Pharmacology Clinical Research Delhi : Elixir Web Solution

[mskavi]

A Reputed Healthcare Client of Elixir Web Solutions
http://www.elixir-consulting.com

Keywords: Clinical research, clinical trials, regulatory, protocols, mbbs, medicine pharmacology, phaseI phaseIV, hospital research, Head, Business Development

Designation: Director Clinical Research-An Upcoming Super Speciality Hospital
Experience: 12 - 22 Years
Location: Delhi/NCR
Education: UG - MBBS - Medicine
PG - M.S/M.D - Other
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 29 Aug 2008

Job Description
# To manage, direct, coordinate a variety of complex & independent activities involved in planning, supervising & conducting multiple clinical research studies, projects & also manage the entire operations of the clinical research
# Plans, implements & monitors all activities required to conduct & monitor complex clinical trails & ensure that good clinical practices are followed.
# Oversees all aspect of clinical trials management for Phase I to Phase IV clinical trials
# Establishes and implements guidelines for the collection of clinical data and/or administration of clinical trials, coordinates the ongoing analysis and modification of protocols as appropriate.
# Manages complete regulatory authorities applications & approvals for conducting clinical research.
# Manages and coordinates assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol (s).
# Provides medical guidance and leadership in the design, implementation, monitoring and interpretation of clinical trials.
# Monitors & directs clinical trials through out its duration.
# Supervises design & writing of protocols for clinical trials/ case reports form & informed consent forms for clinical trials.
# Reviews reports forms on time & submits to the data management groups.
# Ensures all research activities comply with company policies & regulatory systems.
# Coordinates & establishes clinical trials schedules, task assignments & allocation of manpower & equipment to ensure conformance with specified objectives.
# Serves as primary medical reviewer for clinical safety and efficacy data
# Responsible for the development, management & tracking of the clinical research budget
# Participates in the hiring, on boarding & training of the new staff

Desired Candidate Profile
# Qualifications: MD Pharmacology /M.D Medicine + Degree/Diploma in Clinical Research
# More than 15 years + Extensive Knowledge and understanding of management of clinical research operation starting from phase I to IV clinical trials & developing clinical research systems, protocols and processes in health services,
# Would be heading a large team of about 35-40 people.
# Reporting to CMD
# Location: Gurgaon.

Company Profile
Elixir Web Solutions, a leading Recruitment Process Outsourcing firm,
seamlessly integrates with corporate recruitment services model by providing on-site consulting, manpower planning, talent search, staffing, candidate assessments, HR outsourcing and software development as high cost effective solutions to the clients. Elixir has the flexibility to meet different needs of Recruitment, HR Outsourcing and Staffing services across Industries viz.ITES, Telecom, IT, Media, Infrastructure, Healthcare, B.F.S.I.(Banking, Financial Services and Insurance ), Research, Automobiles & Logistics, Consumer Goods and Life sciences. With strong presence in Global markets through shared service operations, Elixir clientele spans high profile early stage to large Fortune 500 companies.

ABOUT CLIENT:
An upcoming Super Speciality Hospital with a vision to bring in researched medicine in India.

Read A Reputed Healthcare Client of Elixir Web Solutions Blog

Executive Name: Megha Khanna-Senior Consultant

Address:
G-31
Kalkaji
New Delhi,Delhi,INDIA 110019

Email Address: meghak@e-lixirweb.com

Telephone: 91-011-41602695

Reference ID:
CLINICAL/ELX/2695

[Guest-IJT]

Career Objective
To obtain a suitable position in pursuance of promising career where Hard work and sincerity recognized and appreciated.
Name : Miss. Sheetal Prakash Sawant.
Areas of Interest :
Industry expected :
Contact No :
Email address : Regulatory Affairs(REGULATED OR NON REGULATED MARKET)
RA/Pharmaceutical/Biopharm/CRO/Food/Medical Devices/
Diagnostic/Biology/Biotechnology/Cosmetics/Veterinary product/
Cosmetics/pharmaceutical consultancy.

Sheetal.rocks90 AT gmail.com
Experience Fresher
Educational Qualifications
- Advanced Post Graduation Diploma in Drug Regulatory Affairs with 6 months internship in Perfect Pharma Consultant Pvt Ltd.
- Basic Diploma in Clinical Management & Regulatory Affairs
Haffkine Institute for Training Research & Testing.
Passed in 2010.
Knowledge Having :
- Training in ICH-GCP Guidelines of safety, QUALITY, Efficacy and Multi-disciplinary with respect to Tripartite Region and Other Asian Countries.
- Having knowledge of drug and cosmetic act, Y schedule, FDA, EMEA.
- Clinical Research Phases.
- International Regulatory Affairs for WHO, UKMHRA, USFDA, TGA.
- Project on Committee for Proprietary Medicinal Product (CPMP) dossiers for marketing authorization of nisoldipine tablet
- Bsc. Biotechnology :
Mumbai University : Mumbai college of Arts, Commerce and Sci, at Wadala.
Passed in 2010.
Projects :
- Spoilage of Home-made Chatni sample : Characteristics of organisms involved in spoilage of homemade Chatni sample were studied.
- Diet plan for a High Blood pressure patient : Nutrition and Diet plan for a High Blood pressure patient was prepared.
- HSC passed in 2006 from S.R.P. junior college, Mumbai University with 55%.
- SSC passed in 2004 from kumud vidya mandir, Mumbai University with 65%.
Workshop Attended :
- Attended and Participated 13th IDMA conference, 2010 held at Mumbai, Maharashtra.
- Attended workshop on DRUG REGULATORY AFFAIRS-QC/QA on 27thSEPT. 2009, organized by Asian institute of health sciences, Mumbai.
- Attended workshop on ICH GCP AND PHARMACOVIGILANCE on 4thOCT. 2009, organized by Asian institute of health sciences, Mumbai.
- Attended workshop CDM AND MEDICAL WRITING on 11thOCT. 2009, organized by Asian institute of health sciences, Mumbai.
- Summer Internship :
Organization : Milan Laboratories India Pvt Ltd, Kamothe, Panvel, Mumbai.
Period : One and Half Months.
Subject : To Understand Regulatory Affairs Profession and work on it.
Synopsis
- Review the documents used in QA/QC/Regulatory Affairs Viz. BMR, BPR, STP, ATP, SOP, APQR.PVR, MVP, Product Recall Protocol and Stability Protocol.
- Regulatory Affairs Documents : Review of DMF, MFR and Assisted in Preparation of CTD format Dossier.
Project guide : Mrs.Sharvari Deshpande, Quality Operation Head.
Technical Qualifications
- MSCIT in Computers from Govt. Of India.
- Internet operation.
Extra Curricular Activity :
- Participated in blood donation camp during Bsc. Biotech.
- Attended various drawing and painting computations during school and college days.
- Participated in various cultural events during bsc.biotech.
Personal Details
Language Skills :
English : Read: Write: Speak:
Marathi : Read: Write: Speak:
Hindi : Read: Write: Speak: