Sr CDA / CDA III (Data Acquisition Specialist)
Location: Pune, India (Hybrid)
Job ID: 25103264
Updated: November 12, 2025
Industry: Clinical Research / Data Management
Employment Type: Full-Time
About the Role
The Sr CDA / CDA III (Data Acquisition Specialist) plays a critical role in leading Non-CRF data acquisition and data management activities across multiple global clinical trials. This position supports the complete study lifecycle including setup, conduct, and closeout, ensuring high-quality, compliant, and inspection-ready data outputs. The role may also serve as a backup to the Project Data Manager (PDM).
This opportunity is with a globally recognized biopharmaceutical solutions organization dedicated to accelerating clinical development through innovative processes, strong technical expertise, and a patient-centric approach.
Key Responsibilities
Study Setup & Data Acquisition
Review study-specific Data Management Plans (DMP) and update as required.
Perform User Acceptance Testing (UAT) for data entry screens, edit checks, data review listings, targeted SDV configurations, and study roles.
Manage lab normal ranges and complete CDMS-specific access requests.
Oversee CRF/eCRF design, visit structures, and database configuration reviews.
Implement Non-CRF Vendor Transfer Agreements and ensure compliance with specifications.
Lead setup of IXRS/IRT UAT and support patient enrollment and randomization strategy.
Data Management & Quality Control
Conduct discrepancy reviews, apply self-evident corrections, issue and resolve queries per DMP and DVS requirements.
Perform QC checks for paper studies and EDC-based studies.
Lead reconciliation activities for external data sources such as labs, ECG, IRT, PK, eCOA, ePRO, and device/sensor data.
Execute SAE reconciliations and run data cleaning/status reports.
Perform SAS mapping QC and post-migration testing.
Maintain accurate documentation in the Data Management Study File (DMSF).
Project Leadership & Collaboration
Guide and review work of junior CDAs, providing mentorship and on-the-job training.
Act as Non-CRF point of contact, ensuring effective cross-functional communication and vendor coordination.
Participate in internal/external audits, in-process review meetings, and sponsor interactions.
Provide study metrics, ad-hoc data cleaning reports, and database design insights to project teams.
Support PDM in study-level deliverables including coordination with CDAs and presenting updates to sponsors.
Documentation & Reporting
Create, review, and update study-specific documents such as DMP, eCRF guidelines, data transfer agreements, and specifications.
Prepare Discoverer, BOXI, J-Review and other system-generated reports.
Prepare minutes for meetings and maintain timely communication with project stakeholders.
Required Experience & Qualifications
Education
Bachelor’s degree in Biological Sciences, Life Sciences, Health Sciences, or related disciplines.
Experience Requirements
Minimum 5–7 years of experience in Clinical Data Management.
Hands-on experience in Non-CRF data setup and external vendor data activities.
Experience in central lab data, eCOA, ePRO, patient diaries, sensors, device data, ECG, IWRS/IVRS testing, and external data transfers.
Prior involvement in data management study startup and study setup activities.
Technical Skills
Proficiency with clinical EDC systems such as Oracle Clinical, Rave, or Inform.
Knowledge of ICH-GCP guidelines and clinical data processes.
Understanding of medical terminology.
Strong skills in MS Word, Excel, and Windows-based tools.
Strong keyboard accuracy and speed.
Experience with relational database management systems is preferred.
Soft Skills
Excellent verbal and written communication skills.
Strong presentation and interpersonal abilities.
Effective time management, task prioritization, and attention to detail.
Ability to work independently and within a cross-functional environment.
Strong mentoring and leadership capabilities.
Additional Requirements
Ability to handle multiple projects under tight timelines.
Flexibility to adapt to shifting priorities.
Willingness to participate in audits and business development meetings if required.
Minimal travel may be required (up to 25%).
Why Join This Organization
Work with a global team spread across 110 countries.
Part of an organization involved in 94% of Novel FDA Approvals in the past five years.
Strong focus on professional development, training, and technical growth.
Supportive Total Self culture fostering authenticity and inclusion.
Summary
The Sr CDA / CDA III (Data Acquisition Specialist) is a senior-level data management role responsible for ensuring the accuracy, completeness, and compliance of Non-CRF and external clinical data. This role requires strong technical expertise, leadership capabilities, and the ability to collaborate effectively with global stakeholders, vendors, and cross-functional teams.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Tartu | Estonia |Harju County (Maakond) :
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Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
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Prague |Chile :
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