Sr CDA (FSP) - Min 5+ years of previous data management exp - Client Facing role - Argentina, h

Position: Sr CDA (FSP) - Min 5+ years of previous data management exp - Client Facing role - Argentina, h[...]
Sr CDA (FSP) - Min 5+ years of previous data management exp
- Client Facing role
- Argentina, home-based

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health We 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities This position is responsible for leading other Clinical Data Associates (CDA) in all data management activities, 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…