www.indegene.com Lifesystems Pvt Ltd Bangalore : Clinical Trial Analyst

[Admin]

indegene.com

Designation : Clinical Trial Analyst
Experience : 0 to 2 years
Position Type : Full Time
Functional Area : Scientific Content
Education : M.Pharm, MBBS, B.D.S
Work Location : Bangalore

Job Description :
1. Review of various clinical trial protocols and source documents.
2. Clinical trial data analysis, tagging and updating the database.
3. Advise data management staff on trial parameters, database designs, and validation of critical data.
4. Reports progress and changes in clinical trials.
5. Statistical analysis and competitive analysis of trial results.

Desired Profile :
1. Should have a qualified MBBS, BDS, M Pharm, B Pharm Degree.
2. A strong educational background in clinical research.
3. Computer skills including use of Microsoft word, excel and power point.
4. In depth therapeutic and clinical research expertise as well as knowledge of GCP/ICH and applicable regulatory
guidelines.

Soft Skills :
1. Client focus
2. Result orientation
3. Communicating with Impact
4. Team player
5. Process oriented

www.indegene.com/careers/openings.aspx

Indegene Lifesystems Pvt. Ltd.
C-19, 4th Floor
Everest Building
J. Dadaji Marg, Tardeo
Mumbai – 400 034
Tel : +91-22-40794079
+91-22-40794080

Indegene Lifesystems Pvt. Ltd.
Pine Valley, 4th Floor, Embassy Golf Links Business Park,
Off Intermediate Ring Road,
Bengaluru 560 071
Tel : +91-80-40787777
+91-80-3292 8845/46
Fax : +91-80-41267704

[bhogeshachari]

hai sir iam bhogeswarachari,m.pharm(pharmacology),iam intrested in clinical trails.
iam complted project trining in vimtalabs(cherlapally),hyderabad.
in my project training iam expose to protocol preparation,documentation,calculation of pharmacokinetic parameters,data handling,bioanalytical(proceess validation,insrumentation),
biostats exra...............
iam also completed sas(base sas,sql,macros,sasstats,sasgraphs,ods extraaaa)

[Guest]

PRAJAPATI VIKENKUMAR AMRUTLAL
M.Pharm. (Clinical Pharmacy)
E.MAIL : vikenprajapati AT gmail.com
MOB : +919099766377, +919824529895
10, Shreyas Park Society
Near Prerana Tirth Jain Derasar
Behind ISRO, Ramdevnagar, Satelite
Ahmedabad-380015.Gujarat, India
AREA OF INTEREST
- Clinical Research Associate.
- Medical Writing.
- Clinical Trail Assitant.
- Clinical Data Management.
- Bioavailability-Bioequivalence study.
- Pharmacovigilance.
- Regulatory Affairs
- Clinical QA.
ACADEMIC CREDENTIALS :
Course Subject College/School
University/Board
Year Result

M.PHARMA Clinical
Pharmacy A.R. College of Pharmacy, V.V.Nagar.Gujarat.
S.P. University,V.V.Nagar ,Gujarat 2010,60 %
B.PHARMA Pharmacy Shree Sarvajanik Pharmacy College, Mehsana, Gujarat. H.N.G.University,Patan. Gujarat. 2008 ,61 %

PROFESSIONAL PROFILE
From June-2010 to till date employed in Max-Neeman International (CRO), New Delhi as a Clinical Research Co-ordinator (CRC) at Ahmedabad, Gujarat
JOB PROFILE
Responsibility under in current organisation handling of Phase 4 trail of diabetes medication at clinical sites across Gujarat.
- Working as a CRA and Handling 25 trail sites for clinical trail in Gujarat.
- Site Initiation visit (SIV)
- Intermediate Monitoring Visit(IMV)
- Site close-out visit.
- Monitoring patient enrollement status in each site across Gujarat.
- Original CRF (case record form) fill up at each site from source document fill up by Principal Investigator.
- Visiting once per month each site for collection of data and monitoring adverse event occurring each site.
- Telephonic contact with principal investigator, marketing executive and business manager of Sponser Company.
- Handling Telecon with sponser, Investigator and seniour CRA of Sponsor Company.

