Clinical Studies Specialist Coordinator II – Remote | Medtronic | Mumbai, India
Location: Remote (Based in Mumbai, Maharashtra, India)
Company: Medtronic
Job Type: Full-Time
Job Category: Clinical Research / Clinical Operations
Experience Required: Minimum 2 Years
Education: Bachelor’s degree in Life Sciences, Clinical Research, Healthcare, or a related discipline
About Medtronic
Medtronic is a global leader in healthcare technology, focused on developing innovative medical solutions that improve patient outcomes and expand access to healthcare worldwide. With more than 95,000 employees across the globe, Medtronic is driven by its mission to alleviate pain, restore health, and extend life.
The organization fosters a culture of innovation, collaboration, and inclusivity, empowering professionals to contribute to groundbreaking advancements in medical technology, clinical research, and patient care. Medtronic offers a dynamic environment for professionals seeking to build long-term careers while making a meaningful impact on global healthcare.
Job Overview
Medtronic is seeking a Clinical Studies Specialist Coordinator II to support the coordination and management of clinical research activities. This role is responsible for assisting in the execution of clinical studies through effective data coordination, document management, and administrative support.
The position plays a critical role in ensuring accurate clinical data management, compliance with study protocols, and efficient documentation processes. The ideal candidate will possess strong organizational skills, clinical research knowledge, and the ability to manage multiple operational tasks within a regulated healthcare environment.
Key Responsibilities
Clinical Data Coordination
Support the development, testing, and maintenance of case report forms (CRFs), clinical study reports, and clinical databases based on protocol requirements.
Ensure timely and accurate completion of clinical study data forms and documentation.
Verify study data for accuracy and completeness while identifying and resolving discrepancies.
Generate, manage, and track data queries to ensure data integrity across clinical studies.
Assist with compensation processing and resolve discrepancies related to study payments when required.
Clinical Documentation Management
Create, organize, and maintain clinical study files in accordance with regulatory and internal requirements.
Manage the distribution and tracking of essential clinical trial documents.
Support periodic audits and quality checks of clinical study documentation to ensure completeness and compliance.
Operational and Administrative Support
Provide administrative and operational support to clinical research teams.
Assist in maintaining clinical trial documentation systems and internal records.
Coordinate internal communication related to study documentation and operational activities.
Quality and Compliance
Ensure all clinical study documentation and processes comply with regulatory standards, clinical research guidelines, and internal quality systems.
Identify potential documentation or data issues and escalate them appropriately.
Support internal audit preparation and compliance verification activities.
Role Characteristics
Autonomy and Work Environment
Operates as an established individual contributor within the clinical operations support framework.
Performs administrative and operational tasks requiring prior experience and understanding of clinical research processes.
Works under moderate supervision with the ability to make minor adjustments to methods and procedures when necessary.
Organizational Impact
Contributes to daily clinical study operations and administrative functions.
Ensures accuracy and timeliness in documentation and data management processes that directly impact study timelines and operational efficiency.
Problem Solving and Process Improvement
Identifies routine issues in documentation or data workflows and implements minor process adjustments to improve efficiency.
Highlights operational challenges and proposes practical solutions within the assigned area of responsibility.
Communication and Collaboration
Communicates regularly with internal teams including clinical operations, research coordinators, and administrative departments.
Provides and gathers information requiring explanation, interpretation, and coordination across teams.
Mentorship Support
May provide guidance and assistance to new or entry-level employees joining the clinical support team.
Required Skills and Competencies
Clinical Research Knowledge
Understanding of clinical trial documentation, case report forms, and clinical data management processes.
Familiarity with clinical research regulations, documentation standards, and study protocols.
Data Accuracy and Attention to Detail
Strong analytical and verification skills to ensure accurate data capture and documentation.
Organizational and Administrative Skills
Excellent document management and file organization capabilities.
Ability to handle multiple tasks and maintain high-quality documentation standards.
Communication Skills
Effective written and verbal communication skills for collaboration with internal teams and stakeholders.
Problem-Solving Abilities
Ability to identify discrepancies, analyze issues, and implement corrective actions within routine processes.
Education Requirements
Bachelor’s degree in Life Sciences, Clinical Research, Healthcare Administration, or a related field.
Experience Requirements
Minimum 2 years of relevant experience in clinical research, clinical operations support, data coordination, or healthcare administration.
Prior experience working with clinical documentation, study databases, or research coordination is preferred.
Compensation and Benefits
Medtronic offers a competitive compensation package along with flexible employee benefits designed to support professionals at every stage of their careers. The company provides resources, professional development opportunities, and comprehensive benefits to promote employee well-being and long-term growth.
This role may also be eligible for the Medtronic Incentive Plan (MIP), a short-term performance-based incentive program.
Why Join Medtronic
At Medtronic, employees are part of a global mission to transform healthcare through innovative technologies and clinical advancements. Working at Medtronic offers the opportunity to collaborate with talented professionals, contribute to impactful medical research, and develop a rewarding career in the healthcare technology sector.
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