Bhavin P. Email & Phone Number

• Manage clinical trial data or data management projects under aggressive timelines, and in a high quality, professional manner, all while adhering to SOPs and work guidelines.• Oversee Clinical Data Management vendors to ensure vendors deliver quality work in a timely manner.• Create, review, and approve Data Management Plans (DMP) and all data management documentation, ensuring all study documents to be filed in the eTMF are ready for regulatory inspection.• Lead regular data review meetings in a cross-functional team environment.• Design and review eCRF specifications; create and review annotated eCRFs, and eCRF completion guidelines.• Oversee the design, creation, and testing of clinical study databases.• Responsible for adhering to Data Management timelines and budgets.• Create/oversee the development of data edit check specifications and manual data listings, as required.• Responsible for data cleaning, query and resolutions, review of medical coding, and database lock activities.• Responsible for external lab data reconciliation, the management and reconciliation of other external data, and the authoring of data transfer agreements.• Work with Safety and Pharmacovigilance (PV) to develop study specific Serious Adverse Event (SAE) reconciliation guidelines in order to reconcile SAEs.• Review and provide feedback on study protocols and cross functional study documents e.g. Clinical Monitoring Plans, Statistical Analysis Plans, etc.• Develop and review clinical data management functional processes, SOPs, and working instructions.• Cooperate and assist the Quality Systems department with quality control audits on assigned Clinical study databases.

Streamwood, Illinois, United States

• Interacts with internal and external project team members (including external data sourcevendors) for multiple projects, as appropriate. Actively contributes to study team discussions,standing meeting agendas, meeting attendance and review and/or documentation of minutes.• Ability to facilitate clinical database development to properly execute collection, receipt,reporting, review and archiving of quality clinical trial data. Includes eCRF planning discussions,coordination of eCRF review, planning and identification of system and protocol specific editchecks, coordination and proper execution of User Acceptance Testing, and coordination,planning and development for external data sources as needed.• Participates in early study team planning of data risk assessment and continuous evaluation ofrisks throughout course of study. Ability to offer insight or mitigate risks of data loss.• Communicate with assigned data team members to ensure tasks are coordinated and executedas per study plans and timelines as appropriate. Ensure training of study specific protocolrequirements as appropriate. Identify and communicate gaps in training and support training ofdata reviewers.• Ability to create, maintain, execute and properly store data related documentation as outlinedin department operation procedures and as required by study.• Responsible for functional area eTMF filing and quality control activities or equivalent as perstudy. Participation in internally and externally managed study audits as required.• Oversee study budget applicable to functional area. Identify and communicate potential out ofscope activities to project team as appropriate. Work with study team to provide neededinformation for re-scoping when applicable.• Responsible for proper generation, review and reporting of study metrics and financials asneeded.• Execute all tasks as aligned with SOPs, department guidelines and data standards.

Tesaro - A Gsk Company, Waltham, Ma

• Lead all data management responsibilities for Phase 3 Oncology study.• Experienced in handling data transfers and database migrations.• Reviewed Protocol for potential data collection, database structure, data entry problems andprovided feedback to the study team.• Extensively worked on developing the edit checks, data validation specifications, eCRFcompletion guidelines and writing test scenarios for performing User Acceptance Testing (UATs).• Maintained various issue logs (Lab delegation log, Errata log) and Trial Master Files (TMF) forstudy related documentation.• Efficiently maintained clinical study documents and archiving as appropriateness.• Reviewed database, data listings and CRFs to ensure all captured data follow the guidelinesoutlined by the protocol and data management plan.• Performed discrepancy management and generated queries to responsible personnel (sitemanagement or Clinical Research Associate) to resolve problematic data identified during everyaspect of data management process and reviewed responses to the queries for appropriateness.• Performed vendor data reconciliation.• Performed QC of lab normal ranges data entry to determine quality and clinically significant datafor the study related adverse events/serious adverse events.• Involved in multiple data cuts and data submissions and provided quality datasets for analysis.• Successfully locked database in given timelines for Interim Analysis.• Created and distributed study progress status reports such as Metric report, Enrolment reportto internal and external study team members.• Responsible for completeness, timely delivery and quality of clinical data.

Tesaro - A Gsk Company, Waltham, Ma

• Assists in preparing clean databases, including processing of discrepancies and queries Involvedin the preparation of the DMP.• Reviews CRFs, data listings, and database to ensure that all captured data follow the rulesoutlined by the protocol and data management plan.• Assists in developing a standard set of test data for use in testing data entry screens, data listingpresentation, and programmed logical edit checks, as required.• Prepares documentation noting the testing changes and performs follow-up testing to validatethat the changes have been made, as required• Participate in corporate initiatives and actions that ensure the continued success of thecompany.• Other activities as designated.

Cambridge, Ma

• Performed Protocol review and assisted in drafting data management plan (DMP) in co-ordination with study team.• Designed eCRFs in Medrio EDC in co-ordination with study team.• Prepared the Edit Check Specification document.• Programmed and performed User Acceptance Testing (UATs) of the Edit Checks in Medrio EDC.• Assisted in deploying test database to production and ensure all documentation is complete prior to go live.• Performed data cleaning activities such as, data review, generated queries, reviewed site response and resolved queries.• Prepared and distributed study progress reports to study team on periodic basis.• Performed duties as assigned for study and data management activities.

Boston, Ma

Tutoring of Biochemistry I subject for Pharm D students.

Gujarat, India

• Assisted in documentation for Quality Management System as per GMP requirement.• Assisted in documenting and resolving products non-conformance, providing CAPA and change control.• Involved in functioning of the entire QA/QC department.• Responsible for quality management and quality improvement.• Contributed in preparation of departmental Standard Operating Procedure (SOP), maintained records of analytical tests and procedures as per GMP.• Coordinated and reviewed documentation received from cross-functional team members for accuracy, completeness and to ensure compliance with applicable regulations and requirements.• Controlling and distribution of documents as and when required.

Gujarat, India

• Understood the functioning and basics of manufacturing area, the standard processes and control guidelines of good manufacturing practices. • Learned about Production, Research and Development and Quality Assurance responsibilities within the manufacturing facilities. • Prepared test solutions and reagent for conducting tests by laboratory personnel. • Reviewed various documents like, batch manufacturing records, results of the in-process quality control checks, certificate of analysis, packaging material specification, labeling specification. • Involved in different processes for production of solid drug dosage form like dispensing of active and non-active raw materials, wet granulation, blending, tablet compression, tablet coating, packaging and labeling of finished products as per Standard Operating Procedure (SOP).

Master Of Science (Ms), Regulatory Affairs And Health Policy, Gpa: 3.756

Knowledge of US FDA regulations as well as European, Canadian and Japanese regulatory requirements, Familiar with ICH, IRB, cGMP, GLP, GCP.

Master Of Pharmacy (M.Pharm), Quality Assurance, Gpa: 3.63

Working knowledge of lab techniques including UV-Visible spectrophotometry, IR spectroscopy, chromatographic techniques like HPLC, HPTLC.

Bachelor Of Pharmacy (B.Pharm.), Gpa: 3.58