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Country Approval Specialist

3-5 years
Not Disclosed
10 Dec. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Studies Specialist Coordinator III – Mumbai, India

Location: Mumbai, Maharashtra
Position Type: Full-Time
Experience Required: Minimum 4 years of relevant experience
Job ID: R50837


About the Opportunity

Medtronic is seeking a Clinical Studies Specialist Coordinator III to support and advance its clinical research initiatives. This role offers an opportunity to contribute to high-impact clinical studies while working within a global healthcare technology leader dedicated to improving patient outcomes and expanding healthcare access worldwide.


Key Responsibilities

Clinical Data Coordination

  • Participate in the development and testing of Case Report Forms (CRFs), study databases, and study reports aligned with protocol requirements.

  • Ensure timely, accurate completion of study data forms.

  • Verify data quality and manage data discrepancies to maintain consistency and compliance.

  • Support compensation processing and resolve compensation-related discrepancies, when required.

Clinical Documentation Management

  • Create, manage, and maintain clinical study files and documentation systems.

  • Oversee distribution, version control, and organization of clinical study documents.

  • Assist with scheduled audits to verify completeness and regulatory compliance of study files.

Operational & Administrative Support

  • Perform a wide range of non-routine administrative and clerical tasks.

  • Support special projects and study-related activities as assigned.

  • Provide guidance and training to junior team members and low-level contributors.


Role Expectations

Autonomy

  • Functions as an experienced individual contributor working under limited supervision.

  • Expected to propose independent solutions for review and support process improvements.

Organizational Impact

  • Delivers essential daily operational tasks with significant contribution to overall study objectives.

  • Works with information that requires interpretation, accuracy, and timely execution.

Innovation & Problem-Solving

  • Implements minor procedural or system modifications to improve efficiency and effectiveness.

  • Identifies workflow challenges and supports proactive resolution strategies.

Communication & Collaboration

  • Communicates with internal and external stakeholders to obtain and provide essential study-related information.

  • Engages professionally on matters of moderate importance and complexity.

Leadership & Coaching

  • Offers training, mentorship, and task-level guidance to employees within the functional area.


Required Knowledge and Experience

  • Minimum 4 years of relevant professional experience in clinical research, clinical operations, or data coordination.

  • Broad practical understanding of operational systems, clinical documentation standards, and study management practices.

  • Strong organizational and analytical skills with the ability to manage multiple responsibilities.


Physical Job Requirements

This role may involve activities aligned with standard office-based responsibilities. Additional specific physical requirements may be communicated during the hiring process.


Benefits and Compensation

Medtronic offers:

  • Competitive salary structure

  • Flexible benefits package

  • Comprehensive resources and support across different stages of your career

  • Eligibility for the Medtronic Incentive Plan (MIP)

The company values employee contributions and ensures reward, recognition, and opportunity for growth.


About Medtronic

Medtronic is a global leader in healthcare technology, committed to solving the most complex health challenges. With a worldwide team of more than 95,000 professionals, Medtronic aims to alleviate pain, restore health, and extend life through innovation, engineering excellence, and a mission-driven culture.