapies to reach patients faster.
• The Study Start-Up Coordinator is responsible for overseeing study startup timelines and coordinating cross-functional activities to ensure all prerequisites for Site Initiation Visits (SIV) and site activation are completed efficiently and on schedule.
• This role serves as the central coordination point between departments to monitor dependencies, mitigate delays, and ensure operational readiness for successful study activation.
• Key Responsibilities 1.
• Study Start-Up Planning & Coordination Track study startup timelines aligned with project milestones and activation goals.
• Coordinate cross-functional activities required for study initiation.
• Ensure all prerequisites for Site Initiation Visits (SIVs) are completed within timelines.
• 2.
• Alignment Coordinate with Regulatory, QA, Marketing, Finance, and Clinical teams to track deliverables and dependencies.
• Identify bottlenecks impacting startup timelines and escalate risks appropriately.
• Facilitate communication between departments to maintain alignment on project objectives and deadlines.
• 3.
• Timeline & Milestone Tracking Monitor progress against startup timelines using internal tracking tools and dashboards.
• Maintain accurate startup reports and provide regular status updates to stakeholders.
• Proactively address delays and support implementation of corrective actions.
• 4.
• SIV Readiness & Site Activation Ensure all regulatory, operational, and documentation prerequisites are fulfilled prior to SIV.
• Confirm site activation requirements are completed and appropriately documented.
• Support smooth coordination leading to successful site activation.
• 5.
• Risk Management Identify potential risks impacting study startup activities and timelines.
• Collaborate with stakeholders to develop mitigation and contingency strategies.
• Monitor ongoing startup risks and ensure timely resolution of issues.
• Key Performance Indicators (KPIs) On-time completion of study startup milestones

Requirements

• & Experience Bachelor’s degree in Medical Sciences, Life Sciences, Pharmacy, or a related field.
• MBBS, BDS, or Pharm-D candidates will be preferred.
• Minimum 1 year of experience in clinical research or study startup coordination.
• & Competencies Strong project coordination and organizational skills
• Excellent communication and stakeholder management abilities
• Ability to manage multiple timelines and priorities effectively
• Strong problem-solving and proactive risk management capabilities
• Attention to detail with a quality-focused mindset
• Proficiency in reporting and startup tracking tools
• Adherence to SIV and site activation timelines
• Number of delays/escalations successfully mitigated
• Effectiveness of cross-functional coordination and communication
• Accuracy and timeliness of startup reporting and tracking

Preferred

• Familiarity with regulatory requirements, clinical trial startup processes, and site activation workflows.
• Experience working with cross-functional teams in a fast-paced environment is preferred.

Benefits

• You’ll Gain at Minerva Research Solutions Competitive compensation with performance-based rewards
• Comprehensive medical insurance EOBI retirement benefits
• Structured Learning & Development pathways, including certifications and career mobility
• Paid annual, medical, and casual leave
• Mental well-being and employee support programs
• Inclusive, collaborative, and growth-driven work culture
• Internal recognition & employee engagement initiatives

Modern digital tools and a technology-forward workplace

• Transportation allowance for staff Family-supportive policies, including parental leave
• Opportunities to contribute to community and social impact programs