www.allergan.com India Pvt Ltd Bangalore : Clinical Research Data Coordinator

[deepika]

Allergan India Pvt Ltd
allergan.com
http://www.allergan.com

ALLERGAN INC
Allergan Inc. a Fortune 700 (2007 Rank #644) company, with headquarters in Irvine, California, USA is an innovative, technology driven, global health care company that develops and commercializes products for the ophthalmic, neurological, dermatological and other specialty markets. Allergan markets products in over 101 countries worldwide through its global marketing and sales capabilities and delivers value to customers, satisfies unmet medical needs and improves patient's lives through its discovery-to-development research programs.

With global revenues of $3.9bn in 2007, Allergan has tremendous focus on R&D with an investment of $700mn which is roughly 19.5% of revenues (highest percentage among pharma industry). Allergan operates 33 commercial locations, 4 world-class Research and Development facilities and 3 state-of-the-art manufacturing plants. AGN has many new chemical entities in phase 3 clinical stages out of which 6 products are in the Glaucoma therapy area only.

Allergan is known for its operational efficiency and for this reason Allergan is rated by Forbes magazine (edition dated 20th December 2007) as the best managed company in the US in biotech/health business.

ALLERGAN Pharmaceutical Development Centre India Pvt. Ltd.
Allergan Clinical research unit based in Bangalore is a state-of-the-art facility which is a 100% subsidiary of Allergan Inc and operationally reports to Allergan Pharmaceutical Development Centre, UK. Allergan Clinical Research Unit does captive research for Allergan Inc. Clinical Data Management is a liaison group which supports the central team in Irvine responsible for all data management activities within the Asia Pacific Region.

Designation : Clinical Data Coordinator - Clinical Research

Job Description
1. Efficiently utilizes scanning software to accurately process CRF's used in product studies to be submitted to various governing agencies for approval. CRF acquisition and QC must allow timely and efficient Data Entry and Data review processing by other Clinical and Data Management personnel worldwide.
2. Organization and coordination of internal CRF reception activities supporting clinical trials in one or more therapeutic area. Responsibilities include trouble shooting of data collection issues with other Data management and Clinical personnel according to appropriate regulatory and company and departmental guidelines.
3. Training new external vendors and in-house temporary personnel on CRF processing as well as the efficient use if the CRF scanning system.
4. Responsible for supporting the documentation, testing, implementation, validation and utilization of systems and processes within the Clinical Data Management area.
5. Implements data management procedures compliant with Regulatory requirements. Ensures the consistent implementation of procedures, data standards and data coding dictionaries across assigned studies within therapeutic areas.
6. Knowledge of utilization of atleast one database system ( such as BBN/Clinical trial, Oracle, Informix, Ingress, Sybase, Access, dbase IV-V, Paradox, DBII).
7. Derail-orientation, excellent analytical, problem solving and computer skills.
8. Flexible, well oriented, and strong communication and inter-personal skills.
9. Excellent organizational, verbal, written and inter-personal skills.
10. Ability to work on a multi disciplinary team with multiple priorities.
11. Works well under pressure, with initiative to take on unfamiliar tasks.

Desired Profile : Good Communication Skill, Interpersonal Skill.
Experience : 2 - 4 Years
Location : Bangalore
Keywords : Clinical Data Coordinator , Clinical Research

Contact :
Allergan India Pvt Ltd
http://www.allergan.com

[Guest]

Curriculum Vitae


Bhavik R. Shah
19 / A, Aangan bldg.,
P & T Colony, Dombivali (E)
Ph no.:0251-2820221, 9322919125 Email Id: unobhavik@yahoo.com

Objective:
To seek a challenging career in pharma field. To work as a project manager in the clinical research field.

Educational Qualification:
1. M.Pharm (Pharmacology) from Vinayaka Missions College of pharmacy
2. Postgraduate diploma in Clinical Research from K.M.Kundnani College of Pharmacy, Mumbai
3. Bachelor of Pharmacy from Parshvanath College of Pharmacy, Thane, Mumbai University, Maharashtra

Academic Record:
Examination University Month & Year of Passing Marks obtained Class
M.Pharm Vinayaka missions May-2008 678/1000 1st

Personal Information
Name : BHAVIK R. SHAH
Date of Birth : 6TH Dec. 1983
Gender : Male
Marital Status : Single
Languages known : English, Hindi, Gujarathi, Marathi

Project Work:
1. A one month project work in Cipla pharmaceuticals.
2. A project on marketing management in 3rd year of pharmacy.


