Job ID 9085
Career Level Executive
Experience 2 Years
Category / Function Management
Qualifications Degree Bachelor
Senior Clinical Data Associate – Technical Designer
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
- 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 – we’re able to create a place where everyone feels like they belong.
This position is responsible for providing focused expertise and full responsibility for database build and set up.
- Responsible for executing all study build activities for the assigned projects.
- Ensures the contracted start up activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor’s expectations. The scope may include projects that are large and/or complex and/or with particular challenge
- This position is responsible for coordinating with other technical designers (TD) in all start up and build activities, providing support.
- Attends Client Study Start-up Kick-off meeting
- Participates in internal meetings, including UAT Kick-off meeting.
- Attends in-process review meetings. Attend and present CRFs in the eCRF walkthrough meeting to the client.
- Creates/Reviews Study Build timelines and provide inputs as applicable to the PDM.
- Exhibits thorough knowledge and interpretation of the study protocol for Study startup activities.
- Creates and/or reviews database design specifications (including configuration, data structures, annotated CRFs).
- Designs and/or reviews CRF/eCRF, Matrix Design document (MDD) including eCRF visit structure cocoordinating with team members responsible for the associated database design.
- Create the Study Logic and Configuration Specification (SLACS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance.
- Creates, updates and reviews study-specific documents such as CRF/eCRF Completion Guidelines, Spotfire visualization specifications (SVS), Study Configuration Document (SCD).
- Supports, maintains and utilizes Data Standardization of eCRF and eCRF modules, data collection, data quality rules, data libraries and dictionaries in conjunction with inputs from other functional teams and project teams in accordance with CDISC standards
- Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations.