Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Sr. Clinical Data Associate (CDA) – Data Acquisition Specialist (Non-CRF)

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Pharmacy data

Data

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.

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Computer Science

Jobs

Data Managers

Job

Drugs & Medications

Manage

Pharmaceuticals & Biotech 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. Sr. Clinical Data Associate (CDA) – Data Acquisition Specialist (Non-CRF)

Discover more

Pharmacy data

Data

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.

Discover more

Computer Science

Jobs

Data Managers

Job

Drugs & Medications

Manage

Pharmaceuticals & Biotech The position requires solid 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.

📌 Sr CDA (Data Acquisition Specialist-Non-CRF) (Kolkata Metropolitan Area)
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📍 Kolkata Metropolitan Area