Clinical Data Analyst

ApicalGo Consultancy
Experience: 1 - 4 years
CTC Offered: Not Disclosed
Locations: Bengaluru
Details
Job description PRIMARY PURPOSE : - The Clinical Data Analyst has responsibilities for providing technical support activities for clinical research studies and coordinates with internal project staff and clinical sites on all aspects of study compliance and data collection. PRIMARY RESPONSIBILITIES : - Provides data management and operational support for a protocol or group of protocols. - Possesses detailed knowledge of the protocol and its associated activities and timelines - Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol. - Designs and develops electronic case report forms (eCRFs) and is responsible for the testing and validation of study-specific electronic data capture (EDC) systems. - Reviews, implements, and evaluates validation processes (Integrity andor other methods). Generates queries, produces and distributes anomaly reports and resolves data discrepancies. - Prepares and reviews study and project materials, (e.g., Manual of Operating Procedures (MOPs), User's Guides, - Data Management Handbooks, and Standard Operating Procedures (SOPs). - Participate in site update calls and sponsor calls, as needed. - Performs quality assurance activities for interim and study-close out database locks. - Attends and participates in project and functional group meetings. - Performs data entry as necessary. - Support project statistician to review project-specific reports, as needed. - Helps to create and maintain documentation on all data-related activities in alignment with project-specific and corporate SOPs. - Ensure accurate, effective and timely communication of study status and discrepancies to senior members of the team - Performs internal data audits and other project quality assurance activities and documents processes as required by corporateproject SOPs. - Participate in corporate QA meetings with the Internal Quality Audit Team (IQAT), ensure adherence with project- specific SOPs and compliancevariance table, and participate in internalexternal audits, as required. - Ensure adherence to GCP and ICH guidelines. - Assists with the orientation of new personnel. EXPERIENCE : 1 - 4 years of related experience EDUCATION : Master's degree in health-related field EXPERIENCES AND COMPETENCIES : - Strong data management and computer skills - Self-motivated and detail oriented - Excellent oral, written and interpersonal communication skills - Skills in prioritization, time management and planning - Good understanding of GCP principles and other regulatory standards in Clinical Research . - Ability to work independently, as well as in a complex team environment Location : Bangalore Candidates from Bangalore only. RoleClinical Research Associate/Scientist Industry TypeIT-Software, Software Services Functional AreaMedical, Healthcare, R&D, Pharmaceuticals, Biotechnology Employment TypeFull Time, Permanent Role CategoryR&D Education UG :Any Graduate in Any Specialization PG :Any Postgraduate in Any Specialization Doctorate :Doctorate Not Required Key Skills technical supportMedical ApplicationsData ManagementData AnalystClinical Data ManagementMedical Imaging
ApicalGo Consultancy
Role: Clinical Research Associate/Scientist
Department: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Graduation Required: Any Graduate in Any Specialization
Post Graduation Required: Any Postgraduate in Any Specialization
Doctrate Required: Doctorate Not Required
Industry:
IT-Software Software Services
Employment Type:
Full Time Permanent
Keyskills:
technical support Medical Applications Data Management Data Analyst Clinical Data Management Medical Imaging