Work Experience:
1. A 8 monthly project on pharmacokinetic study of test drugs in a randomized parallel design trial in DMRI-CRO, Navi-muimbai from Mar-2008 to Dec-2008.
2. Worked in Torrent pharma as a medical representative from Mar-2006 to June-2007.
3. Worked in Franko-india pharma (Q.C) for 6 months from Aug-2005 to Feb-2006.


Extra Curricular Activities:
1. Ratan tata scholarship in 1st & 2nd year of graduation.
2. 2ND Prize in-group dance, drama competition in Rx festival.
3. Cultural head of college in final year.
Declaration:

I hereby declare that the information given above is correct to the best of my knowledge and belief.
Place:

Date: Signature:

[Guest]

Curriculum Vitae

Dr.Pallavi Dixit

My Career Objective:
I am looking for an opportunity in A Dental Hospital/Clinic or Organization(s) or as faculty in any renowned institute of dentistry for promoting Dental Health Education.
I consider myself creative and reactive, as well as flexible and energetic. Furthermore, with the qualities I have developed and strengthened during my Professional degree and clinical work experience, I can offer my meticulous skills to the patients attended by me.

My Ideal Company:
A Dental Hospital/Clinic or Organization(s) or as faculty in any renowned Institute of Dentistry

Education :
10+2 from St. Mary’s Inter College, Etawah (U.P.) {C.B.S.E board}
2003 to 2009 - Bachelor of Dental Surgery, Rama Dental College & Research Center, Kanpur, (U.P.) affiliated to Agra University.
Level Achieved: Bachelor Of Dental Surgery - passed B.D.S along with one-year rotatory internship on March 31st 2009 by securing an aggregate of more than 65% marks.
Recently gaining clinical experience since April 2009, under the able guidance of Dr.Dharmendra Singh (Dental Surgeon) running his own private practice here in Etawah since 10 years.
Also attending Health Camps organized under C.M.O., Etawah at various Primary Health Care Centers as an on call Doctor (Dentist), every month.

[Guest]

Rajalakshmi Puttaswamy rajalakshmi80 AT gmail.com
Objective :

To seek an exciting and challenging position to utilizing my knowledge, skills and experience in CRO Industry.
Professional Summary :
Environment : Oracle Clinical 4.5.1 and Electronic Data Capture
- Performing Query Management like Raising/Closing DM Queries
- Conducting basic data review
- Writing/ Resolving Data clarifications as directed by the Clinical Data Manager
- Performing User Acceptance Testing for both database and Edits specifications
- Performing Quality Control procedures on Study database
- Generating and sending Project Status report to the Client.
- Understand and comply with core Standard Operating Procedures and related SOP Forms
- Performing Quality control Procedures on Data Management Standard Operating Procedures and related SOP Forms, Created Flow Charts for DM SOP’s
- Understand, and comply with all applicable sections of Data Management Plan
- Performed Discrepancy Management like creating, sending and printing DCFs
- Performed CRF/DCF tracking
- Worked on Preparing Data Management Plan (DMP) documents (eg. Edit specification, CRF filling guidelines) etc.
- Lead the Projects & Performed Data entry as per Clinical Data Management Specifications
- Prepared DMP documents like Data Entry Guidelines/Data Tracking Guidelines
- Trained New employee’s on Process flow of Data Management.
- Understands and comply with ICH-GCP, core operating procedures and work instructions
- Performed Screen Testing for OC database which is live for production
- Created and Entered data for Clean and Dirty patients for testing purpose
- Performed CRF designing in Adobe Frame maker v7.2 and OpenClinica EDC software
Professional Experience :
- Currently working in Provenance Research India Pvt. Ltd., Bangalore, as a Clinical Data Coordinator from 2nd Aug 2010 to till date.
- Worked as a Clinical Data Associate with Reliance Clinical Research Services Pvt. Ltd., Bangalore, from 9th April 2007 to 29th Jul 2010.
- Worked as a Clinical Data Assistant with Quintiles Technologies Pvt. Ltd., Bangalore from 01st Sep 2005 to 3rd April 2007.
Educational Qualifications :
Completed Bsc from Bangalore University
Completed Professional Diploma in Clinical Research (PDCR) from Catalyst Clinical Research, Delhi

