Clinical Trial Team Essay

Submitted By lifesmaster
Words: 1162
Pages: 5

BSc. M.B.B.S., MBA
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E-mail: ******.********
Personal Profile:

Through continuous learning, acquiring new knowledge and thereby applying learned skills, I always aim to deliver best at work and also zealously achieve fulfilment in personal life.

Professional Experience

Global Project Lead
Phase 1 & 2
August 2012 to date:

As a project lead I:

• Manage protocols and related documents in collaboration with the Clinical trial Team (CTT): lead the clinical trial protocol development process; contribute to the operational and scientific input given for the development of trial-related documents and. •

Lead and matrix manage the global multidisciplinary clinical trial team (CTT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: lead trial level interactions with internal line functions and external CROs e.g. those providing monitoring and site management services.

Provide assistance in the coordination of TM related submission documents.

• In collaboration with CRO management & CRAs, identify sites and manage study set-up including support for initiation meeting.

• Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility. •

Regularly update all trial information databases in order to manage accuracy of information

• Approve for all necessary vendor payments as per financial agreements.

• In collaboration with the CTT, lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and.

• Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.

• Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.

Sept. 2010 to 15/08/2012 Clinical Project Manager Prototype Bioforum As an active member of clinical trials team, I • Managed a ‘proof of concept’ study to evaluate safety and efficacy of a drug; • Coordinated key tasks like regulatory submission & approval, ethics submission through a CRO. Also got involved in site training and monitoring in person as well as through CRO. • Co-ordinated development of all trial documents like IB, protocol, CRF & dossier contents. • Provided input to the clinical development strategy of the products. • Built alternative scenarios and risk benefit analysis to make recommendations in line with clinical development strategies. • Kept trial team updated with therapeutic area knowledge and current practices and provided training where needed. • Effectively utilized my knowledge of regulatory guidelines. • Ensured adherence to timelines and budgets.
July 2007 to Jan.10 Scientific Advisor Sanofi Aventis Being active member of the medical affairs team for metabolism (diabetes) and cardiovascular, I;

• Responded to customer’s queries on the products providing in depth clinical data analysis. • Worked along cross functional medical teams to design and execute product development strategies. • Developed, reviewed presentations and materials to discuss products while adhering to ABPI guidelines. • Provided support to clinical dept. in global and local phase IV clinical trials design and management. • Actively contributed to marketing strategy meetings as a product expert. • Worked along regional