Parexel hiring for clinical data analyst
Clinical Data Analyst I
Bengaluru, Karnataka, India
Job ID R0000020031
Category Data Management
The Clinical Data Analyst I
The Clinical Data Analyst I works under guidance and supervision of their Line Manager and/or Subject Matter Experts to perform some of the clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities, Data Management documents and data cleaning matrices e.g. Data Validation specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shell for Off-line listing, etc.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
Data Validation (cleaning):
Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA), e.g. query management and manual/SAS listing reviews.
Support/start to lead data processing activities from database setup to database lock, e.g. external vendor data reconciliation.
Data Management Documents/Plans (Trial Master File):
Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT):
Start to lead/perform user acceptance testing on clinical database setups.
Start to review protocols and EDC Entry Screens if required.
Data Tracking and Entry:
Track and review CRFs. Support data entry where required.
Project Quality Management & Compliance:
Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
Support/start to lead functional QC activities on databases and/or patient data, as per business needs.
Training:
Maintain training compliance as per Job Roles assigned, including On-the-Job training.
Address training needs, as per Development Goal/s identified.
Skills:
Evidence of strong problem-solving skills and logical reasoning
Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail)
Time management and prioritization skills in order to meet objectives and timelines
Evidence of ability to work collaboratively within a team environment
Good interpersonal, oral and written communication skills
Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments.
Evidence of accountability relative to Key Accountabilities in Job Description
Written and oral fluency in English
Location: Office based- Bengaluru, Hyderabad, Mohali, Chandigarh
Education:
Bachelor’s degree and/or other medical qualifications or relevant industry experience
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