CTA-ClinOps
Company: Syngene
Location: Bangalore, India
Job Type: Full-Time
Experience: Relevant clinical trial experience (CRC preferred)
Qualification: M.Sc / M.Pharm / PharmD / BAMS / BDS / MDS / BHMS / Life Sciences
Job Overview
The CTA-ClinOps role supports clinical trial operations by assisting Clinical Study Managers and CRAs in documentation, trial coordination, and clinical systems management. The role focuses on ensuring accurate tracking, compliance, and smooth execution of clinical studies.
Key Responsibilities
Clinical Trial Support
Assist CSM and CRA in managing clinical trial activities
Support planning, scheduling, and coordination of study visits
Document Management
Maintain Trial Master File (TMF) and Investigator Site Files (ISF)
Ensure proper filing, tracking, and archiving of study documents
Perform quality checks for accuracy and completeness
Regulatory & Compliance
Support regulatory and ethics committee submissions
Track approvals and study start-up milestones
Ensure compliance with GCP, SOPs, and regulatory guidelines
Data Management
Track CRFs, queries, and clinical data flow
Maintain logs, trackers, and clinical trial databases (CTMS)
Support study status reporting
Communication & Coordination
Act as central contact between sites, vendors, and internal teams
Manage study-related communications and documentation
Trial Supply Management
Coordinate shipment and tracking of study supplies and investigational products
Maintain inventory and reconciliation records
Audit & Inspection Support
Prepare documentation for audits and inspections
Assist in resolving findings and follow-up actions
Administrative Support
Assist in document preparation, filing, and archiving
Support team with operational and administrative tasks
Required Skills
Clinical trial coordination and documentation knowledge
Understanding of GCP and regulatory guidelines
Strong communication and coordination skills
Attention to detail and data accuracy
Ability to manage multiple tasks and deadlines
Preferred Skills
Experience as Clinical Research Coordinator (CRC)
Knowledge of TMF, CTMS, and CRF handling
Exposure to audits and regulatory submissions
Key Competencies
Organization and time management
Problem-solving and adaptability
Team collaboration
Compliance-focused mindset
Attention to detail
About the Company
Syngene is an innovation-driven contract research, development, and manufacturing organization providing integrated scientific services from early discovery to commercial supply.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Concord | Lumberton | North Carolina |Michigan :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Hilo | Honolulu |Tennessee :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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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 :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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 :
Renfrew | Mississauga | Richmond Hill | Australia | North York | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |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 :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Riyadh | King Abdullah Economic City | Jeddah | Khulais | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
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