Study Start-Up Coordinator(Clinical Trials)

Study Start-Up Coordinator
Department: Study Start-Up
Reports To: Compliance Manager
Working Hours: 6 PM – 2 AM

Minerva Research Solutions is a leading Clinical Trial Management and Support organization committed to advancing global healthcare through innovation, operational excellence, and regulatory compliance. We collaborate with biotech, pharmaceutical, and healthcare organizations to provide integrated clinical trial support throughout the study lifecycle. The Study Start-Up Coordinator plays a crucial role in managing 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 position acts as the central liaison among departments to monitor dependencies, address delays, and ensure operational readiness for successful study activation.

Key Responsibilities
- Study Start-Up Planning & Coordination: Track study startup timelines aligned with project milestones and activation goals. Coordinate cross-functional activities necessary for study initiation. Ensure all prerequisites for Site Initiation Visits (SIVs) are completed within established timelines.
- Cross-Functional Alignment: Collaborate with Regulatory, Quality Assurance, Marketing, Finance, and Clinical teams to monitor deliverables and dependencies. Identify bottlenecks impacting startup timelines and escalate risks as needed. Facilitate effective communication between departments to maintain alignment on project objectives and deadlines.
- 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 the implementation of corrective actions.
- SIV Readiness & Site Activation: Ensure all regulatory, operational, and documentation prerequisites are fulfilled prior to SIV. Confirm site activation requirements are completed and properly documented. Support smooth coordination to enable successful site activation.
- Risk Management: Identify potential risks affecting study startup activities and timelines. Work with stakeholders to develop mitigation and contingency strategies. Monitor ongoing risks and ensure timely resolution of issues.

Required Qualifications
- Bachelor’s degree in Medical Sciences, Life Sciences, Pharmacy, or a related field.
- Minimum of 1 year of experience in clinical research or study startup coordination.
- Familiarity with regulatory requirements, clinical trial startup processes, and site activation workflows.
- Experience working with cross-functional teams in a fast-paced environment.

Preferred Qualifications and Benefits
- Candidates with MBBS, BDS, or Pharm-D degrees are preferred.
- Competitive compensation with performance-based rewards.
- Comprehensive medical insurance and EOBI retirement benefits.
- Structured Learning & Development pathways, including certifications and career mobility opportunities.
- Paid annual, medical, and casual leave.
- Mental well-being and employee support programs.
- Inclusive, collaborative, and growth-driven work culture.
- Internal recognition and employee engagement initiatives.
- Access to 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.

This role offers an excellent opportunity to contribute to impactful clinical research while growing professionally within a supportive and innovative environment.