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Renu Singh-Mokashi

  • M.Sc. (Microbiology, Virology)
  • Clinical Research Manager
  • Indus Biotech Private Limited
  • 4Followers
  • 1Following

About

Ms. RENU SINGH- MOKASHI E-mail: renumokashi@gmail.com OBJECTIVE To be positioned within a global environment and have exposure to the global clinical research market and work alongside industry’s leading professionals. SPECIALTIES Over 3 years experience in medical and scientific writing in preparing Phase I to Phase IV Clinical Study Reports (CSR), Annual Safety Report (ASR), Clinical study protocols (CSP), Informed consent (ICF), Investigators’ Brochure (IB), Patient narratives, CTD summaries, Abstracts and others scientific support documents. Over 5 years working experience in clinical research industry. Over 4 years working experience in clinical monitoring as a CRA and last 3 years in clinical trial management including medical writing and project planning for in house and out sourced projects (phase I, II, III and IV) as lead manager. Exposure to critical aspects of the clinical development process of pharmaceutical products (NCE and Generics). Exposure to clinical and developmental regulations of US-FDA, EMEA, MHRA; ICH-GCP, Indian GCP and Schedule Y. Education Institution/University Degree Awarded Year Field of Study HPT Arts and RYK science College, Nasik, Pune University B.Sc. 2000 Science(Microbiology) Haffkine Institute for Training Research and Testing, Mumbai, Mumbai University M. Sc. 2005 Science(Microbiology and Virology) Academy for Clinical Excellence, Mumbai Diploma 2006 Clinical Research PROFESSIONAL WORK EXPERIENCE Manager Clinical Operations Karmic Lifesciences, Mumbai (May 2010- Sep. 2010) •Medical and Scientific writing and review: Responsible for writing and review of the CSR, Protocol, ICF, CRF, IB and training materials. •Clinical Operations and Project Management: Responsible for the satisfactory execution (timelines, budget, quality,) of projects being run by Karmic Lifesciences from their location(s). •Strategy Planning: Being manager of clinical operations; undertaking organization and capacity building; Developing yearly project goals, strategic plans, project budgets. Manage and provide constant support towards budgeting, resource planning and allocation with effective cost cutting measures •Business Development: Play a lead role in supporting the business development effort. Identifying market trends and opportunities; representing to clients visiting their location(s); providing input to business operations; attending conferences and congresses, preparation of Technical and business proposals for client, networking and liaising •Leadership & Personnel Management: Building and leading a cohesive and motivated team for successful project management. Management of internal project related clinical staff: Chalking a training plan, and ensure personnel development. Manager Clinical Research Indus Biotech Private Limited, Pune (2008- April 2010) Clinical trial management with project planning and medical writing for in-house and out sourced projects (phase I, II, III and IV) as lead manager. Instrumental in devising clinical trials in varied therapeutic areas (with special focus to Endocrinology, CNS, Metabolic Disorders, HIV, Cancer and Gastroenterology along with Sports Medicine and Geriatric Trials). • Medical and Scientific Writing: a.Protocol writing for • Oncology • Neurology • Endocrinology • Rheumatology • HIV and Infectious Diseases • Sports physiology b.Information Brochure writing c.ICF and CRF writing d.Clinical study report writing e.SOP writing f.Medical and promotional writing g. Research publication • Clinical Operations and Project Management- Responsible for the satisfactory execution (timelines, budget, quality,) of projects being run in whole or in part by Indus Biotech from their location(s) in following therapeutic areas: • Oncology- Double-blind, randomized, placebo controlled study to evaluate the safety and efficacy of IND02 as an adjuvant in breast cancer • Metabolic Disorders: • Pre Diabetes- A Prospective Double Blind Placebo Controlled Randomized Clinical Trial of Indus compound in Pre- Diabetic subjects • Obesity- To evaluate the