Senior Clinical Data Coordinator (Senior CDC / CDC II)
Company: ICON plc
Location: Chennai / Trivandrum, India
Department: Clinical Data Management
Job Type: Full-Time
Work Mode: Office Based (Office With Flex)
JOB OVERVIEW
The Senior Clinical Data Coordinator (Senior CDC / CDC II) is responsible for managing and coordinating clinical data management activities throughout the clinical trial lifecycle. The role involves developing data management plans, ensuring data quality and integrity, resolving data discrepancies, coordinating with cross-functional teams, maintaining regulatory compliance, and mentoring junior data coordinators to support the successful execution of global clinical studies.
KEY RESPONSIBILITIES
Clinical Data Management
Develop and maintain Clinical Data Management Plans (DMPs).
Coordinate clinical data management activities across studies.
Ensure high-quality clinical trial data throughout the study lifecycle.
Maintain study documentation and data management records.
Support end-to-end clinical data management processes.
Data Quality & Validation
Identify and resolve clinical data discrepancies.
Perform data cleaning and reconciliation activities.
Monitor data quality and data integrity.
Ensure accurate and timely data collection.
Support continuous improvement of data management processes.
Cross-Functional Collaboration
Collaborate with Clinical Operations, Biostatistics, and Project Teams.
Develop study-specific data management strategies.
Support communication between internal stakeholders.
Participate in study planning and execution meetings.
Coordinate activities to ensure project milestones are achieved.
Study Documentation
Maintain study documentation in accordance with regulatory requirements.
File and archive clinical study documents.
Dispatch and track data queries to investigator sites.
Ensure documentation is complete, accurate, and audit-ready.
Support regulatory inspections and audits.
Clinical Data Review
Review clinical trial data for completeness and consistency.
Perform ongoing data reconciliation.
Support coding and query management activities.
Ensure timely resolution of investigator queries.
Monitor study data throughout the clinical trial lifecycle.
Mentoring & Leadership
Mentor junior Clinical Data Coordinators.
Provide guidance on data reconciliation and cleaning procedures.
Support team training and knowledge sharing.
Promote best practices in clinical data management.
Assist in improving team performance and operational efficiency.
Regulatory Compliance
Ensure compliance with ICH-GCP guidelines.
Follow company SOPs and clinical data management standards.
Maintain regulatory compliance throughout study execution.
Support quality assurance initiatives.
Ensure adherence to applicable industry regulations.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Life Sciences
Pharmacy
Nursing
Biotechnology
Biomedical Sciences
Clinical Research
Healthcare
Or a related scientific discipline
EXPERIENCE REQUIREMENTS
Required
Proven experience in Clinical Data Management within the pharmaceutical, biotechnology, or CRO industry.
Experience managing clinical trial data throughout the study lifecycle.
Hands-on experience with clinical data management systems such as Medidata Rave, Oracle RDC, or equivalent platforms.
Preferred
Experience mentoring junior Clinical Data Coordinators.
Experience in global clinical trials.
Knowledge of ICH-GCP guidelines and regulatory requirements.
Experience working in cross-functional clinical research teams.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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 | Uxbridge | Renfrew | 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 :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
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