Technical Skills
Operating System WINDOWS 9X/2000/XP.
RDBMS ORACLE 9i. EDC
Packages MS-Office (MS-Excel, MS-Word, PowerPoint).
Delhi, Catalyst Clinical Research PDCR (Professional Diploma in Clinical Research)
Professional Experience PROVENANCE RESEARCH INDIA Pvt. Ltd. Bangalore.
RELIANCE CLINICAL RESEARCH SERVICES Pvt Ltd. Bangalore.
QUINTILES TECHNOLOGIES Pvt. Ltd.
Bangalore.
Project Exposure :
Project Experience
Therapeutic Indication Phase Description of Responsibilities and Tasks
Harmone-Refractory prostate cancer Phase II - Conduct basic data review.
- Write/Resolve
Data clarifications as directed by the Clinical Data Manager
- UAT of Database and edit specification
- Conduct basic quality control procedures on Study Database
chronic Hepatitis B Phase III
- Raised/ Resolved
Data clarifications as directed
by the Senior Clinical Data
Coordinator
- Conduct basic data review
- Performed Critical QC/Final QC
Cardiovascular and Cerebrovascular Diseases
Phase III
- Raised/ Resolved
Data clarifications as directed
by the Senior Clinical Data
Coordinator
- Prepared DMP documents
- Performed Critical QC/Final QC
Oncology Phase II - Lead the project and performed Data Entry (second pass)
- Prepared Data Entry Guidelines
- Tracking of missing pages and Header queries
Rabies Phase I - Lead the project and performed Data Entry (second pass)
- Tracking of missing pages and Header queries
Treatment of Cachexia Phase II - Performed Screen Testing
- Data Entry in Oracle Clinical 4.5.1
- Tracking of missing pages and Header queries
Chronic kidney disease with Anemia Pre-Marketing - Data Entry in Oracle Clinical 4.5.1
- Tracking of missing pages and Header queries
- Performed screen testing
Opioid Induced Bowel Dysfunction Phase I - Data Entry in Oracle Clinical 4.5.1
- Tracking of missing pages and Header queries
Comparative Therapeutic Biosimilarity Study Phase II - Data Entry in Oracle Clinical 4.5.1
- Tracking of missing pages and Header queries
Prevention of risperidone-induced weight gain in healthy male volunteers

Phase IIa - Data Entry in Oracle Clinical 4.5.1
- Tracking of missing pages and Header queries
- Performed screen testing
- Performed Critical and Final QC
- Performed Quality Review after IInd Pass entry
A randomized, balanced, open –label, single-dose, two-treatment, two sequence, two-period, crossover, pilot study
Bioavailability Study
- Single Data Entry in Oracle Clinical 4.5.1
- Performed screen testing
- Prepared Database Specifications
HIV-Associated Lipodystrophy Phase III - Data entry in Oracle Clinical 4.0.3
Hepatitis B Virus(HBV) Vaccine Phase III - Data Entry in Clintrial 4.3
Q-Lab - QINT-Invoice Tracking
- QNET-Providing Access to the Protocol Studies

Systems Experience/IT Skills
Clintrial 4.3 and 4.4
Oracle Clinical 4.0.3 and 4.5.1, Go CRF
Generating Crystal reports in OC
Adobe Framemaker v7.2
Adobe Actrobat v6.0
OpenClinica EDC Software
Medrio, PheedIT EDC Software
Training received
ICH-GCP
Company’s Standard Operating Procedures and Policies
Discrepancy Management
Oracle Clinica RDC training and OpenClinica EDC Software
Medrio, PheedIT EDC software
Data Entry training in Oracle and Clintrial
Quality Control
Personal effectiveness
Team building
Screen Testing
Oracle Clinical Overview
CRF Designing Using Adobe Frame Maker 7.2
Scholarships and Awards :
Received 2 Instant Awards in Quintiles Technologies for good quality data
Other Relevant Details
Languages :
English, Hindi, Kannada, Telugu and Tamil
Hobbies
Listening to music and playing carom
(RAJALAKSHMI PUTTASWAMY)

[Guest]