Working Experience/Project Training(1 year)

Industry / Institute Time Period Area of Working
Nucare Laboratory,Mehsana-384002 3 months Production of Tablet and capsules
Zydus Research Centre ,Moraiya, Ahmedabad 5 months
(Aug-2009 To Dec-2009) Bio-analytical
(Project Trainee)
Institute of kidney Disease and Research Centre, Civil hospital campus, Ahmedabad 4 months
(Jan-2010 To April-2010) Clinical research
(Project Trainee)

COMPUTER LITERACY
- Working knowledge of MS-Office (Excel, Word, Power point)
- Conversant with e-commerce tools such as E-mail and Internet.

PERSONAL PROFILE

Name : Viken Kumar A. Prajapati
Father’s Name : Amrutlal J. Prajapati
Date of Birth : 25th Jan, 1987
Sex : Male
Languages Known : Gujarati, Hindi and English
Maritial Status : Unmarried
Nationality : Indian
Permanent Address : Prajapati Viken kumar Amrutlal
15, New Karkun Chal
Opp-Mahatma Gandhi Baug
Visanagar Road, Mehsana-384001.
Gujarat.



REFERENCES :
1) Dr. Pankaj R. Shah
HOD & Professor. Nephrology and Hypertension,
Institute of kidney disease & research centre,Civil hospital campus,
Ahmedabad,Gujarat.
Mob.+91-9998810145
2) Dr.(Mrs) Varsha J. Galani.
Aassitant Professor,
Department of Pharmacology,
A.R.College of Pharmacy,V.V.Nagar,Anand,Gujarat.
Mob : +91-9429161203.


DECLARATION :
I hereby solemnly declare that the above furnished particulars are true to the best of my Knowledge and belief. On the event of my selection to job, I shall endeavor my best the Maximum benefit of the institute/ company.
Yours Faithfully
viken prajapati

[Thaila R]

R.THAILA.
E-Mail :
thaila_ram AT yahoo.co.in .
thailucute1108 AT gmail.com
CURRICULAM VITAE
OBJECTIVE :
- Seeking a position to utilize my skills and abilities and to do job in a reputed concern.
ACADEMIC RECORD :
Post Graduation : Master of Pharmacy (M.Pharmacy)
- 2009-2011 : K.M College of Pharmacy, Madurai.
- Discipline : Department of Pharmacology.
- University : Dr. M.G.R Medical University, Chennai.
- Division : First Class (78%)
Under Graduatation : Bachelor of Pharmacy (B.Pharmacy)
- 2004-2008 : R.V.S College of Pharmaceutical sciences, Coimbatore.
- Discipline : Pharmacy
- University : Dr. M.G.R Medical University, Chennai.
- Division : First Class (75%)
HSC
- 2003 March : Amala Girls Higher Secondary School, Musiri
- Board : State
- Division : First Class (80.5%)
SSLC
- 2001 March : Amala Girls Higher Secondary School, Musiri
- Board : State
- Division : First Class (91.8%)
ACADEMIC PROJECT PROFILE :
U.G. Project :
Formulation Development and In-Vitro Evaluation of Ibuprofen for Targeting to Colon.
PROJECT DESCRIPTION :
The increasing awareness of targeting the drug to specific site triggered us to develop. Formulate and to evaluate the matrix tablet of Ibuprofen for targeting drug to colon
P.G.Project :
Effect of Hydroalcoholic Extract of Clitoria ternatea (L.) against Dimethylnitrosamine induced liver cirrhosis in Rat.
PROJECT DESCRIPTION :
Aims to give an overview on the recent development of herbal medicine in prevention in treatment of liver cirrhosis and covers the possible mechanism of action of clitoria ternatea in treatment of liver cirrhosis.

[lavigupta]

