Cadila Pharmaceuticals Pvt Ltd Dholka Ahmedabad : Clinical Research Data Management & Biostatistics

[shivi_jpr]

Department : CRO
Position : AGM Data Management & Biostatistics
Education Qualification : Ph.d / Master in Statistics
Experience : 8-10 years
Location : Dholka- R&D Center
Send Your Resume : careers@cadilapharma.co.in

Position: AGM – Data Management & Biostatistics

Responsibility:
* Head of Data Management and Biostatistics process of CRO
* To review clinical trial protocols for both internal consistency and across studies / projects
* To review Case Report Form (CRF) drafts for content, layout, protocol adherence
and appropriate consistency with established standards.
* To oversee set-up of data storage and transfer utilities and their testing
co-ordinate with sponsor on development of data review procedures, including edit check specifications, ensuring consistency between studies where appropriate
co-ordinate with sponsor on development of Data Management Plans
* Responsible for the statistical input provided by the group to all major documents, including clinical development plans, protocols, clinical study reports, summaries of clinical safety and efficacy.
* Advises Biostatisticians on technical issues associated with the design, performance, and analysis of clinical trials, review and guide biostatisticians on statistical aspects of all FDA / other regulatory agencies interactions, including FDA / other regulatory meetings, responses to FDA / other regulatory questions, and Advisory Committee Meetings.
* Provides leadership to therapeutic area Biometrics management team.

Skill Required:
* Comprehensive understanding of theoretical and applied statistics, extensive experience in clinical trials, understanding of regulatory guidelines in a pharmaceutical research setting.
* BLA/NDA development and submission experience required.
* Ability to effectively collaborate, communicate, and influence throughout all levels of the organization, strong leadership abilities

Contacts:
CADILA CORPORATE CAMPUS
Sarkhej-Dholka Road,
Bhat, Ahmedabad-382 210, INDIA.

www.cadilapharma.com

# dholka - manufacturing plant
* Survey No. 1389, Trasad Road,
Dholka, Ahmedabad-387 810, INDIA.

[Guest]

Samina Munshi
Education :
Degree University/Board School/College Year of passing Percentage
B.Pharm Gujarat University KIRC, Kalol 2011 Awaited
D.Pharm Guajrat University S.S.P.C, Zundal 2008 67.00
H.S.C. Gujarat Board H.B. Kapadia 2006 69.60
S.S.C. Gujarat Board Amrit Jyoti 2004 80.14
Skills :
- Quick- learner
- Excellent communication
- Creative thinking
- Patience and good listening
- Adequate GMP Knowledge
- Computer literate
- Able to work as an independent and in team
- Punctual and Self-disciplined
- Consistency and Steadiness in work
- Strategic approach
Achievements :
- Trained in Karate (Tae-k-Wando), Yogasanas and Music
- Certificate from Brihad Gujarat Parishad for Primary Sanskrit learning
- Participated in the ‘Classmate Young Author Contest’ held in 2004
- Participated in a 2 day workshop on mind power
- Participated in an essay competition organised by B.V.Patel PERD(Pharmaceutical Education & Research Development) Ahmedabad
- Participated in ‘Pharmacy Youth Essay Contest-2009’ organised by IJPR
- Completed a One Day Comprehensive Programme on ‘Scope and Potential After Pharmacy’ organised by I.P.E.R., Pune
- Participated in a National level Poster Presentation competiton( Pharmafest ’10)
Training :
1 month Industrial Training at V.S hospital, Ahmedabad
3 month Industrial Training at Cadila Pharmaceuticals, Dholka

[Guest]

RESUME

Name : Sarvaiya Jatinkumar Jagdishbhai
E-mail : sarvaiyajatin AT yahoo.com
sarvaiya.jatin88777 AT gmail.com
STRENGTHS :

Always Positive Attitude.
I am interested in field of clinical research and development.
CERTIFICATION :
I, JATIN SARVAIYA, declare that the above information is true and correct to the best of my knowledge and nothing has been concealed or distorted.
JATIN SARVAIYA
OBJECTIVE :
To work in a professional organization that offers good opportunities to prove my abilities and thus serve in the best interest of the organization. A challenging but rewarding opportunity, wherein my educational qualifications, skills and experience can be best utilized to the optimum, for the development of the organization.
ACADEMIC QUALIFICATION :

I have completed M.Pharm from A.R.college of pharmacy (Clinical Pharmacy), Gujarat Technological University, 2011 (Result pending)
I have completed my B.Pharm from L.M.College of pharmacy, Gujarat University, 2008, secure 67%
I have completed H.S.C from N.M high school, Ahmedabad 2004, secure 84%
I have completed S.S.C from H.H patel high school, Ahmedabad 2002, secure 91%
WORK EXPERIENCE :
After completion of B.Pharm, I have more than 1 year of experience in Pharma industries.
Company : Zydus cadila
Designation : Production chemist
Duration : 9 months
Company : Marck Bio-Science Ltd.
Designation : Production chemist
Duration : 5 months
THESIS WORK (M.PHARM PROJECT) :
I have completed M.Pharm Dissertation work on “To study the changes of ECG pattern in ACS patients” at CIMS Hospital Ahmedabad, VIBGYOR-CRO, under the esteemed co-guidance of Dr.Parloop Bhatt(Chairman ,Ethics committee of VIBGYOR-CRO)and guidance of Prof. Dr.N.N.Shah, (Department of Pharmacy, A.R.College of pharmacy). During this period I have undergone the training of various steps in clinical trial such as patient handling, CRF and e CRF filling, resolving queries in e CRF, talking the patient’s ICF etc.
GUIDELINES KNOWLEDGE :
Well versed with the I.C.H – GCP Guidelines for the Clinical studies.
COMPUTER KNOWLEDGE :
MS Word, MS Excel, Power point

