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- 1. Mr. Sagar Kalidas Paulkar Date of Birth: 31st Dec 1982 Address: c/o Mr D V Shitole’s House, Contact: +91 9922774123 Survey No 47, Sankalp Society Lane Email: sagarpaulkar@gmail.com No: 1, Sunita Nagar, Wadgaonsheri, Pune 411014 Education Qualifications: • Master of science (Bio-Chemistry) • ACCR (Advanced Course in Clinical Research) • PDCR (Professional Diploma in Clinical Research) • Computer Hardware & Networking • MS-CIT Computer Skills: Languages: Java Operating systems: Windows XP, 7 & 8, Linux (Ubuntu) Other Skills: SQL, Microsoft Office, Selenium and Eclipse Version: Mars 4. Employment History: 1) Position Name : Clinical Test Engineer Organization Name : QA India (Work only for medrio inc). Company Description : Medrio provides web-based electronic data capture (EDC) and analysis software for clinical research which based on SAAS (Software as a Service) technology. Project Name : MEDRIO (Electronic Data Capture Software) Client : Medrio Inc. Domain : Health Care. Address :C1, Mantri Manor Housing Society, Lane No:5, Koregaon Park - 411001 Duration : 01 Mar 2012 to till date. Bug Software used : Eventum Version 1.7.0, Microsoft Visual Studio Team Foundation Server Version 11.0.50727.1 and Jira. CTMS (Clinical Trial Management System) related designing and testing: Profile: Identifying potential workflow and usability issues with new versions of Medrio’s EDC service. Designing realistic test trial designs covering a wide variety of clinical trial study designs. Managing Medrio’s library of test study designs and driving the adoption of realistic study designs throughout testing processes. Acting as the liaison between the India Software QA staff and the San Francisco Software Test, Product Management and engineering groups. Key Responsibilities: Regression testing, Validation and Training of new colleagues. • Testing of configuration related to electronic case report forms with different requirements of specialized setting i.e. queries, randomization, ePRO, blinding / unblinded, form Rule, Electronic Signature, Coding Dictionaries and ODM import and export etc. • Testing Analysis of data with the help of variables by standard methods of Biostatics - Box plot / box and whisker, Descriptive statistics and p value, Regression analysis, Scatter plot etc. Page 1 of 4
- 2. • Testing of coding the adverse events and drug names as per standard coding dictionaries i.e medDRA, WhoDrug. • Educating the QA team on the clinical trials workflows and processes that Medrio’s software supports. Deliver various trainings on new and critical functionalities like Randomization, Drug Coding and Analysis to all developers and testers. • Ensuring that all work performed is done in accordance with operating procedures and industry guidelines/regulations. • Performing manual testing, Functional and Non-functional, Regression and defect life cycle on web base application. Converts test cases into script using Keyword Driven format • Creation, Execution, Development, Update of test plans & test cases. Reporting/Tracking and updating defects in Eventum, TFS and Jira. • Mostly work as domain expert (Health care – Clinical Research) 2) Position Name : Clinical Research Coordinator Organization Name : Ruby Hall Clinic Services Pvt Ltd. Company Description : Ruby Hall Clinic Services Pvt Ltd. branched from Ruby Hall Clinic provides clinical research services for clinical Research Organisation and pharmaceutical companies Project Name : Clinical Research Trials Clients : Confidential Domain : Health Care. Address : Ruby hall Clinic, 40, Sassoon Road, Pune- 411001 Duration : 16 Oct 2008 to 29 Feb 2012 Clinical Operations: Profile: Conduct multiple oncology trials simultaneously with other indications. Monitoring the project activity, schedule training visits required for different trials, and maintaining training records. Most importantly; up to date documenting relevant trial related course of actions. Coordinate the clinical trial strictly according to the ethics and confidentiality Key Responsibilities: Clinical Trial Management at Site level. • To carry out patient trial procedures as per the client protocol and analyse reports to decide the eligibility for the trial • Use of IVRS and IWRS for recording data of visits and drug dispensing. Source Documentation & Case Report Form Completion (Paper and Electronic) for respective patient visit. • Communications with PI, patient, Ethics Committee and sponsor representative. Maintaining Site Master File and update it regularly. • Working on various types of eCRF i.e. Medrio, Inform, PDS EDC, Medidata, Data Capture etc. • Reporting and co-coordinating of SAEs in specified time lines and updating it regularly • Investigational Product dosing, it’s accountability. Data Clarification / Data Queries resolution • Assist to CRA for their respective visits and audits works during the clinical trial studies. • Works on financial part of study i.e. Preparing Invoices for study and Invoices for patient for their expenses. Page 2 of 4
