Sudeep Gowda Email and Phone Number

• Data Operations Coordinator (DOC) for 3 projects with more than 5 operations staff.• Back-up to a Data Team Lead and Line Manager.• Complied with core operating procedures and work instructions.• Validated programmed edit checks for paper-based and EDC studies.• Validated SAS datasets for Data transfer programming.• Validated edit checks that are programmed outside of the system (e.g., SAS listings)• Reconciled Serious Adverse Event (SAE)• Performed Quality Control… Show more • Data Operations Coordinator (DOC) for 3 projects with more than 5 operations staff.• Back-up to a Data Team Lead and Line Manager.• Complied with core operating procedures and work instructions.• Validated programmed edit checks for paper-based and EDC studies.• Validated SAS datasets for Data transfer programming.• Validated edit checks that are programmed outside of the system (e.g., SAS listings)• Reconciled Serious Adverse Event (SAE)• Performed Quality Control (QC) procedures for paper-based studies• Participated in start-up, conduct and database lock activities.• Created and authorized project specific guidelines and Process instructions.• Worked on start-up activities for both paper-based and EDC studies.• Manage all phases of data management activities from study start up to database close, which may include:Test data creation & UATPerforming/ leading functional QC activities and testingData validation and cleaningConduct medical coding if assignedConduct SAE & third party data reconciliationsPerform early and final database QC activitiesDatabase lock activitiesMaintaining Clinical Study Documents and archiving as appropriateResponsible for completeness, timely delivery and quality of clinical dataLead and coordinate other team members within the department on assigned studiesMentor project team members and be a subject matter expert when neededRepresent DM function in external client meetings and presentations such as investigator meetings as required.Facilitate cross functional team meetings both internally and externally as neededOther assigned responsibilities as needed Show less

Worked at client site GlaxoSmithKline as a Clinical Data Reviewer in Combination vaccine studies• Performs computerized and manual validation of clinical research data. Conducts pre-cleaning meeting to ensure that all essential information for data review is available and also performs coding of the medical terms in the clinical data using standard dictionaries• Generates Data Queries during discrepancy management and coordinates their resolution through trial site staff and… Show more Worked at client site GlaxoSmithKline as a Clinical Data Reviewer in Combination vaccine studies• Performs computerized and manual validation of clinical research data. Conducts pre-cleaning meeting to ensure that all essential information for data review is available and also performs coding of the medical terms in the clinical data using standard dictionaries• Generates Data Queries during discrepancy management and coordinates their resolution through trial site staff and Interacts frequently with Clinical Research Associates who conduct the trials at the designated clinical research sites worldwide• Interacts extensively with the Clinical Data Coordinator, the Study Specific Programmer and the Database Administrator in facilitating the timely closure of a cleaned clinical research database of errors, missing information, discrepancies with appropriate audit trail and delivers them for statistical analysis• Capable of handling 8 to 10 Clinical/vaccine studies simultaneously with equal proportions of computerized and manual cleaning. Flexibly manages data cleaning processes for complex study designs and processes• Support programmers in developing data validation programs for non-standard studies. Checks completeness of the cleaning material pertaining to the function and archives them• Worked on setting up the data management process, reviewed and prepared SOPs, Guidelines, Project Metrics document, Job description, QA process documents, SAE process documents, CRF templates, and DM checklist for a project.• Worked on CRF designing and Edit Checks in excel format in Open Clinica community version application and also worked on CRF designing and Edit Checks in Medrio application.• Responsibility of Data Review QC of studies handled by peer CDRs. Performs the data entry QC.Involves in training new team members. Mentors and supports the CDRs in carrying their roles efficiently. Actively contribute to process improvement initiatives Show less

Progression Path:Clinical Data Manager (Nov 2008 - Aug 2010)Certified Data Validation Associate (OCT 2006 till OCT 2008)Data Validation Associate (Jul 2006 till SEP 2006)Ensure completeness and validity of the Clinical trial data As Value Creator: Propose improvements to work products, services/ processes & create re-usable solution.Was a supportive member of Clinical Project Teams for assigned projects and stand in for project lead Clinical Data Manager in case… Show more Progression Path:Clinical Data Manager (Nov 2008 - Aug 2010)Certified Data Validation Associate (OCT 2006 till OCT 2008)Data Validation Associate (Jul 2006 till SEP 2006)Ensure completeness and validity of the Clinical trial data As Value Creator: Propose improvements to work products, services/ processes & create re-usable solution.Was a supportive member of Clinical Project Teams for assigned projects and stand in for project lead Clinical Data Manager in case of absence. Project lead for 2 paper studies, handled 5-6 data managers and also Liaised with the CDPM to track the missing CRFs, resolve Lab and coding issues, and proposed Project specific guidelines.Proficiently worked on Musculoskeletal and Oncology Therapeutic Areas. Processed more than 50000 CRF Pages & successfully edited more than 10000 subjects/Patients data and integrated more than 5000 DCFs with 100% quality constraint.Have worked on phase 3 paper studies with duration of 3 years with enrollment of 5000 subjects and phase 3 EDC study with duration of 2 years with enrollment of 2000 subjects. As People Developer: lead/participate in people initiatives, build skills & assist others in completing their work. Collaborates with others within the organization in the review and evaluation of process improvements based on improved operations, methods or technology implementation. Mentored 3 data managers and completed their certification successfully.As Business Developer, maximize personal productivity, ensure high quality work products & processes and also meet deliverable requirements, service level measures & specific targets. Project lead for 2 paper studies, handled 5-6 data managers and also Liaised with the CDPM to track the missing CRFs, resolve Lab and coding issues, and proposed Project specific guidelines.Collaborates with others within the organization in the review and evaluation of process improvements based on improved operations, methods or technology implementation. Show less

I Co-ordinated a major International event called Bangalore-BIO-2006 (BIO.COM)