Sr. Clinical Data Associate (CDA) – Data Acquisition Specialist (Non-CRF)
Company: Syneos Health
Location: India – Remote
Job ID: 25110058
Department: Clinical Data Management / Clinical Solutions
Job Summary
The Sr. Clinical Data Associate (Data Acquisition Specialist – Non-CRF) is responsible for leading and managing Non-CRF data acquisition activities across global clinical trials. The role involves study setup, vendor data management, data transfer activities, validation, reconciliation, quality checks, and supporting Project Data Managers (PDMs) during study conduct and closeout phases.
The position requires strong expertise in external vendor data setup, non-CRF data workflows, central lab data, eCOA/ePRO, IRT/IWRS systems, data transfer agreements, and clinical database management processes.
Key Responsibilities
Non-CRF Data Management & Study Setup
Lead Non-CRF data collection activities during study startup, conduct, and closeout phases.
Perform assessment of all Non-CRF data types defined in study protocols and amendments.
Manage external vendor data setup, specifications, agreements, testing, and production data transfers.
Coordinate Non-CRF activities with cross-functional teams and external vendors.
Act as the Non-CRF Point of Contact (POC) for clients and study teams.
Ensure successful receipt, processing, validation, and delivery of Non-CRF test and production datasets.
Clinical Database Management Activities
Review and follow study-specific Data Management Plans (DMP).
Support database setup activities including:
CRF/eCRF review
Database design specifications
Data structures
Annotated CRFs
Edit checks and validation specifications
Create and execute User Acceptance Testing (UAT) activities.
Perform testing of:
Data entry screens
Edit checks
Roles and permissions
Targeted SDV configuration
Study workflows
Perform post-migration testing for database changes.
External Data & Vendor Management
Manage integration and reconciliation of external data sources including:
Central and local laboratory data
eCOA/ePRO systems
Patient diaries
ECG data
Pharmacokinetic (PK) data
IRT/IWRS systems
Device and sensor data
Review Data Transfer Agreements (DTA), vendor specifications, and transfer plans.
Validate external datasets against clinical databases.
Identify discrepancies and coordinate resolution with vendors and stakeholders.
Data Review & Quality Control
Perform clinical database review and discrepancy management.
Review edit check outputs, validation listings, and data cleaning reports.
Apply self-evident corrections according to study guidelines.
Perform SAE reconciliation activities.
Conduct internal QC checks and maintain Data Management Study Files (DMSF).
Perform SAS mapping QC and document discrepancies.
Support audits, inspections, and quality reviews.
Team Leadership & Collaboration
Lead and mentor Clinical Data Associates (CDAs).
Review work performed by junior team members and provide feedback.
Train internal teams on study-specific requirements.
Conduct EDC training sessions for internal and external stakeholders.
Act as a Subject Matter Expert (SME) for DM platforms and processes.
Support Project Data Managers with study metrics, reporting, and sponsor communication.
Required Qualifications
Education
Bachelor’s degree in Biological Sciences, Healthcare, Life Sciences, or related field.
Experience
5–7 years of experience in Clinical Data Management.
Strong experience in Non-CRF data setup and external vendor data management.
Experience working on global clinical trials.
Experience with clinical data review, validation, and reconciliation processes.
Technical Skills Required
Clinical Data Management systems knowledge:
Oracle Clinical
Medidata Rave
Inform
Experience with:
Central laboratory data management
eCOA/ePRO systems
Patient diaries
Device/sensor testing
ECG data setup
IWRS/IVRS/IXRS testing
Data Transfer Agreements
External data integration
Knowledge & Competencies
Understanding of ICH-GCP guidelines and clinical research processes.
Knowledge of medical terminology.
Strong understanding of clinical trial lifecycle and drug development processes.
Excellent communication and stakeholder management skills.
Ability to manage multiple priorities under strict timelines.
Strong analytical, organizational, and problem-solving skills.
Ability to work independently and lead cross-functional teams.
Experience Required (1-Line Summary)
5–7 years of Clinical Data Management experience with strong expertise in Non-CRF data acquisition, external vendor data setup, central lab integrations, eCOA/ePRO, IRT/IWRS testing, database validation, and global clinical trial support.
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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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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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 :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Boulder | Denver | Westminster |Connecticut :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Hilo | Honolulu |Tennessee :
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Lisbon | Oeiras | Portugal |WI :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
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Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Yavne | Be'Er Sheva | Netanya | Tel Aviv | Kfar Saba |Remote :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Singapore |Sofia City :
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