FARZANA BEGUM

Email : farujan10 AT gmail.com
Career Objectives : Look forward for an opportunity that would utilize my knowledge and skills, which could enable me and the organization to grow and prosper. In accordance with this goal, I would like to pursue a career pertaining to clinical Research.
Educational Qualification :
SI No subject Year University Percentage
1 PG diploma in clinical research 2011 Avigna Pursuing
2 MSc. Biochemistry 2007- 2009 Bangalore university 65%
3 BSc. Chem, botany, zoology 2005- 2007 Bangalore university 86.6%
Summary of Skills in Clinical Research
- Proficient knowledge and good understanding of Clinical Trial Process.
- Good knowledge of ICH-GCP guidelines, regulatory requirements, and other guidelines.
- Knowledge of roles and responsibilities of Monitor, Investigator, and Sponsor.
- Good knowledge of Protocol and Case Report Form Design, Informed Consent Process.
- Good understanding of Quality Assurance and Quality Control in Clinical Research
Work experience :
1. Worked in Chromous Biotech wet lab- 5months
DNA extraction & purification, DNA ladders, Chromatography, preparation of biosolutions, protein purification, PAGE, Native PAGE, immunological kits
2. Worked as a project assistant in a UGC project, Bangalore University. -8months
Antioxidant phytochemicals in conjugation with n-3 fatty acids : Their influence on release of inflammatory mediators of macrophages.
3. Currently working as a CRC in Kidwai Hospital
Accomplishments :
1. Honourse course in genetics – Dermatoglyphic (2005-2006)
2. Honourse course in medical transcription (2006-2007)
3. 1st place in ecofriendly model making
4. Attended workshop on Accelerating Research Discovery and Innovation.
.
I hereby declare that the particulars stated above are correct to the best of my knowledge.
Place : Yours faithfully,
Date : Farzana Begum

[Guest]

