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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | General / Other Software,Sales / BD |
| EmploymentType | Full-time |
Job Purpose:The Associate Clinical Data Analyst (ACDA) works under close 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, eCRF Completion Guidelines, etc.All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.Key Accountabilities:Data Validation (cleaning) - Responsible for data cleaning and data review activities, e.g. query management and manual/SAS listing reviews. Support data processing activities from database setup to database lock, e.g. external vendor data reconciliation.Data Management Documents/Plans (Trial Master File) - 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) - Perform User Acceptance Testing on clinical database setups.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 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.QualificationsSkills: Evidence of good 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 EnglishKnowledge and Experience: Evidence of technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills). Basic understanding/willingness to learn data management processes and data validation flow (e.g. Data cleaning, DB lock) Basic understanding/willingness to learn relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures Basic understanding/willingness to learn Clinical Study Team roles within Data ManagementEducation: Bachelor s degree and/or other medical qualifications or relevant industry experience,
Keyskills :
application servicesfinancial servicesplsqlsqlsqlsubject matter expertsuser acceptance testingstandard operating proceduresdata entrydata analysisclinical data