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# Key Responsibilities: Reviews the Data Management Plan and associated documents and provides relevant inputs to the checks, listings, cleaning plan etc. Adheres to the requirements of studyspecific Clinical Data Management Plans for assigned projects by reviewing & processing clinical trial data to ensure the accuracy & consistency of clinical databases Write and executes the validation plan of checksspecific listings when needed for an assigned studys as per the relevant SOP.
Analysing and resolving discrepancies identified by the programmatic checks within the eCRF system and during manual data review. Writing and posting data queries to sites for discrepant data, resolve answered queries and requeries where appropriate.
Ensures that data from external databasesdatasets such as central andor local laboratory data, electronic diary data etc. are consistent with data in the clinical database. Uses the specified reconciliation process to document and query any such discrepancies found with the appropriate party.
Coordinates and contributes to the data listings reviewmanual cleaning process as per the data listings review strategy, cleaning plan, study needs with relevant study stakeholders.
Contributes to the archival of documents in the eTMF relevant to the role Contributes to the process of database freeze, archival and provision of clinical data to the study site. Provides relevant data cleaning reports, status updates, feedback on trends throughout the study course. Provide inputs for development and enhancement of standard data checks and listing. Adhere to the relevant departmental SOPs, regulatory requirements and industry best practices.
Serves as a platform or processspecific Subject Matter Expert SME in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
Drives and supports process improvement initiatives. Trains and mentors peers by providing timely feedback to trainee and management as appropriate. Participates in internalexternal audits as required
Soft skills Good Written and Verbal English communication Focus, prioritizing, time management, multitasking Detail oriented, organized. Excellent interpersonal and team work skills. Agility towards change Problem solving mindset Quick learner Results oriented and customer focused Willing to work in a Global environment Coaching, mentoring Hard skills Excellent time management skills Experienced in Clinical Data Management processes, standards and clinical systems Experience working in Inform Exposure to Rave Veeva OC, eDiaries, eSource is an added advantage Proficient in Microsoft excel, visual basic and validation methodology.
Basic knowledge of PL SQL, SAS is an added advantage. Understanding of general data flow & database architecture concepts Good understanding of regulations including ICHGCP, 21 CRF part 11, CDISC requirement Comprehensive understanding of clinical drug Vaccine development process.
Knowledge of medical terminology, anatomy and physiology.
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