Study Start-Up Coordinator (Clinical Trials)

Minerva Research Solutions is a prominent Clinical Trial Management and Support organization committed to advancing global healthcare through innovation, operational excellence, and strict regulatory compliance. Collaborating with biotech, pharmaceutical, and healthcare partners, Minerva provides comprehensive clinical trial support services throughout the entire study lifecycle. The Study Start-Up Coordinator plays a vital role in managing study startup timelines and coordinating cross-functional activities to ensure all requirements for Site Initiation Visits (SIV) and site activation are met efficiently and on schedule. Serving as the central liaison between departments, this position monitors dependencies, addresses potential delays, and guarantees operational readiness for successful study activation. The role operates from 6 PM to 2 AM and reports directly to the Compliance Manager.

Key Responsibilities

Study Start-Up Planning & Coordination: Oversee and track study startup timelines, ensuring alignment with project milestones and activation objectives. Coordinate necessary cross-functional activities to facilitate study initiation and confirm all prerequisites for Site Initiation Visits (SIVs) are completed within set deadlines.

Cross-Functional Alignment: Work closely with Regulatory, Quality Assurance, Marketing, Finance, and Clinical teams to monitor deliverables and dependencies. Identify bottlenecks that may impact startup timelines and escalate risks when necessary. Facilitate effective communication across departments to maintain alignment on project goals and timelines.

Timeline & Milestone Tracking: Utilize internal tracking tools and dashboards to monitor progress against startup timelines. Maintain accurate and up-to-date startup reports, providing regular status updates to stakeholders. Proactively manage delays and support the implementation of corrective measures.

SIV Readiness & Site Activation: Ensure all regulatory, operational, and documentation requirements are fulfilled prior to Site Initiation Visits. Verify that site activation criteria are met and properly documented, supporting seamless coordination for successful site activation.

Risk Management: Identify and assess potential risks affecting study startup activities and timelines. Collaborate with relevant stakeholders to develop mitigation and contingency plans. Continuously monitor risks and ensure timely resolution of issues to avoid disruptions.

Required Qualifications

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

Preferred Qualifications

Candidates with MBBS, BDS, or Pharm-D degrees are highly preferred.

Benefits and Work Culture

Minerva Research Solutions offers competitive compensation packages with performance-based incentives. Employees receive comprehensive medical insurance and EOBI retirement benefits. The company supports professional growth through structured learning and development programs, including certifications and career advancement opportunities. Paid annual, medical, and casual leaves are provided, alongside mental well-being and employee support initiatives. Minerva fosters an inclusive, collaborative, and growth-oriented work environment, reinforced by internal recognition and employee engagement activities. Staff benefit from access to advanced digital tools in a technology-driven workplace and receive transportation allowances. Family-friendly policies, including parental leave, are in place, with opportunities to participate in community and social impact programs.

This role provides an excellent opportunity for individuals seeking to contribute to clinical trial success while working within a supportive and innovative organization.