Yogesh Dalvi Email & Phone Number

At Accenture currently working as PDM•For Study meeting preparing slides for DQST and Global team meeting with entire study Data Management Status; Monitors and communicates, escalating project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection for missing pages, query status, Uncoded terms, pending SDV /PI sign, Freeze/Lock form status, External Data issues, SAE Reconciliation, Subject Status, PDRP review etc.• Coordinate and allocate the work of the assigned Data Management• Timeline preparation for PPC/Migration, Final DBL for various study and meeting timeline with quality.Ensures launch, delivery and completion of all Data Management activities and milestones like Migration, Final DBL, CPG, Survival Sweep according to agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations• Worked on PDM Listing Review, Audit Trail Review, DRA Filling ,Unlock/Unfreeze request, Tracking follow up with site facing roles CTM via metrics etc.• Provides project specific training, various task to DM team as and when required, Plan, manages and requests resources for assigned projects• Preparing of study documents like eCCG,PDRP,DQMP,• Trains and mentors data management staff on various study required or any new allocatio • Maintains all documentation on an ongoing basis and ensures that all TMF filing is complete and up to date and perform eTMF QC.• Participates in, and presents at internal DQST, Sponsor-Global Team Meeting, third-party meeting,PDM DM meeting, DML PDM meeting on weekly or monthly,ad hoc basis.Preparing MOM and documenting decision in Action and Decesion log• Site closure activity as per site closure tracker and sending PDR to sites after Closeout/Final DBL• Ability to make effective decisions and manage multiple priorities.• Strong project management skills and knowledge of project management methodologies• Ability to be flexible

Banglore

Hyderabad Area, India

I have worked on Data review and supporting this trial for activities like Manual Reviews, Discrepancy Management, Reconciliation and Review of Audit Trail Report etc.

Mumbai Area, India

I am well versed with all the processes and workflow of Clinical data management operations and good technical knowledge of CDM in conduct and closeout. Work on EDC and paper based clinical trials. I have sound knowledge and exposure to Clinical data management systems such as Inform, Oracle Clinical, RDC 4.6., OC 4.6.2.,SQL Work on various Clinical Data Management Activity•I have worked on extensively on Query management, Study specific Manual/Critcal listings reviews, Reconciliation of various records i.e., SAE reconciliation, MRI reconciliation, Lab data reconciliations, PK/PD reconciliation, AE-Concomitant medication reconciliation, review of clinical listings as per Medical reviewers checklist and review of Bio-statistical listings as per STATs critical checks, Peer QC. •Exposure of Data Base Lock/Data Base Freeze, Interim Analysis, Study timelines for various trial. Study Metrix Prparation, Closeout site tracker,Work on various tools like EXACT, Study explorer, SAS Checks. Protocol Deviation Reconciliation importance assigning as per PDMP Plan etc.•I work on a Multi centered study which is being conducted globally so have a good idea of various exposures related to handling of queries for specific countries, their guidelines, Coordinate with CRAs for timely resolution of queries etc. •Work as POC for lab reconciliation, SAE reconciliation which is one of the critical reconciliation•Generate queries to clarify and improve the quality of the data. •Prepare study documentation like Data review guidelines, Self- evident correction plan, CRF completion instructions etc. •Understand, provide input to and comply with all applicable sections of Data Management Plan. •Performed tasks like Query Management, Data Validation, SAE Reconciliation, Management and review of Important Protocol Deviations, Bio-statistical listings review, Clinical listing review and other study related ad-hoc listing review in Study conduct.

Mumbai Area, India

•I have worked on extensively on Query management, Study specific Manual/Critical listings reviews, Reconciliation of various records i.e., SAE reconciliation, MRI reconciliation, Lab data reconciliations, PK/PD reconciliation, AE-Concomitant medication reconciliation, review of clinical listings as per Medical reviewers checklist and review of Bio-statistical listings as per Stats critical checks, Peer QC. • I work on a Multi centered study which is being conducted globally so have a good idea of various exposures related to handling of queries for specific countries, their guidelines, etc. • Work as POC for lab reconciliation, SAE reconcilliation which is one of the critical reconciliation• Perform data management activities on the assigned project in a timely and efficient manner • Generate queries to clarify and improve the quality of the data. • Prepare study documentation like Data review guidelines, Self- evident correction plan, CRF completion instructions etc. • Update database with query resolutions. • Perform database User acceptance testing and Edit check User acceptance testing. • Perform Data Base audit as per QC plan. • Conduct basic quality control procedures. • Understand, provide input to and comply with all applicable sections of Data Management Plan. CRF and eCRF Completion Guidelines Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases. • Work on Phlex and share net portal to upload study documents and their QC.

Mumbai Area, India

ICMR Project.Ethic Committee submission,

Mumbai Area, India

 As a clinical researcher served in various capacities and worked on trials of several drugs and cosmetics (Phase I, II, III, and IV). Knowledge of ICH GCP, Schedule Y and Involved in:- Preparation of SITE MASTER FILE/TRIAL MASTER FILE for various projects. Site Initiation Visit (SIV),Interim Monitoring visit ,Final Clinical Study Report (CSR) Preparation according to Regulatory Guidelines (eg.ICH E3 Guideline) Overall management of the entire trial catering to all the issues related to subject enrolment, consent forms, dosage, and preparation of Adverse events, Serious Adverse Event , Protocol Deviation/Violation, EC Query letter related to EC submission, AE, SAE if any. Management and reporting of all the adverse events to sponsor, IEC and regulatory authorities.

Mumbai Area, India

 As a clinical researcher served in various capacities and worked on trials of several drugs and cosmetics (Phase I, II, III, and IV). Knowledge of ICH GCP, Schedule Y and Involved in:- Preparation of SITE MASTER FILE/ TRIAL MASTER FILE for various projects. Knowledge of submission of dossiers to Ethical Committee for approval. Designing study related documents Like Protocol Synopsis, Protocol, ICF, CRF, Investigators Undertaking, Clinical Trial Agreement and Investigators Brochure for various Projects. Site Initiation Visit (SIV), Investigator meets , Feasibility ,Interim Monitoring visit ,Final Clinical Study Report (CSR) Preparation according to Regulatory Guidelines (eg.ICH E3 Guideline) Preparation of CTD/eCTD(Common Technical Document) according to ASEAN and KSA Regulatory Guidelines (Module 4 & Module 5) Quality Control and support to Quality Assurance, SOP Preparation Site Initiation, Site Monitoring. Overall management of the entire trial catering to all the issues related to subject enrolment, consent forms, dosage, and adverse events, Serious Adverse Event if any. Ensuring confidentiality of trial subjects and integrity of trial data throughout the course of trial. Management and reporting of all the adverse events to sponsor, IEC and regulatory authorities. Training study staff in ICF and CRF filling requirement, coordinating various Clinical Trials etc.

Master Of Science - Msc, Bioanalytical Sciences

Bachelor Of Science - Bsc, Biotechnology