Shanker krishnamoorthy
E-mail : kshanker.krishna AT gmail.com

OBJECTIVE :
Aiming for Career Enhancements in Pharmaceutical and Clinical Research Field which Provides Challenging Assignment and Environment that Encourages Continuous Learning and Provides Exposure to New Ideas.
PROFESSIONAL EXPERIENCE :
CLINICAL RESEARCH EXPERIENCE - 4 YEARS 3 MONTH
Job Profile Duration Job Description Employer
Senior QA Associate Oct 2009 - till date Working on 2 interventional and 3 Observational studies Translational Medicine India Pvt Ltd
QA Associate Mar 2008 - Sep 2009 Worked in 4 Interventional studies, 5 Observational studies Translational Medicine India Pvt Ltd
Clinical Research Coordinator Mar 2007 – Feb 2008 Worked in 2 Oncology, 1 POC, 1 Observational studies Translational Medicine India Inc
Medical Representative Sep 2005 - May 2006 Sales and Marketing Glaxo Smith Kline Pvt. Ltd
EDUCATIONAL QUALIFICATION :
Qualification Board/University Year of Passing
MSc in Clinical Research (ICRI) affiliated with Cranfield University, UK Aug 2006 - Apr 2008
PGDPM (Post Graduate Diploma in Pharmaceutical Management) Institute of Clinical Research India (ICRI) Aug 2006 - Aug 2007
Bachelor in Pharmacy Dr. M.G.R. Medical University Aug 2001 - Aug 2005
Diploma in Pharmacy Dr. M.G.R. Medical University Apr 1998 - Apr 2000
ROLES AND RESPONSIBILITIES IN CLINICAL RESEARCH FIELD :
Experience in Clinical Data Management System :
- Conduct Data Base Audits, Data validation, Generation of DCFs.
- Generation of Audit report and communicating the issue/s to the concerned personnel.
- Reviewed of Data Base (Excel Data Base) for before Data entry.
- Assisting data management team in generation of internal Data Management related SOP/s.
- Review and Quality Control of Data Management related SOP/s.
- Trainings the team on relevant SOP/s.
- Trained in handling electronic-Case Report Form (e-CRF) Follow up with site staff during the internal QA monitoring visits to ensure the data from patient clinical notes has been transcribed into e-CRF in timely manner/based on study visits.
- Trained in Clinical Data Validation
- Trained in Clinical Data Entry
QA Monitor / QA Associate :
- Conduct internal QA visits to check compliance to GCP, study protocol and other regulatory requirements, Ensuring proper storage, dispensation and accountability for clinical trial supplies at study site.
- Generating QA visit report and communicating the observations with the study team.
- Conduct internal QA Audit visits like investigational site Audit, In-house Audit, Data base Audit, Trial Master File Audit for compliance of GCP.
- Generate the Audit report along with categorizing the findings within the given timelines.
- Coordinate action plan implementation and quality control from the observations made during the Quality Assessment visits.
- Participate in the strategic planning and implementation of Clinical Audit plan; manage Corrective And Preventive Action (CAPA) plans.
- Preparation, review and quality control of Standard Operating Procedures (SOPs).
- Assist the project managers with the preparation of regulatory submissions, follow-up for approvals.
- Review of essential document before regulatory submission and ethical submission
- Interface Project Management like preparations and conduct of feasibility visit (Site, Laboratory and Courier).
- Involved in designing of essential documents like protocol, Case Report Form, Informed Consent Document, Data Collection Form, Source Document and various logs with review.
- Provide team with a list of pending essential documents prior to site visits, to ensure that documentation is maintained as complete and accurate throughout the clinical trial.
- Provide support to the Project Team through documentation review, maintenance, and tracking.
- review of study files periodically for accuracy and completeness
- Study close out procedures involving CRF retrieval, archiving, and communications to Sponsor, IRB and DCGI, drug destruction
- Tracking & indexing site specific essential documents - creating site specific shadow files.
ICH GCP Training and Technical Induction :
- Conducting Technical Induction for New employees
- Provide training on GCP and other required clinical research topics to staffs, educating and evaluating their knowledge by conducting tests
- Organized the Investigator Meeting for Device study, Bio-similar study, Narcotic Drug Clinical Trial
- Participated in couple of Investigator Meetings.
Clinical Research Coordinator :
- Assisted in designing documents like ICD, CRFs other study logs (Like : Subject Screening Logs, CRF Inventory Log, CT scan Inventory Log, Drug Accountability Log, etc.,)
- Assisted in ICF administration process and Subject recruitment process
- CRF Annotation, CRF Checking & CRF Retrieval
- Assisting for Regulatory Submissions & Ethics Committee Submissions.
- Communication with the Institutional Review Board
- Maintenance and updation of Site Master File
- Data Query Generation, Drafting of Guidance Documents
- Serious Adverse Event – Reporting to Sponsor, IRB
- Involved in the process of archival of study documents after the study completion.
- Assisted in Drug Destruction process
- Data Entry Operator
- Learnt the process of data validation from Double-Data Entry
- Raised queries through Data Clarification Form and interfaced with appropriate person to bring them to resolution.
PROJECT WORKED AND WORKING ON :
INTERNAL AUDITS AND MONITORING :
- 14 Internal Audits (Site Audit, System Audit, Data Base Audit and In-house Audit)
- 33 QA Monitoring
INTERVENTIONAL TRIALS :
- 4 Oncology Trials : (Phase II and Phase III)
- 2 Ophthalmology Trials : (Phase I and Phase II)
- 2 Gastroenterology Trial : (Phase III)
- 1 Rheumatoid Arthritis : (Phase III)
NON- INTERVENTIONAL TRIALS :
- A Registry Study to Understand the Disease Characteristics in Rheumatoid Arthritis.
- A Pilot Study to Evaluate the Molecular Markers in Type 2 Diabetes Mellitus in Adults
- A Prospective Study to Determine the Incidence and Prevalence of Respiratory Syncitial Virus in Children below Tow Years of Age.
- Pilot Study to Correlate Molecular Markers in Rheumatoid Arthritis Subjects
- A pilot study to establish prevalence, standard of care, diagnostic criteria and outcomes of gastrointestinal diseases in a tertiary care hospital setting and correlate it with conventional and molecular markers
- A pilot study to correlate molecular markers in Ulcerative Colitis and Irritable Bowel Syndrome subjects.
OTHER FIELD EXPERIENCES :
- Worked as Pharmacy Counselor and Community Pharmacist in retail pharmacy shops from Nov 2002 – Feb 2005 and Sep 2006 – Feb 2008
- Worked as Pulse Polio Monitor for WHO project in Jan 2004
OTHER SKILLS :
- Knowledge in MS Office
- Good Team player with good communication skills, comfortable communicating one to one & addressing large audience

[Guest]

Email : jeetsahoo6 AT gmail.com
Jitendra Kumar Sahoo

Career Objective
Aspire to work in Clinical Research Organization and be an optimal solution provider for the industry by applying the knowledge and skill sets gained from academic and field experience. Committed to strive for continuous excellence and contribute substantially to incorporate exceptionally high degree of innovativeness towards the achievement of personal and organizational goals.

