Require Clinical Data Analyst at PAREXEL
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Clinical Data Analyst III
The Clinical Data Analyst III (CDA III) shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.
The CDA III may act as a Data Management Lead where required.
Assume the ability to meet the requirements of a CDA I and II with a high degree of proficiency
• Lead/Responsible for data cleaning and data review activities e.g. query management.
• 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 CRFs. Support data entry where required.
• Perform and or support the setup of DM documents and ensure proper documentation.
Perform/lead functional QC activities and testing
• Mentor project team members
• Be a subject matter expert when needed
Personal skills that include:
* Good interpersonal, oral and written communication skills
* Excellent learning ability
* Work with integrity
• Business / Operational skills that include:
* Commitment to quality
* Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
* Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
• 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 SOPs 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
Job ID : 58308BR
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Hyderabad, Telangana
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Data
End Date : 25th January, 2020
See All Other Jobs in our Database