Sr CDA (Data Acquisition Specialist-Non-CRF)

inVentiv Health Clinical SRE, LLC; Pune District; On-site; INR 900,000 - 1,600,000; Full time

Job summary

Syneos Health in Pune is seeking a Senior Clinical Data Acquisition Specialist (Non-CRF) to lead CDAs in data collection across study phases, ensuring data integrity and timely delivery.

You will perform UAT, manage data entry screens, edits, SDV configuration, and support audits while supervising junior CDAs and coordinating with PM/BPM teams.

Qualifications

• Leading CDAs in collection of Non-CRF data during study set-up, conduct and closeout.
• Performs UAT and validation for data entry screens and SDV configurations.
• Ensures data quality and manages queries and discrepancies.
• Supports audits and documentation in the Data Management Study File (DMSF).

Responsibilities

• Leads other Clinical Data Associates in data collection for multiple studies.
• Reviews study-specific DMP and updates as required.
• Performs UAT for data entry screens, edits and SDV configurations.
• Resolves data queries and ensures CRFs/DCF alignment during paper studies.

Skills

Clinical Data Management

SAS mapping QC

UAT testing

PM/leadership

Education

Bachelor's degree in Life Sciences

Tools

CDMS

EDC systems

SAS

Job description

Description Sr CDA (Data Acquisition Specialist-Non-CRF)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health

Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program.We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - were able to create a place where everyone feels like they belong.

Job Responsibilities

Job Summary

This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials.

Core Responsibilities

• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary.


• Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required.


• Creates and enters test data for User Acceptance Testing (UAT)


• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.


• Receives and enters lab normal ranges.


• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.


• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects.


• Resolves answered queries and re-queries where appropriate.


• For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly.


• For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.


• For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.


• For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems.


• Participates/Leads in internal meetings.


• Attends in-process review meetings.


• Participates in internal/external audits as required.


• Files documentation in the Data Management Study File (DMSF).


• Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).


• Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.


• Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed.


• Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.


• Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload.


• Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to .