Selected Achievements

- Got training on Clinical Research specialization in Clinical Data Management, Oracle Clinical (OC), and Statistical Analysis Software (SAS).
- Successfully completed and passed the FDA Smart Inc Programme : “ Understanding FDA and the FDA Approval Process ” delivered by Dr. Joshua Sharlin, USA (Former USFDA Reviewer), ICRI, Bangalore, 2009.
- Achieved certificate for participating in a symposium on frontier areas in Genomics & Clinical Research at The Oxford Educational Institution, Bangalore, 2006.
Professional Experience
1) Research Associate – Medical Writer Mar. 2011 – Jun. 2011
MMSH Clinical Research Pvt. Ltd.
Responsibility :
- Reviewing of abstracts (Literature Review Process).
- QC of Clinical Study Reports.
- Updating time log in the data base on a daily basis.
- Attending soft skill training and discussing the process of abstract review in meetings.
2) QA Executive Apr. 2010 – Dec. 2010
Value Point Knowledge works Pvt. Ltd

Responsibility : Will be responsible for end document quality both from linguistic per se and as well format.

Primary Activities :
- Glossary Preparation.
- Linguistic check of English to respective language and respective language to English.
- Follow the company standard process for the above.
- Any change in process cannot be done. If process does not fit requirement, inform Operation Manager (OM), Chief Operation Officer (COO) for change incorporation and version change in process flow chart.
- Analyze the translated document for effort required.
- Simple words translation for customization and domain specific words.
- Checking target document accuracy with respect to source document in terms of context, grammar, flow of language.
- Verification of Back translation with respect to the original.
- Sending Daily Report to Delivery Lead (DL), Delivery Manager (DM), Assistant Operation Manager (AOM), OM, COO.
- Achieving daily target.
- Following the Linguistic Checklist.
- Maintaining the Linguistic tracker (checklist objective).
- Giving feedback on quality of document.

Secondary Activities :
- Understanding the domain, updating knowledge.
- Improving ones linguistic skills – English and vernacular.
- Updating master language glossary.
- Developing new/faster ways of linguistic checks.
- Interacting with client/Vendor to resolve any issue.
- Updating the project team or AOM or Lead on any challenges seen in the document by mail.
3) Internship Nov. 2009 – Mar. 2010
Successfully completed four months of internship at Quintiles.
Responsibilities
- Conducted basic data review on off-line PDF clinical data files.
- And created hyperlinks from Case Report Forms (CRFs’) to the relevant Data Clarification Forms (DCFs’) and vice – versa.
- Process of DCF extraction and insertion where ever necessary.
4) Clinical Research Consultant Aug. 2008 – Nov. 2009
Sysplex Bio & Clinical Solutions
- Preparation of power point slides on Clinical Research topics.
- Given training to students.
- Given presentations on Overview of Clinical Research in Colleges.
5) Quality Control Chemist Nov. 2007 – Apr. 2008
McLaren Biotech (P) Ltd.

- Sampling of raw materials
- Sampling of finished products (General Ointments, Steroids, Antibiotics, Lotions & Gels)
- Chemical analysis of various raw materials & Finished Products (e.g Povidone iodine, Neomycin, Cetrimide, methyl salicylate, nitrofurazone, chlorocresol, & many other active ingredients & exepients.)
- Maintaining Raw material reports, Packing material reports, & Finished product reports.
- Working knowledge in UV Spectrophotometer, Polarimeter, and IR for observing & comparing the intensed spots in the silver foil.
- Preserving control samples, & reserve samples
- Supervising during dispensing of raw materials
- Checking weights at the time of filling of ointments at every 30 minutes interval.
- Calibration of Balance & pH meter.
- Supervising workers and ensuring implementation of general safety measures in production.
- Imparting training to new joiners regarding standard operating procedures and safe work practices.

Education

PG Diploma in Clinical Data Management
ICRI, Bangalore
Master of Science (Biotechnology)
CMR Institute of Management Studies, Bangalore.
2009
2007
Bachelor of Science (Microbiology, Chemistry, Medical Lab Technology)
TSR & TBK Degree College, Vishakhapatnam.
2005

Technical Skills

Software
- Windows XP/ 9X
- C
- MS Office Proficiency
Proficient
Skilled
Proficient

Trainings

- Got training on Clinical Research specialization in Clinical Data Management, Oracle Clinical (OC), and Statistical Analysis Software (SAS).

