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) 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 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)
🏢 The Pharma Daily - Powered by Vigisolvo
📍 Kolkata