effect of Indus compound on body fat mass. A prospective, randomized, double blind, placebo controlled, single center study in individuals with high fat mass • Type II Diabetes- Efficacy and safety of Indus compound in patients with Type II Diabetes Mellitus previously stabilized with oral hypoglycemic agent • Neuropsychiatry- Evaluation of safety and efficacy of Indus compound for the treatment of patients with Parkinson's disease • HIV- To assess the effect of Indus compound on CD4 count in HIV positive individuals. A prospective, double-blind, randomized, placebo controlled comparison in antiretroviral naive, asymptomatic HIV-1 infected patients with CD4 between 250-500/mm3 • Infectious diseases- Evaluation of safety and efficacy of Indus compound for the treatment of patients with Influenza A”, a double blind, randomized, phase II clinical trial • Rheumatology- An Open Label Single Centre Study to Evaluate the Efficacy and Safety of Indus compound in Patients with Rheumatoid Arthritis (RA) • Sports physiology: • The Effects of Indus compound on Strength, Body composition, and Hormonal Response to Resistance Training. • The Effects of Indus compound on Strength and Body composition, Executive Clinical Research Nicholas Piramal India Limited, Mumbai (Feb 2005-Dec 2006) •Writing and standardizing SOPs. •Managing and executing a pilot clinical trial for tropical herbal product on dermatophyte infections, in India (including Monitoring) •Monitoring Phase I trial of an Ayurvedic product in rheumatic patients across 5 centers in India •Managing and executing Phase I trial of an Ayurvedic product in Dermatology patients across 2 centers in India •Clinical Trial support to Phase I Anti Cancer Trial •Ensuring the receipt, completeness and accuracy of administrative documents, shipment of study related materials, •Making and maintaining the study files and related documents •Maintaining awareness of developments in the field of clinical research by reading relevant literature, reading SOPs, attending clinical team meetings and training programs. Audit Handling •In house and onsite audit handling for Rheumatic trial-by Clininvent- CRO •International Audit handling and document support to Eli Lily Audit RESEARCH EXPERIENCE Junior Research Fellow Department of Virology at Haffkine Institute for Training, Research and Testing (October 2000- March 2002) •On project, titled "Bio-efficacy and Immunogenicity testing of Purified Duck Embryo Vaccine (PDEV) in pre and post exposure cases", (Cadila Health Care ltd.) •On project titled” To study the role of Erythropoietin in HIV related anemia in HIV/AIDS patients”. CO-CURRICULAR ACTIVITIES •Faculty for conducting lectures and practical, in training around 240 under graduate students from and around Mumbai, for the Annual Biotechnology Summer Training program conducted by the Haffkine Institute. •Assisted the Head, Department of Virology in preparing lectures and Power point presentations for M.Sc., M.D., and PhD (microbiology) students for Annual Virology Course carried out by Mumbai University. PUBLICATIONS & PAPER PRESENTATIONS •Presented paper on PDEV, its bioefficacy and immunogenicity in pre and post exposure cases at XXVIth All India Medical Microbiologist Association, November 2002, Bangalore. •Presented and abstracted the paper titled, Correlation of TNF-alpha levels with morbidity and mortality in HIV/AIDS patients, XXVIIth All India Medical Microbiologist Association, Microcon, November 2003. •Immunogenicity and Bioefficacy study of Purified Duck Embryo Antirabies Vaccine (PDEV) in pre-exposure and post-exposure cases, APRICON, July 6&7 2002, Jaipur. •Immunogenicity and Bioefficacy Study of Purified Duck Embryo Vaccine (PDEV) manufactured by Cadila Healthcare Ltd. (VaxiRab), in Indian Cohort. Milestones (quarterly journal of DMER, Mumbai), Vol.2, No.4, October 2003, pg.170-176.

Followers (4)

Following (1)

Professional experience

Clinical Research Manager

Indus Biotech Private Limited

April 2008 - Present

Education

M.Sc.

Haffkine Institute For Training, Research and Testing, Mumbai University

March 2002 - February 2005(3 years)

M.Sc.

Haffkine Institute for Training Research and Testing, Mumbai, Mumbai University

March 2002 - February 2005(3 years)