Study Start-Up Coordinator(Clinical Trials)

Study Start-Up Coordinator
Department: Study Start-Up
Reports To: Compliance Manager
Timings: 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 services throughout the study lifecycle. The Study Start-Up Coordinator plays a critical 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, mitigate 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 required for study initiation and ensure all prerequisites for Site Initiation Visits (SIVs) are completed within timelines.
- Cross-Functional Alignment: Collaborate with Regulatory, Quality Assurance, Marketing, Finance, and Clinical teams to track deliverables and dependencies. Identify bottlenecks impacting startup timelines and escalate risks as needed. Facilitate 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 appropriately documented. Support smooth coordination leading to successful site activation.
- Risk Management: Identify potential risks affecting study startup activities and timelines. Collaborate with stakeholders to develop mitigation and contingency strategies. Monitor ongoing startup 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 is preferred.

Preferred Qualifications
- Candidates with MBBS, BDS, or Pharm-D degrees will be given preference.

Key Skills & 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.

Key Performance Indicators (KPIs)
- On-time completion of study startup milestones.
- Adherence to SIV and site activation timelines.
- Number of delays or escalations successfully mitigated.
- Effectiveness of cross-functional coordination and communication.
- Accuracy and timeliness of startup reporting and tracking.

Benefits and What You’ll Gain at Minerva Research Solutions
- Competitive compensation with performance-based rewards.
- Comprehensive medical insurance and 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 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.