CLINICAL STUDIES SPECIALIST COORDINATOR II
Company: Medtronic
Location: Mumbai, India (Remote)
Department: Clinical Research / Clinical Operations
Job Type: Full-Time
JOB OVERVIEW
The Clinical Studies Specialist Coordinator II supports the execution and management of clinical studies by coordinating clinical data, study documentation, study databases, and operational activities. The role ensures timely, accurate, and compliant management of clinical trial information while supporting study teams throughout the clinical research lifecycle.
KEY RESPONSIBILITIES
Clinical Data Coordination
Participate in development and testing of:
Case Report Forms (CRFs/eCRFs)
Clinical study databases
Study reports
Ensure protocol requirements are accurately incorporated into data collection systems.
Verify clinical study data for completeness and accuracy.
Generate, manage, and resolve data discrepancies.
Support data cleaning and reconciliation activities.
Maintain data quality and study compliance.
Clinical Documentation Management
Create and maintain clinical study files.
Organize and distribute study-related documentation.
Maintain Trial Master File (TMF) and study records.
Ensure documentation is inspection-ready.
Support document version control and archival processes.
Audit & Compliance Support
Conduct periodic reviews and audits of study files.
Verify document completeness and regulatory compliance.
Support internal and external audits.
Ensure adherence to:
ICH-GCP Guidelines
Clinical Study Protocols
Company SOPs
Regulatory Requirements
Study Operations Support
Coordinate study-related activities and timelines.
Track study progress and documentation status.
Assist with investigator and site communications.
Support study start-up, maintenance, and closeout activities.
Identify operational issues and recommend solutions.
Compensation & Financial Coordination
Process study-related compensation activities.
Investigate and resolve compensation discrepancies.
Maintain records related to study payments and reimbursements.
Administrative & Team Support
Provide operational and administrative support to clinical teams.
Assist with scheduling, tracking, and reporting activities.
Support onboarding and training of new team members.
Provide guidance to junior staff when required.
REQUIRED SKILLS
Clinical Research Skills
Clinical Trial Coordination
Clinical Documentation Management
Clinical Data Verification
Study Database Management
CRF/eCRF Review
GCP Compliance
TMF Management
Audit Readiness
Technical Skills
Clinical Trial Management Systems (CTMS)
Electronic Data Capture (EDC)
Microsoft Office Suite
Excel
Word
Clinical Databases
Document Management Systems
Soft Skills
Attention to Detail
Organization Skills
Time Management
Problem Solving
Communication Skills
Team Collaboration
Documentation Accuracy
Multitasking
EDUCATIONAL QUALIFICATIONS
Preferred Degrees
B.Pharm
M.Pharm
B.Sc Life Sciences
M.Sc Life Sciences
Biotechnology
Nursing
Clinical Research
Biomedical Sciences
EXPERIENCE REQUIREMENTS
Minimum 2 years of relevant clinical research or clinical operations experience.
Experience in:
Clinical data coordination
Clinical documentation management
Study file maintenance
Clinical trial support activities
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
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Rostock |Saarland :
Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Uxbridge | Mississauga | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Kfar Saba | Netanya | Yavne | Tel Aviv | Be'Er Sheva |Remote :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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