[Guest]

CURRICULUM VITAE
VAIDYA JANKI NAYANBHAI
jankivaidya15 AT gmail.com
OBJECTIVES : Challenging & rewarding upper level position in growth-oriented organization, which offers diverse job responsibility in CRO and Pharmaceuticals etc.
EDUCATION QUALIFICATIONS :
M.Sc in Biostatistics in 2010-2011 (Maharaja Sayajirao University)-Pursuing.
B.Sc in Chemistry (Subsidiary- Zoology, Botany) in 2007-2010 (Maharaja Sayajirao University)
H.S.C (GSEB) in 2007 (Bright Eng School) with First Class
S.S.C (GSEB) in 2005 (Bright Eng School) with Distinction

COMPUTER SKILLS :
- M.S. Office, Windows OS and familiar with Internet.
- Advance Excel 2007 with data analysis tool pack.
- Basics of SAS 9.1 (Enterprise guide and Base SAS).
- Basics of SPSS 19.

ACTIVITIES :
Statistical Analysis in Drug Development and Discovery for two in 2012 (Maharaja Sayajirao University of Baroda)
ICH-GCP training sponsored by ICMR for One in 2011 (Gujarat University Ahmedabad)
Program on Statistics and Six Sigma for One in 2011 (Maharaja Sayajirao University of Baroda)
INDUSTRIAL VISIT (2011) : SunPharma for 3 days at Selvassa (Gujarat).
PG SEMINARS :
- Design of Experiments (CRD, RBD)
- Clinical Trials and its Design
- Drug development in Clinical Research.
ON GOING PROJECT : “To analyze at what vision do patient get operated for Cataract Surgery and their Risk factors”.
SOFT SKILLS :
- Ability to get along, morality values like loyalty, commitment and integrity
- Team work ability
- Fast learner and Progressive
- Committed to maintain quality.
ACTIVITIES :
- Seminar on Scientoons by P.K.Srivastava (2012).
- Seminar attended on spectroscopy and LASER (2010)
- Botanical Project (2009)
- Project on National park (Wildlife) Vadodara (2009)
EXPERIENCE : Fresher
EXTRA CURRICULAR ACTIVITIES :
- Participated in various interschool activities, cultural activities (dance) and annual sports.
- Participated in 1stNationwide Biotechnology Olympiad in EduHealFoundation in school.
- Gujarat Vidyapith exam held at Ahmedabad in school.
- Sanskar Bodh exams held in school.
- Elementary drawing grade examination at State examination board in school.
- Participated in outdoor sports in badminton competition in collage.
- Event management of annual cultural programs in college.
- Indian classical music exam (3years), ‘Gandharva Mahavidyalaya’- music institution in cultural legacy.
- National Himalayan Trekking Expedition organized by youth hostel association of India (yhai) at sarkundi pass, kullu-manali himachal Pradesh during May 2011.
HOBBIES : Performing arts like singing, acting, dancing; travelling, sports, listening music & trekking.
LANGUAGES KNOWN : English, Hindi & Gujarati.
DECLARATION :
I solemnly declare that all the information furnished above is factually correct and true to the best of my knowledge and brief. I accept that the appointment given to me on this basis can be revoked and/or terminated at any time in future if any information is misstated or unstated.
J.N.Vaidya

[Guest]

RESUME

Objective :
To become a technically sophisticated and business savvy management professional with a pioneering career focus on the latest Information and involve myself in pharmacy field and maintaining of high caliber for a highly motivated pharmaceutical company.

Mansuri md.Faizan S. (Degree B.pharm)
Email : mdfaizan.mansuri AT gmail.com

Educational Qualification :
Exam Passed School / College University Institution Year of Passing :
S.P.I. S.S.C GSEB 2005 81.43%
H.S.C GSHSEB 2007 58.67%
B.pharm Gujarat Technical University 2012 CPI 8.0

Last four semesters combine C.P.I. Are 7.94 with 8th sem. Running.

Extra activity/Project :
Ø I was participated in poster presentation which is about plant tissue culture in pharmacognocy at H.N. Shukla pharmacy collage.
Ø I was participated in poster presentation which is about “role of cannabinoids receptor in Alzheimer’s disease” in pharmacology in pharmavision 2011 at maliba pharmacy collage.
Ø I have passed my B.pharm exams with CPI 8 out of 10 with over all distinction.
Ø I have participated in poster presentation of plant tissue culture at Rajkot in GUJKOST 2011.
Ø I have participated in poster presentation in cology on topic "role of cannabinoids receptor in Alzheimer’s disease" at PHARMA VISION 2011 at bardoli.
Ø I have attains one day seminar of "change to change" at siper.
Ø I have participated in drawing competition at NIRMAQUEST 2011 at Nirma University.