Dr Lovi Gupta
Email : lavigupta11 AT gmail.com , gupta.lavi AT yahoo.co.in

To obtain a position for health maintenance organization that will enable me purposefully utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.
________________________________________
Professional Summation
- 2 years of clinical research experience in Scientific Writing, Clinical Trial Monitoring and Subject Selection.
- One year additional clinical experience.
- A team-spirited professional with clear focus on priorities and deliverables.
- Scientific writing (Protocol, Investigator Brochure, Case Report Form, Clinical Study Report, Informed Consent Form, Common Technical Document etc.) as per ICH GCP guidelines.
- Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements
- Assist in managing clinical trial projects, ensuring on-time, on-budget performance
- Investigator Sites Monitoring (pre-study, initiation, routine, and close-out visits) for GCP compliance
- Investigator recruitment and study budgets negotiation
- BA/BE Studies
- Medical Coding of the diseases and diagnostic procedures through ICD 9
- Excellent computer proficiency and expertise in searching information through web
________________________________________Strengths
- Well-versed with clinical as well as research skills
- Able to work under optimal supervision
- Good communication and comprehension skills
- Quality documentation and accounting skills
- Excellent analytical, planning, organizational and interpersonal skills.
________________________________________Professional Scan
Aug 2009 - Mar 2011 Ozone Pharmaceutical Ltd, New Delhi and Guragaon
Sr. Executive Clinical research
Responsibilities :
- Scientific writing
- Assist in managing clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
- Investigator Sites Monitoring (pre-study, initiation, routine, and close-out visits) for GCP compliance according to Organization SOPs and/or client guidelines
- Recruit investigators and negotiate study budgets with investigators
- Coordinate and present at Investigators’ Meetings
- Resolve issues, questions, and requests for additional study supplies
- Review and approve monitoring trip reports
- Review and verify completed CRFs and clinical data in-house
- Resolve queries of CRF data with study site personnel
- Review Tables and Listings generated from study data

May 2009 – Jul 2009 The Himalaya Drug Company, Bangalore
Intern Researcher
Responsibilities :
- Medical writing
- Subject selection
- Site monitoring
- Dossier preparation and Literature Search
Feb 2007 - Jul 2007 Singhal Diabetic Clinic, Haridwar
Medical officer
Responsibilities :
- History recording, Physical and Systemic examination, Counselling and Diagnosis of Diabetic Patients and Diabetic complication scanning

Nov 2006 - Feb 2007 Rishikul State Ayurvedic Hospital, Haridwar
House officer
Responsibilities :
- History recording, Physical and Systemic examination, Diagnosis and Prescription writing
Nov 2006 - Feb 2007 Madhumeha Trust, Haridwar
Trainee Research
Responsibilities :
- Subject selection for Study of Oral Hypoglycaemic Herbal Drug for Type 1 Diabetes for Its Better Control with Nominal Side-Effects and Study analysis
________________________________________
Educational Credentials
2009 : MScCRRA (Master of Clinical research & Regulatory Affairs ) from Sikkim Manipal University, Grade ‘A’
2005 : BAMS (Bachelor of Ayurvedic Medicine & Surgery) from H. N. B Garwal University, Srinagar, 67%
Computing Skills
Operating Systems : Windows-2007/2000/XP, Windows Server 2003
Office Applications : Microsoft PowerPoint, Excel, Word.
________________________________________
Trainings Undertaken
- Three months training on Bio-analytical Techniques in the Department of Occular Pharmacology (Dr R. P. Center) AIIMS, New Delhi (Jun 2010 - Sep 2010)
Activities done : Separation of active constituents of Withania somnifera (50% methanolic extract) through HPLC,
Literature search for Hypoglycemic properties of Morus alba Leaves.
- Internship (Oct 2005 - Oct 2006)
o District Hospital- Har Milap Govt. Hospital, Haridwar, Uttarakhand (6 months).
o State Ayurvedic Hospital, Roorke, Uttarakhand (3 months).
o Rishikul State Ayurvedic Hospital, Haridwar, Uttarakhand (3 months).
________________________________________Conferences, Workshops, Smposium Attended & Presentations Made
- 4th World Ayurveda Congress & Arogya Expo organized by Department of AYUSH, GOI, Government of Karnataka and Vijana Bharti in Bangalore on 9th-13th Dec 2010.
- “2nd Hands-On-Workshop On “Bio-Analytical Techniques In Pk Studies – From Method Development To Data Interpretation” organized by Department of Ocular Pharmacology & Pharmacy, Dr R. P. Center for Ophthalmic Sciences, AIIMS in New Delhi on 4th – 5th Feb 2010.
- National symposium on “Contemporary Technologies & Concepts Revolutionizing Drug Discovery Strategies” organized by Department of Ocular Pharmacology & Pharmacy, Dr R. P. Center for Ophthalmic Sciences, AIIMS in New Delhi on 3rd Feb 2010.
- International conference on "Herbal Medicine -Evaluation of Quality, Efficacy and Safety" held in Bangalore, 26th, 27th, 28th Feb 2009.
- International conference on Translational Pharmacology & 41st annual conference of Indian Pharmacological Society-AIIMS, New Delhi on 18th, 19th, 20th Dec 2008
- Pre-conference workshop on the topic of Getting Started in Research and Scientific Communication- International conference on Translational Pharmacology & 41st annual conference of Indian Pharmacological Society-AIIMS New Delhi on 16th and 17th Dec 2008.
- National Conference on ‘Health for All through Ayurveda’ organized by Department of Ayurvedic & Unani Services, Govt. of Uttarakhand on 8th and 9th Dec 2005
- Presentation on “Anti-obesity drugs” in Department of Occular Pharmacology, R P Center, AIIMS, New Delhi.
- Presentation on “Ethics in Clinical Trial” at Institute of Public Health & Hygiene, New Delhi.
________________________________________
Membership
Life-time Membership of Indian Society for Clinical Research (Registration Number : 407)
________________________________________
Career Achievements
- Acknowledged by Dr H. M. Chawla, PhD, IIT Delhi for evaluation of the products formulated through Serumoid Technology
- Among one of the top 10 students during final year of the B.A.M.S, honored for the position of House Officer, by Dr P. K. Bhardwaj M.S. (Ayu), CMS Rishikul State Ayurvedic Hospital, Haridwar.