Affiliations
- Art of Living Foundation : Actively involved in mobilizing people towards healthy living through meditation, yoga and spiritual cleansing.
- Participated in Annual College Symposium as a volunteer.
- LANDMARK EDUCATION : Participated and organized seminars as part of the curriculum of living.
Hobbies and Interests

- Listening music, singing, coin collection, Sports, and reading spiritual books.

[vinisha001]

Curriculum Vitae
VINISHA BHAVSAR
E-Mail : vinisha.bhavsar AT gmail.com
CAREER OBJECTIVE :
- To work in an esteemed organization where my technical knowledge, idea & ability can be utilized and expanded for organization growth.
SUMMARY :
- Around 1 Years of working experience in Clinical Data Management
- Attended 3 days comprehensive In-house training on OC
- Worked with Paper as well as EDC Study.
- A good team player with good communication skills.
TPROFESSIONALT EXPERIENCE :
1. PIRAMAL LIFE SCIENCES LTD, INDIA
Designation : - Senior Executive -Clinical Data Management
Period : - Jun 2010 – Till Date
Trained on :- Oracle Clinical:
Project on : Oncology, Diabetes, Inflammation, Devices
Responsibilities :
As a Team Member I am responsible for :-
- Perform data management tasks from study start up through database lock
- Database Designing & Testing
- Edit Checks Specifications (ECS) and User Acceptance Testing (UAT)
- Create and maintain study CRF data standard document
- Discrepancy Management System & Query Resolution
- Reconcile Adverse events (AEs) and Serious Adverse Events (SAEs).
- Ensure that all steps prior to locking the database are complete, utilizing a
CDM checklist. Review data listing programs and reviews for patient data
consistency, quality and completeness
- Successfully completed data lock for assigned study for therapeutic area of
Oncology
2. DRUG INFORMATION ASSOCIATION, INDIA
Designation : - Executive Operations & Program Development
Period : - Nov 2008 - Jun 2010
Responsibilities :
As an Executive Operations & Program Development I am responsible for :-
- Initial Designing of flyer, brochure for Conference, workshops and
courses.
- Assisting in program, workshop and courses development. Assisting in
operational activities for conference workshop and courses.
- Co-ordination with Speakers for program related activities. Planning,
coordinating all logistics, record of registration, speaker support & other
related activity for conference, workshop, seminar, courses.
- Preparing Pre & Post conference reports.
- Reconciliation of the meeting. Encouraging the Industry people,
networking with the industry people.
EDUCATIONAL DETAILS :

1. Clinical Data Management (2009 – 2010) from Clinical Research Education Management Academy
2. Post Graduate Diploma in Pharmaceutical Management (2007-2009) from Academy of Pharmaceutical Management from Indian Pharmaceutical Association
3. Bachelors in Science (2004-2007) from Mumbai University
4. Diploma in Software Engineering from Bureau of Information Technology Studies

TECHNICAL SKILLS :
Operating Systems : Windows Xp/9X, Vista
Databases : SQL Server, MS Excel
Applications : Oracle Clinical, OC- RDC, EDC

TECHNICAL COURSES UNDERTAKEN :
Diploma in Software Engineering from Bureau of Information Technology Studies
ADDITIONAL PROJECTS PROFILE :
1. Organization : Maneesh Pharmaceutical Private Limited
Subject : Quality Assurance, Q.C. and Regulatory Affairs
Synopsis of Project : Overview of Pharmaceutical Company, Functions of different
Depts such as Stores, Manufacturing of different Forms
(Solids, Liquid orals, Injectables), Packaging, Quality Control,
Quality Assurance and Regulatory Affairs.
Project guide : Mrs. Naina Waghmare
2. Organization: Bal Pharmaceutical Private Limited (Bangalore)
Subject: Quality Assurance, Quality Control, Regulatory
Synopsis of Project: During training Review of B.M.R., Annual Product Quality
Review, Process validation report/protocol etc. has been
carried out. Even the regulatory aspect is been briefly looked
into filling of document is needed in semi regulated market for
formulation
Project guide: Mr. Ramandeepsingh Bhagga (IBD Dept.) / Mr. Anil (Q.A Dept.)
3. Organization: PHARMORE RESOURCES
Subject: Market Research
Synopsis of Project:To know dentists perception about the new product launched
Project guide: Mr. Dinesh Chindarkar
4. Organization: Project done for INNOVA SOLUTION on behalf of
MERCK India Ltd.
Objective: To find out gynaecologists preference about different Material
used for Hematinic

