Clinical Trial Team Essay

Submitted By lifesmaster
Words: 1162
Pages: 5
Open Document
*******************
BSc. M.B.B.S., MBA
***, ****** Road, R******, RH* ***
E-mail: ******.********@gmail.com
-----------------------------------------------------------------------------------------------------------------
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
Show More

Related Documents: Clinical Trial Team Essay

Acct 2025 Assignment 1

Question #1: With external forces like an aging workforce, technology, lack of investment in education and the drug development industry notoriously slow to adapt, describe your vision of what the clinical trials industry will look like in 2025. The clinical research industry has a tendency to be slow to adopt new technology. It doesn’t seem like that long ago that case report form data was entered on paper 3-part NCR forms. Additionally, the FDA Guidance for Risk Based Monitoring was introduced…

Words 860 - Pages 4

Cho Dominican Research Center Case

assigned tasks to team members without any input from team members in certain situations. Each clinical research trial conducted in CHO Dominican Research Center is different from another. For this reason, and also because each RN-research coordinator has different specialties in the healthcare field, Deborah would assign the clinical research trial projects as she saw fit. A good example of this decision-making processes would be assigning the gynecologic oncology clinical research trial to a research…

Words 862 - Pages 4

Case Study: Ethical Issues Surrounding Emergency Preservationcitation

Ethical issues surrounding Emergency Preservation and Resuscitation – a case study Introduction Emergency Preservation and Resuscitation – or less elegantly, “suspended animation” – is a form of induced hypothermia that could potentially be used in clinical trauma settings to preserve life.1 The phrase “suspended animation” conjures visualizations of astronauts traveling through deep space in an unconscious, hypothermia-induced coma. The idea, however, has been discussed since the 1940’s, thoughtfully…

Words 535 - Pages 3

Breast Cancer Vaccine

provide my own views on different opinions and progresses of this new breakthrough. Mayo Clinic, one of the leading medical practices and medical research groups in the world, has a team of researchers that have been studying the science behind the new breast cancer vaccine. One of the leading researchers on this team and co-senior author on the study, Dr. Sandra Gendler, has been studying a certain molecule that is the target of the vaccine for over 25 years. This molecule, called MUC1, is a naturally…

Words 1972 - Pages 8

Intermountain: Health Care and Dr. James Essay

Situation Intermountain Healthcare was identified as a premier healthcare model in the U.S. for being able to offer high-quality care at cost below average, Through changes in infrastructure, clinical care management, protocol development, clinical integration and integration of management structure; Intermountain Healthcare has been able to lead the way is reduction of per capita health care spending in Utah. Leading the way in implementing this success was Dr. Brent…

Words 789 - Pages 4

kunal 1 Essay

preserve and extend access to Science News. http://www.jstor.org This content downloaded from 14.139.246.28 on Tue, 2 Sep 2014 02:41:23 AM All use subject to JSTOR Terms and Conditions form placebos only among extremely depressed individuals, says a team led by psychologist Irving Kirsch of the Univer sity of Hull, England. In these cases, rel atively weak placebo responses, rather than any heightened reactions to antide pressants, explain the medications' supe riority, the researchers hold. "There…

Words 1918 - Pages 8

Helapharm's Signs Of A Successful Obesity Treatment

recently discovered a new peptide that shows signs of a viable anti-obesity treatment. Helapharm has enough funding to get them through the next six months, but will not have enough money to fund the majority of the project. The pre-clinical development phase, clinical validation phase, and drug launch phase are three major phases that need additional funds for the successful launch of this novel drug. Helapharm has created this project plan outlining key milestones, timeline, costs, and financial…

Words 3290 - Pages 14

Mayo: Jury and Plaintiff Essay

BLAW 104-EV 2013 SPRING MOCK TRIAL ASSIGNMENT Written Pre-Trial Assignment (50 points) This will be completed by all students. You are to complete a written pre-trial document. It is to be typed. It shall be submitted on the first evening of the trial, April 15, 2013. Retain a copy for your use during the trial. Your paper should be between 4-8 pages in length. It should include the following: A. VOIR DIRE 1. Describe what strategy the Plaintiffs should employ…

Words 1383 - Pages 6

Orthoses In Physical Therapy Essay

use of a device that will assist the patient with breathing, especially patients that have breathing problems arise at night. While the patient is losing the ability to ambulate the physical therapy team will first provide adaptive equipment such as walker or crutches to keep the patient walking. If these do not work anymore the patient will be instructed with the use of a wheelchair. They will also be taught proper posture techniques to prevent the formation of scoliosis that often accompanies the…

Words 1761 - Pages 8

Pediatric Bone Marrow Chemplant: A Case Study

Assessment In the in-patient pediatric bone marrow transplant (BMT) unit, many patients are on clinical trials that include the use of chemotherapy. “The administration of chemotherapy to children with cancer is a high-risk process that must be performed in a safe and consistent manner with high reliability” (Looper, Winchester, Robinson, Price, Langley, Martin, Jones, Holloway, Rosenberg, & Flake, 2016, p.165). There are many components of the chemotherapy process, including prescribing, distribution…

Words 1666 - Pages 7