2h ago

New

Associate Clinical Operations Leader

IndiaRemoteFull-timelead

OperationsOperations Manager

1 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Remote Work: Work remotely from India, with the opportunity to collaborate with colleagues and stakeholders across global locations.

Requirements Summary

Ensure study activities comply with International Council for Harmonisation Good Clinical Practice (ICH-GCP), applicable local regulatory requirements, standard operating procedures (SOPs),

Technical Tools

OperationsOperations Manager

Join a collaborative clinical research team dedicated to advancing medical innovation and improving patient outcomes through high-quality clinical trials. In this role, you will support the planning, coordination, and execution of clinical studies across assigned countries and project activities. Working alongside experienced clinical operations leaders, you will help ensure studies progress efficiently from start-up through close-out while maintaining rigorous quality and regulatory standards. You will coordinate cross-functional teams, monitor study performance, address site challenges, and contribute to effective patient recruitment and retention strategies. This opportunity combines clinical operations expertise, stakeholder engagement, and team coordination in a dynamic, globally connected environment. You will also have opportunities to strengthen your leadership capabilities, contribute to process improvements, and support the delivery of treatments that can make a meaningful difference in patients' lives.

Clinical Team Coordination: Coordinate and guide clinical project team members on small to midsize studies, establish productivity targets, provide performance feedback, and contribute to study-specific training.

Study Start-Up and Planning: Support study initiation activities by contributing to project plans, site selection strategies, monitoring plans, and patient recruitment and retention strategies.

Study Performance Monitoring: Track project timelines, patient enrollment and retention, site performance, and data-cleaning progress to support timely, high-quality study delivery.

Site Management and Issue Resolution: Address escalated site issues, identify operational risks early, conduct root cause analysis, and support the development and implementation of contingency plans.

Stakeholder Communication: Maintain effective communication with internal teams, sponsors, clinical investigators and research sites, external customers, and third-party vendors, responding promptly to urgent requests and emerging concerns.

Resource Management: Assess project staffing and resource requirements, monitor resource utilization throughout the study life cycle, and support efficient allocation of clinical operations resources.

Regulatory Compliance and Quality Assurance: Ensure study activities comply with International Council for Harmonisation Good Clinical Practice (ICH-GCP), applicable local regulatory requirements, standard operating procedures (SOPs), work instructions, and operational guidelines.

Audit and Inspection Readiness: Prepare for and participate in audits and inspections, maintain accurate study documentation, and support the quality review and upkeep of central study files.

Study Close-Out and Data Management: Collaborate with project leaders and data operations teams on database lock, project close-out, documentation, and archiving activities.

Cross-Functional Collaboration: Work with global project management teams and cross-functional stakeholders to coordinate deliverables, resolve operational challenges, and maintain alignment across study activities.

Continuous Improvement: Contribute to process improvement initiatives, document lessons learned during study close-out, and identify opportunities to enhance operational efficiency and study quality.

Team Development: Act as a positive role model, share clinical operations knowledge, and help foster accountability, collaboration, and continuous learning across virtual teams.

Requirements

~2 min read

Education: A degree in life sciences, a nursing qualification, or equivalent relevant clinical or clinical management experience.

Clinical Research Experience: Substantial experience in clinical research operations, including experience as a Clinical Research Associate (CRA) or in an equivalent clinical research role.

Clinical Trial Knowledge: Strong understanding of the full clinical trial life cycle, including study start-up, site management, monitoring, data cleaning, close-out, and archiving.

Regulatory and Compliance Expertise: Knowledge of ICH-GCP guidelines, local regulatory requirements, clinical trial procedures, and applicable quality standards.

Clinical Coordination Experience: Experience coordinating clinical activities or teams is preferred, particularly experience gained in a Senior CRA or Senior Clinical Management Associate (CMA) position.

Monitoring Experience: Previous on-site clinical monitoring experience is an advantage.

Leadership and Stakeholder Management: Ability to coordinate virtual teams across different locations and cultures, influence stakeholders diplomatically, negotiate effectively, and build trusted working relationships.

Analytical and Problem-Solving Skills: Strong root cause analysis, issue resolution, and critical-thinking abilities, with the capacity to anticipate risks and implement practical solutions.

Communication Skills: Excellent written and spoken English, with proficiency in relevant local languages where required for assigned countries.

Organization and Time Management: Strong planning, prioritization, and multitasking skills, combined with attention to detail, a sense of urgency, and a commitment to high-quality work.

Technical Proficiency: Working knowledge of Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook, as well as WebEx or comparable collaboration tools. Willingness to learn and become proficient in relevant clinical operations systems.

Adaptability and Collaboration: Ability to work effectively with cross-functional teams, manage competing priorities, respond to changing study needs, and contribute positively to a fast-paced, international environment.

Travel Flexibility: Willingness and ability to travel when required by assigned studies or project responsibilities.

What We Offer

~2 min read

Remote Work: Work remotely from India, with the opportunity to collaborate with colleagues and stakeholders across global locations.

Flexible Work Environment: Be part of an organization that values flexibility and supports employees in doing their best work.

Professional Development: Expand your clinical research expertise while developing project coordination, leadership, and stakeholder management skills.

Career Growth: Gain exposure to small and midsize clinical studies, cross-functional project management, and opportunities to broaden your responsibilities.

Meaningful Impact: Contribute to clinical research that supports the development of new therapies and helps improve patient outcomes.

Collaborative Culture: Work with experienced clinical operations professionals in a diverse, internationally connected team.

Continuous Learning: Strengthen your knowledge of clinical trial processes, regulatory compliance, study quality, and operational best practices.

Process Improvement Opportunities: Participate in initiatives that enhance clinical research efficiency, quality, and delivery.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1

✓Remote Work: Work remotely from India, with the opportunity to collaborate with colleagues and stakeholders across global locations.

✓Flexible Work Environment: Be part of an organization that values flexibility and supports employees in doing their best work.

✓Professional Development: Expand your clinical research expertise while developing project coordination, leadership, and stakeholder management skills.

✓Career Growth: Gain exposure to small and midsize clinical studies, cross-functional project management, and opportunities to broaden your responsibilities.

✓Meaningful Impact: Contribute to clinical research that supports the development of new therapies and helps improve patient outcomes.

✓Collaborative Culture: Work with experienced clinical operations professionals in a diverse, internationally connected team.

✓Continuous Learning: Strengthen your knowledge of clinical trial processes, regulatory compliance, study quality, and operational best practices.

✓Process Improvement Opportunities: Participate in initiatives that enhance clinical research efficiency, quality, and delivery.