Clinical Data Associate II

Description

Clinical Data Associate II (Argentina Only - Remote)

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, you'll 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.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 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 – we're able to create a place where everyone feels like they belong.

Job Responsibilities

**Must be located in ARG with no sponsorship needs

**Please submit resume's in english.

 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.

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.

Summary

This position is responsible for assisting in all clinical data management activities required for clinical trialswith proficiency and by providing guidance to other Clinical Data Associates (CDAs).