[Guest]

S.Shamshuddin Pasha
Email Id :
shamshuddin.pasha AT gmail.com
shamshuddin.pasha2 AT gmail.com
Objective
To obtain a challenging position with a market leader that utilizes my experience in product management, sales management.
Accomplishments
Have the experience of tackling different types of issues under pressure.
Can work in any circumstance.
Know how to use my skills in various circumstances.
Every time I inspire myself and it creates a positive approach in me. Can make any deal successful.
Moreover, can do my work in a proper and an efficient way. Well versed with my work areas.
Aim :
Have all those skills related ,hence use my skills and make a successful career in Sales & Marketing field and can contribute to the development of the company.
Professional Excellence Summary
- Have adequate knowledge regarding Sales & Marketing support.
- Done extensive Researches on various measures of marketing analyses.
- Have 4yrs of experience and the capacity to adopt new concepts with due responsibilities.
Computer Programming Skills
- Diploma in Technical writing
- Known Graphics Tools : Macromedia Flash, Adobe Photoshop,
- Known Office Package : Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint, Microsoft Outlook Express
- Known Operating Systems : Windows9X, Windows2000, Windows XP, Windows Vista, MS DOS
Professional Background
2011 June - Present date : Working as the Area Sales Manager for Wipro GE- Whatman Company with the following responsibilities
- Successfully perform managerial duties
- Train new dealers and conduct company and product orientations
- Calculate and transmit weekly sales reports
- Handling Sales & Marketing for Karnataka and Kerala states
2007- 2011 – June – Worked as Area Sales Executive for Wipro-GE Whatman.
2006 -2007 : Omega Biotec – Worked as an Internee in the Diagnostic Lab. Worked in Lab & in Production Unit.
Selected Accomplishments
Market Expansion – Have streamlined Dealer –distributor business. Which has in turn increased the revenue and development of Company.
Marketing & Sales Initiatives – Have initiated the dealer – distributor Sales.
Achieved >100% Sales target for 3 years continuously .
Highlights
- Demonstrated ability troubleshooting business problems and implementing creative, highly effective solutions.
- Highly motivated, confident, organized, detail oriented, patient and disciplined.
- Able to manage multiple projects simultaneously while meeting all deadlines.
- Thorough knowledge of marketing and sales; analysis of clients' needs; devising and implementing customized solutions.
- Create and launch all consumer and retail promotions, co-promotions, corporate sponsorships, marketing collateral, advertising efforts and media relations.
Education :
MSc in Biotechnology – 2006, City College, Bangalore University
B.Sc in Microbiology – 2004 ,Al-Ameen College, Bangalore University
Languages : English,Kannada.Hindi,Urdu,Tamil,Telugu,Malayalam.

[Guest]

Pooja Jamloki
email : jamlokipooja AT gmail.com

Objective : To pursue career in the field of Clinical Research & use my knowledge to improvise skills and proven abilities in an organisation that promotes learning, motivation and teamwork and become competitive and compatible person thus making myself an asset to the company.
Educational Qualification :
- Bachelor of Science in Zoology, Botany and Chemistry in Year 2007-2010 from Hemwati Nandan Bahuguna Garhwal University Srinagar (Garhwal) Uttrakhand.
- 12th from Board of School Education Uttrakhand in 2007.
- 10th from Uttranchal Shiksha Evam Pareeksha Parishad in 2005.
Professional Qualification :
- Pursuing “Advanced Post Graduate Diploma” in Clinical Research Management (affiliated to Jaipur National University) from CREMA (Clinical Research Education and Management Academy, Bangalore).
- Advance Diploma in Software Technology in 2008-2009 from Centre for Computer Training & Research, Srinagar Garhwal.
Skills :

- Knowledge of ICH-GCP
- Clinical data management.
- Pharmacovigilance.
- Clinical Research management
- Good team player with sound interpersonal skills.
- Well versed with MS-Office & Internet Operation
- Willingness to learn ,Disciplined and methodical
Extra Curricular Activity :
- Presentation on Cardio Vascular System and a journal paper on detecting trace elements level in serum of Type-2 Diabetes.
- Active member of NSS (National Social Service)