[Guest]

ANJU JOSEPH
E-mail anju158 AT gmail.com
Dear Sir/Madam
Let me introduce myself as Anju joseph, a 24 year old B-Pharm graduate who is currently doing 2 year M.pharm in Pharmacology. My course is almost over & only submission of thesis is remaining. I was very methodical in my studies & I am good in analyzing data. I have a flair for research work. My interpersonal skills are very good making me an effective team player which will help me to get along with any research team while on a project.
Our society needs novel drugs at affordable prices. This can be achieved to a great extent by developing the novel drugs locally rather than sourcing them from outside. In this context I am ready to give my best to the discovery & development of novel drugs which will enhance our nation’s superiority in healthcare & can alleviate the pains of the general public at large. I firmly believe that this is my life’s call I need your help to fulfill the same.
I am attaching my resume along with this. Please give me an opportunity to present myself before you at your convenience.
Career objective :
To lead a team of researchers making wonderful drug discoveries against many of the dreaded disease which will alleviate the sufferings of my people & uphold my country’s name in the field of healthcare.
Education :
Post Graduation : M-pharm (undergoing second year), Shree Devi College of Pharmacy,
Mangalore
Graduation : Academy of Pharmaceutical sciences, Pariyaram, Kannur(marks-75.8%)
Plus 2 : Kendriya Vidyalaya, Kadavantara, Ernakulam(Marks -74.8%)
Xth : Kendriya Vidyalaya, Kadavantara, Ernakulam(Marks -80%)
Computer literate : (MS office) (MS word)
Work experience :
Worked as a trainee at Ranbaxy Laboratories limited, Goa for two months.
Seminars attended :
1. Participated in National level Seminar conducted by All Kerala Pharmacy Teachers Association at APSC Pariyaram on 19th July 2008
2. Attended 62nd Indian Pharmaceutical Congress held at Manipal university on 19&20th of December 2010.
Best assets :
Highly positive attitude & ability to work hard & long
Analytical mind set
Good interpersonal skills
Disciplined execution,Focus on implementation of plans &strategies
Result orientation. A mindset, which is outcome focused
Activities, honors & achievements :
- Research article published on ‘In vitro antioxidant activity of Mussaenda frondosa in International Journal of Pharm Tech Research vol-2 issued at 2010
- Project work carried out on Evaluation of antioxidant activity of Bauhinia tomentosa, which involves both in vivo and in vitro studies.
- Third prize in dance competition in the Inter University Pharma Festival in the year 2006.
- Member of National Service Scheme.
- Participated in work camp conducted by NSS on March 2009 and December 2009.
Skills
- Instruments used : UV spectrophotometer, Semi auto analyser, Organ bath, Physiograph, Centrifuge, Colorimeter, Rotarod, Langendroffs apparatus.
- Animals : Rat, mice, frog.
Special interests
- Research
- Reading
- Drawing