CDA III

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

Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
 Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for
assigned project(s).
 Creates and enters test data for User Acceptance Testing (UAT)
 Performs User Acceptance Testing (UAT) for data entry screens, edits and assigned data review
listings, all different roles used in the study.
 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 in cases where
queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan
(DMP) for the assigned projects. Resolves answered queries correctly 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 Case Report Forms (CRFs) and database
accordingly. Submits copies of the DCFs to sponsors as necessary.
 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.

Creates electronic storage media per SOPs for Electronic Data Capture (EDC) studies.
 Participates in internal meetings and 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).
 Creates and enters test data for Standard Data Tabulation Model (SDTM) test data.
 Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
 May coordinate the work of CDAs assigned to the project.
 May provide training on data management activities and systems.
 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 take on
new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking
understanding of assignments prior to performing task and anticipating the effect changes may have
on data when issuing and resolving queries.
 Runs data cleaning and/or status reports.
 Performs Serious Adverse Event (SAE) reconciliations.
 Understands the coding process.
 Understands the purpose of interim, dry run, data cut.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.