Area of Interest :
· Production
· Marketing
· QA
· QC
· R&D

References :
Ramde D. Nandaniya (Professor of siper institute)

Declaration :
I declare that the information given above is true to the best of my knowledge and belief.

Date : 24 may 2011
Place : Ahmadabad Faizan S. Mansuri

[Unregistered]

Janak Gangaram Gondaliya
Keshod

E-mail : gondaliyajanak415 AT gmail.com
A student of Biotechnology at ARIBAS College, V.v.nagar, who wants to serve the field for benefits of society & can work on its own initiative & also as a part of a team with an organized approach. During school and college days exhibited leadership skills by involving and motivating others for cultural and educational activities. Willing to maintain high quality standards & have burning desire to make carrier in the world of Biotechnology.

Date of Birth : 16thsep1991
Gender : Male
Marital Status : Unmarried
Religion : Hindu
Nationality : Indian
Languages Known : Gujarati, Hindi and English
Hobbies : Reading books, Music, getting online information
Addiction : None
Interest subjects : Molecular Biology, Bioinformatics, Immunology

Specialization : M.Sc. Biotechnology (General)

Exam Board/ University Passing year Result :
S.S.C. G.S.E.B., Gandhinagar March – 2006 77.00%
H.S.C. G.S.H.S.E.B., Gandhinagar March – 2008 56.00%
T.y B.sc Saurashtra university March – 2011 68.00%
M.sc sem1 S.P. University, V.V Nagar Nov.-2011 6.52 GPA
M.sc sem 2 S.P. University, V.V Nagar March – 2012 6.16GPA
M.Sc. sem. 3 S.P. University, V.V Nagar NOV.-2012 5.88 GPA

RECENT : Study in M.Sc. in Biotechnology (General) Semester 4 in ARIBAS college,
Finding the job in the field of biotech

[Unregistered]

PRATIBHA RAWAT
DATE OF BIRTH : 02-10-1989
E-MAIL : pratibharawat.ei.2035 AT gmail.com
Barabanki (U.P) ,225001

CAREER OBJECTIVE :
To seek a challenging and growth oriented profession wherein I can apply my skills to strengthen my working environment and to add to the competitive edge of the company

SCHOLASTIC RECORD :

Degree/University Institution Year Score :
Bachelor of Engineering
(Electronics and Instrumentation)
Gautam Buddha Technical University(UPTU) United College of Engineering & Research,Allahabad July 2008-June 2012 69.14(Aggregate of 8 semesters,
UPTU)
Class XII (U.P Board) Pioneer Montessori Inter College,Barabanki July 2006- june 2007 72.8%
Class X (U.P Board) Pioneer Montessori Inter College,Barabanki June 2004-june 2005 73.2%

SYNOPSIS :
A fresher with B.Tech Degree in Electronics and Instrumentation Engineering from Gautam Buddha Technical University(U.P.T.U), Lucknow. Posses knowledge of practical electronic circuit design and basic of C.

PROFILE :
- Basic knowledge of C.
- Analytical, good at problem solving and excellent in maintaining interpersonal relationship.
- Good verbal and written skills.

PROJECT :
Prototype Metrotrain using Microcontroller at89c51
In this project we try to give the same prototype of metro train. These trains are equipped with the CPU, which controls the train. The train is programmed for the specific path. Every station on the path is defined; stoppage timing of the train and distance between the two stations is predefined.

FIELDS OF INTEREST :
- Biomedical instrumentation
- Control system

ACADEMIC ACHIEVEMENTS :
Achievement
- Good student of school in High School & Intermediate.
- Scholarship holder for two years by cracking the Chatravratti Pratiyogita in class 9th.
- Always among the top 10 students of the class during schooling days.
Second position in Essay Competition at regional level.

EXTRA CURRICULAR ACTIVITIES :
Summer Training :
- Participated in ENIGMA’08 , an annual event in UCER.
- Participated in CATHARSIS ’09, the intra-college sports festival.
- Member of EI Society in UCER.
- Participated in SHIKHAR-2K11 in UCER.
- Participated in Technical Fest of UCER.
Four weeks training in “HINDUSTAN AERONAUTICS LIMITED,LUCKNOW”.

STRENGTHS :
- Determined to learn with practical approach.
- Good communication skills.
- Enthusiastic and can produce results under deadline constraints .

PERSONAL DETAIL :
Father's Name Lt.Arjun Dayal Rawat
Date of Birth 02-10-1989
Sex
Marital Status Single
Languages known English, Hindi.
Hobbies Playing Computer Games, solving Puzzels,Listening to music.

DECLARATION :
I hereby declare that all the information provided here is correct to the best of my knowledge and belief and I promise to abide all the norms laid down by your esteemed organization.
PRATIBHA RAWAT