- 3. Clinical Research Training Details: Extensive training on various aspects of clinical research, e.g. study initiation, conduction & closure, clinical trial monitoring, project management, creation of standard operating procedures, investigator site selection, informed consent process, ethics review board, deviations & violations, randomization, blinding & Unbinding, Pharmacovigilance, data management, drug accountability & management, regulatory compliance, auditing & quality assurance, medical writing etc. Clinical Research Experience Details Ongoing at the time of resignation: • A Phase 3, Randomized, Double-Blinded Study of IP in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression. • A Phase 3 Multicentric, Randomized, Placebo-controlled, Double-blind Study of IP for Moderately to Severely Active Ulcerative Colitis. Quality Management Audit Cleared • A phase III, randomized, comparative, open label study of IP in inflammatory bowel disease subjects with iron deficiency Anaemia. • A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of IP in Adult Patients with Solid Tumor or Hematologic Malignancy. • A phase II, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of IP for 12 weeks in adults with moderate to severe chronic obstructive pulmonary disease (copd). Closed: • An Open Label, Comparative, multicentric study of IP in patients scheduled for diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract • Open label, multimember phase I study of IP for advanced refractory malignancies. – Internal Audit Cleared- Internal Audit Cleared • A Multicentric, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III study of IP for Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy • A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study of IP in patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer under fed condition. - Internal Audit Cleared • A 12-month, randomized, double-blind, parallel group, active-controlled, multinational, phase III study of IP in asthmatic patients aged 16 years and above. – Quality Management Audit Cleared • A Multinational, Multicentric, Randomized, Double Blind Study of IP for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery. • A multicenter, prospective, open label study of the safety and efficacy of IP in Indian patients with symptomatic osteoarthritis of the knee(s) after initial and repeat treatment. • A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study of IP for Moderately to Severely Active Ulcerative Colitis.- Quality Management Audit Cleared • Double Blind, Double Dummy, Multicentric Randomized Phase III Study of IP for Moderate Ulcerative Colitis - Internal Audit Cleared • Phase 1/2 Study of IP for Patients with Favorable-Prognosis Inoperable Stage IIIA/B Non Small Cell Lung Cancer (NSCLC) • A Double Blind, Randomized Controlled, Efficacy and safety study of IP in symptomatic treatment Osteoarthritis knee: - Internal Audit Cleared • A Phase II safety and Efficacy study of IP in patients with Diffuse Large B-Cell Lymphoma following Autologus Stem Cell Transplantation. Page 3 of 4
- 4. Attended Investigator Meeting: • Mumbai –Recurrence of Multiple Myeloma after bone marrow transplant – Oct 2008 • Chennai – DVT Prophylaxis after Major Abdominal surgery – Aug 2009 • Delhi - IBD with Iron Deficiency Anaemia – Oct 2009 • Mumbai- Ulcerative Colitis – May 2010 • Singapore – Gastric Cancer / Gastroesophagal junction cancer – July 2010 • Bangluru – Gastric Cancer / Gastroesophagal junction cancer – Apr 2011 • Mumbai – Glioblastoma multiforme or anaplastic astrocytoma – Jun 2011 • Kaula Lumpur (Malaysia) – Solid Tumor malignancy / Haematologic Malignancy– Sep 2011 Declaration: I hereby declare that the above particulars are true to the best of my knowledge and belief. Sagar Paulkar Clinical Test Engineer Page 4 of 4