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Lab Data Specialist in South Africa

Employer
Syneos Health
Location
South Africa (ZA)
Salary
Competitive
Start date
3 Nov 2020
Closing date
3 Dec 2020

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Job Details

Lab Data Specialist

Bloemfontein

South Africa

 

Here at Syneos Health we are currently recruiting for a Senior Clinical Data Associate to be office based in Bloemfontein, South Africa.  For this opportunity we are looking for Lab Specialist experience and strong knowledge about Lab Normal Ranges.


Responsibilities for this role are as follows:

 

  •  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..

 

Eligibility/Qualifications/Requirements

 

The ideal candidate will need the following experience / skills to be considered:

  •  5+ years experience as a Data Associate
  • Experience working with Inform

  • Experience working in the clinical research industry within a CRO/Pharma/Site

  • Experience collaborating with a study team

 

  • Bachelor’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and

    experience.

  • The ability to deal effectively with sponsors and internal customers at all levels

  • Excellent communication and interpersonal skills, both written and spoken, with an ability to

    inform.

  • Demonstrated experience in managing multiple priorities in a highly dynamic environment

  • Experience working in a matrix-structured environment is preferred

     

  • *Preference will be given to those from previously disadvantaged groups that meets the minimum requirements of the position

     

 

We have a comprehensive benefits package and offer highly competitive remuneration.


If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.

 

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

 

Disclaimer:
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. 

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