Clinical Studies Specialist Coordinator II
Location: Mumbai, Maharashtra, India (Remote)
Company: Medtronic
Employment Type: Full-Time
Job ID: R60011
About Medtronic
Medtronic is a global leader in healthcare technology, dedicated to improving patient outcomes and expanding access to life-changing therapies. With a mission to alleviate pain, restore health, and extend life, Medtronic brings together more than 95,000 professionals worldwide to develop innovative medical technologies and solutions that address the world’s most complex healthcare challenges.
The organization is currently seeking a Clinical Studies Specialist Coordinator II to support clinical research operations and study coordination activities. This role involves managing clinical study documentation, coordinating study data processes, and ensuring the accuracy and completeness of clinical trial records in accordance with protocol requirements and regulatory standards.
Experience Required
Candidates should have a minimum of 2 years of relevant experience in clinical research coordination, clinical data management, or clinical trial support within the pharmaceutical, biotechnology, medical device, or CRO industry.
Key Responsibilities
Support the execution and coordination of clinical studies by managing study-related documentation and data processes.
Participate in the development and testing of case report forms (CRFs), clinical study reports, and study databases based on clinical protocol requirements.
Ensure timely and accurate completion of clinical study data forms and verify data quality throughout the study lifecycle.
Identify, manage, and resolve data discrepancies while maintaining data integrity and compliance with study guidelines.
Coordinate clinical study documentation, including creation, organization, and maintenance of study files.
Oversee the distribution and management of clinical trial documents across relevant teams and stakeholders.
Assist with periodic audits of clinical study files to ensure completeness, regulatory compliance, and documentation accuracy.
Support study compensation processing and investigate any discrepancies in compensation records.
Provide administrative and operational support to clinical research teams and assist in maintaining efficient workflow processes.
Identify potential issues within study coordination processes and recommend improvements or solutions.
Role Scope and Work Environment
This role is part of the Office Support Career Stream, where professionals provide administrative and operational support to clinical and organizational teams. The position typically involves routine operational activities, with opportunities to apply prior experience to improve processes and support study execution.
Autonomy and Work Structure
Work independently on assigned administrative and coordination tasks under moderate supervision.
Apply established procedures while making minor adjustments to improve efficiency or resolve routine issues.
Contribute to the achievement of day-to-day operational objectives within the clinical research team.
Communication and Collaboration
Communicate regularly with internal teams, including clinical operations, data management, and regulatory personnel.
Provide and obtain information requiring interpretation or clarification related to study processes.
May provide guidance or onboarding support to entry-level team members.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, Healthcare Administration, or a related field.
Minimum 2 years of experience in clinical research, clinical study coordination, or clinical data management.
Working knowledge of clinical trial processes, documentation standards, and data management systems.
Strong organizational and documentation management skills.
Ability to identify discrepancies and ensure data accuracy within clinical studies.
Effective communication and collaboration skills for working with cross-functional teams.
Proficiency in Microsoft Office and clinical research documentation systems.
Compensation and Benefits
Medtronic offers a competitive salary along with a comprehensive benefits package designed to support employees throughout their career journey. Benefits are structured to promote well-being, professional growth, and work-life balance.
Key offerings may include:
Competitive compensation and performance-based incentives
Participation in the Medtronic Incentive Plan (MIP)
Health and wellness programs
Professional development and career growth opportunities
Flexible benefits and employee support resources
Why Join Medtronic
Medtronic is committed to fostering innovation, diversity, and inclusion while addressing some of the most pressing healthcare challenges worldwide. Employees work in a collaborative environment that encourages exploration, creativity, and continuous improvement.
Professionals joining Medtronic contribute to a global mission to transform healthcare and deliver technologies that improve and extend lives.
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