プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Dipti S.に依頼

Canada

ACRP certified clinical research professional with expertise in clinical operations, site management, project management

プロフィール概要

More than 16 years of extensive clinical research experience with expertise in following areas: Clinical Operations - Experienced in conducting site visits not limited to site qualification, site initiation, site monitoring: site close out. Review monitoring trip reports and provide appropriate guidance to CRAs, LCRAs, CTLs & CTAs. Performed quality assessment visits to ensure that the clinical study is performed as per the study protocol, standard operating procedures and applicable regulatory guidelines. Prepared and attended client meetings in areas including bid defence, kick off meetings, recruitment materials development, investigator meeting, and other client meetings (as required). Handled varied therapeutic areas: Stem Cell, Oncology, Neurology, Cardiology, Endocrinology, Burns, Dermatology & Ophthalmology in different phases from Phase I to IV and also extensive experience in medical devices studies. Maintained high retention rate of project team members within the countries in my purview. Country Operations - Experienced in handling operational aspects / country requirements / regulations of Singapore, Thailand, Malaysia, Philippines, Australia, Taiwan & South Korea countries. Also capable of handling remote team within APAC region. Hands on experience in preparing annual budget preparation. Project Management - Expertise in handling global projects and leading the study within APAC region. Well versed with Work Order, Budget and various project management tools. Ensured timely deliverables by meeting the project milestones. Feasibility - Can handle pre-feasibility enquiries coming through proposal team. Review RFP material (protocol and related documents), appraise new and current business opportunities to include proposal planning and perform recruitment strategy development in conjunction with global project managers and country operation managers. Can conduct multi-country feasibilities - Singapore, Malaysia, Thailand, Australia, Taiwan, South Korea, Philippines, Japan & India. Interpret and translate feasibility data for proposal group and key clinical team members. Write supportive documentation to serve as basis for proposal assertions. Tracked Feasibility Questionnaires through Survey portals (including paper questionnaires) and responsible for and maintenance of database. Analyzed and worked continuously to improve predictive performance metrics in support of activities focused on both business development and operations. Strong experience in performing site level feasibilities. Have built up strong network and rapport with Investigators and Sites. Regulatory Affairs - Maintain good working relationships with local regulatory authorities and ethics committees. Build and maintain strong working relationships between local staff, local team and functional stakeholders within and outside of the country. Training - Devised training modules on regulatory training framework for Singapore, Malaysia & Thailand. Experienced in imparting training both face-to-face and web-based.

専門分野

• ★ Clinical Trials
• ★ Dermatology
• ★ White Papers
• ☆ IRB Applications
• ☆ Patient Recruitment
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Regulatory Affairs
• ☆ Technical & Scientific Writing
• ☆ Course Content Writing
• ☆ Project Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, General Proofreading & Editing

Research Scientific and Technical Research

Consulting Healthcare Consulting

職務経験

Senior PM

Dermatology CRO

1月 2022 - 現在

Clinical Program Manager

Klinera

9月 2020 - 1月 2022

Senior Manager

Chiltern International Ltd

1月 2016 - 11月 2018

Manager, Clinical Operations

Chiltern International Ltd

2月 2005 - 12月 2016

Senior CRA

Reliance Clinical Research Services

11月 2003 - 2月 2005

CRA

SIRO Clinpharm

6月 2002 - 11月 2003

学歴

Master of Science - Psychotherapy & Counselling

The Global Open University of Nagaland

6月 2007 - 6月 2010

PhD - Applied Biology (Pharmacology)

Seth GS Medical College and KEM Hospital

10月 1997 - 6月 2002

MSc (Biochemistry)

Seth GS Medical College and KEM Hospital

6月 1995 - 6月 1997

BSc - Chemistry (Sathaye College)

University of Mumbai

7月 1992 - 5月 1995

認定資格

• Accreditation Council for Medical Affairs

  ACMA

  2月 2020 - 12月 2022

出版物

BOOK

(2012). Phytoceutics and Nutraceutics - Enriching Modern Therapy: Modern research in amalgamation with traditional concepts to explore the future of therapeutics in management of Lipids. LAMBERT.

(2010). Clinical Trial Monitoring - A Professional Handbook. ICFAI University.

BOOK CHAPTER

(2008). Advances in Biopharmaceutical Technology in India. BioPlan Associates Inc.