Senior Clinical Data Analyst (Bloemfontein or Pretoria)
- Employer
- Parexel
- Location
- Bloemfontein, South Africa
- Salary
- Competitive
- Start date
- 27 Nov 2020
- Closing date
- 7 Dec 2020
View more
- Discipline
- Data Management / Statistics
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Job Purpose:-
* The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.
* Further responsibilities shall include acting as Study Team Lead, support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.
* The SCDA may act as a Data Management Lead where required.
Key Accountabilities:-
* Assume the ability to meet the requirements of a CDA III roIe with a high degree of proficiency and autonomy
* Lead/Responsible for data cleaning and data review activities e.g. query management.
* Management of project timelines (including creation, review and tracking of plans)
* Review of protocols and EDC Screens if required.
* Support data processing activities from database setup to database lock, e.g. SAE reconciliation.
* Perform user acceptance testing on study database setups.
* Perform medical coding on small studies
* Track and review CRF's. Support data entry where required.
* Perform and or support the setup of DM documents and ensure proper documentation e.g. CRF Completion Guidelines (CCG)
* Perform/lead functional QC activities and testing
* Mentor project team members
* Be a subject matter expert when neededQualifications
Knowledge and Experience:
* Experience in clinical research
* Good interpersonal, verbal and written communication skills
* Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)
* Ability to work in team environment
* Good analytical skills and attention to detail
* Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner
* Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures
* Good knowledge of EDC systems (e.g. DataLabs, Rave.)
* Good knowledge of electronic source data capture systems (e.g. ClinBase)
* Good knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
* Basic knowledge of SAS
Education:
* Bachelor's degree and / or other medical qualifications or relevant industry experience
Skills:
* Personal skills that include:
o Good interpersonal, oral and written communication skills
o Excellent learning ability
o Work with integrity
* Business / Operational skills that include:
o Commitment to quality
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11Why Work at Parexel
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.
Company
Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.
Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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