www.siroclinpharm.com Siro Clinpharm Pvt Ltd Hyderabad : Clinical Research Associate

[deepika]

Siro Clinpharm Pvt. Ltd.
http://www.siroclinpharm.com/

Keywords: ICH GCP guidelines, Monitoring

Company Profile
SIRO Clinpharm Pvt. Ltd. has steadily built its reputation as a specialist in late stage clinical development solutions, to become one of India's largest local contract research organisations.

Established in the year 1996, it offers global bio-technology and pharmaceutical majors strong clinical trial services. With an experienced management team and an advisory board SIRO has slowly evolved as the Indian face in the field of Clinical Research.

Clinical Research Associate
Experience: 1 - 3 Years
Location: Hyderabad / Secunderabad

Job Description
-- To ensure all assigned studies follow SIRO/applicable SOPs, GCP and local regulations.
-- To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.
-- In coordination with the project manager and/or medical monitor, perform study site qualification visits. Also to participate in/conduct investigator�s meeting and site initiation visits.
-- To identify, define, coordinate and conduct site study training.
-- To prepare monitoring reports.
-- To maintain audit readiness at the site level.

Desired Candidate Profile
At least 1 yr of monitoring experience of handling clinical trials in Phase I, II, III & PMS (Post marketing studies).

Telephone: 022-25848000

Email us at : hr@siroclinpharm.com

Corporate Address
SIRO Clinpharm Pvt Ltd
DIL Premises, Swami Vivekanand Road,
Near Tatvagyan Vidyapeeth, Ghodbunder Road
Thane (W) 400 607
INDIA

Tel: +91-22-2584 8000
Fax: +91-22-2584 8475-79

[drshrikantdesai]

Dear Madam,
i wanted to apply for this job i am sending my resume from gmail account.

[Guest]

Dr Subir kumar
P.G. Hostel No 4/68
RIMS, Baritu, Ranchi 834009.
Email ID: subir_rims AT yahoo.in
Mobile no.: +91 9279028371
Objective :
To become an active member of the medical team of a Pharmaceutical Company or Clinical Research Organization where my knowledge of MD Pharmacology, Certificate course in Fundamentals of Clinical Research and Good Clinical Practice (GCP) Aarth India, along with my clinical experience can contribute towards effective medico-marketing & clinical research; with improvement of my skills.
Strengths :
- Passion for work and hunger to learn. Ability to adapt quickly to a new situation
- Winning attitude. Ability to succeed under pressure and attitude to rise to the occasion
- Excellent communication and interpersonal skills
Academic Qualification:
A] Professional Qualification:

- M.D. Pharmacology passed from Rajendra Institute of Medical Sciences, Ranchi in June 2009

- Bachelor of Medicine and Bachelor of Surgery (M.B.B.S) from M.G.M. Medical College, Jamshedpur, Jharkhand. (From 1995 to 2000, Internship completed on 28th Dec. 2001)

- Certificate course in Fundamentals of Clinical Research and Good Clinical Practice (GCP) from Academy for Applied Research & Training in Healthcare in India (aarth –INDIA).

B] Educational Qualification:
- 12th from Co-operative College Jamshedpur. (in 1990)
- 10th from Rajendra Vidalaya Jamshedpur. (in 1988)

Work Experience:

Rajendra Institute of Medical Sciences, Ranchi. (From June 2006 to June 2009)
Completed three years of training as a junior resident in Department of Pharmacology in June 2009. (M.D. Pharmacology)

Health and Family Welfare Dept., Govt of Jharkhand. (From Nov 2003 to June 2006)
Worked as Assistant Surgeon (Medical Officer) in Primary Health Center.

M.G.M.Medical collage and Hospital Jamshedpur from 2002 to 2003 worked as a .
Junior resident in department of Surgery

M.G.M.Medical collage and Hospital Jamshedpur completed Internship from Dec 2000 to Dec 2001.

TRAININGS:

- Fourth National Workshop On Basic Techniques In Molecular Biology & Bio-informatics In Pharmacogenomics organized by the Department of Pharmacology, JIPMER, & V.C.R.C Pondicherry from Aug 8-14, 2007.
- 1st Eastern regional Conference Organized by- Indian Pharmacological Society (IPS), Jharkhand Branch & Department of Pharmacology, RIMS, Ranchi on 19th to 20th April, 2008
- 2nd Eastern regional Conference & 19th Annual state conference (West Bengal branch) Organized by Central Research Institute of Ayurveda, Kolkata from 28th to 29th Nov 2008.
- 41st Annual Conference of Indian Pharmacological society, Organized by Department of Pharmacology All India Institute of Medical Sciences, New Delhi from 18th – 20th Dec 2008.
PAPER/ ABSTRACT PRESENTED:

Hypoglycemic effect of Holarrhena antidysenterica in streptozotocin induced diabetes albino rat”. Presented in 41st Annual Conference of Indian Pharmacological society, Published in Indian Journal of Pharmacology, vol-40, Dec-2008 supplement

DISSERTATION:

Comparative study of hypoglycemic effect of Holarrhena Antidysenterica, Eugenia Jambolana and Glibenclamide in experimentally induced diabetes in albino rats”
ACHIEVEMENTS:

- Chief organizer of 1st Eastern regional Conference Organized by- Indian Pharmacological Society (IPS), Jharkhand Branch Ranchi on 19th to 20th April, 2008

IT SKILLS: Windows- XP; MS Office- word, excel, PowerPoint; Internet.
REGISTRATION: Jharkhand Council of Medical Registration (No- 1374) & Bihar council of Medical Registration ( No- 32962)
PROFESSIONAL MEMBERSHIP: Indian Pharmacological Society (Jharkhand branch).
LANGUAGES KNOWN: Fluent in English & Hindi
EXTRA-CURRICULAR ACTIVITIES: Got prizes at interschool and intercollegiate level in Sports and other extra-curricular activities. (Mr. Fresher at M.G.M.Medical College in 1995) Organized annual blood identification camp in 1998 in M.G.M. Medical College.

HOBBIES: Playing cricket & chess.

DATE OF BIRTH: 02nd Jan 1973.

MARITAL STATUS: Married.

REFERENCE: Will be provided if required
Declaration :

I hereby declare that all the above details are true to the best of my knowledge and belief.

Place: Ranchi Subir Kumar

[Guest]

CURRICULUM VITTAE
IMRAN A.BASIT PATEL
Email : december1_patel AT yahoo.co.in
OBJECTIVE
- To be a part of result oriented professional team that provides a challenging innovative work environment and opportunities for career and professional development.
PERSONAL STRENGTHS AND ATTRIBUTES
- Excellent temperament to multi-task and coordinate various activities under high pressure and time constraints.
- Adjusting to new situations coupled with excellent communication and relationship.
- Ability to work independently and effectively as a good team leader.
- Good analytical and organizational skills.
AREA OF INTEREST
- Clinical Research and Clinical Data Management
- Regulatory affair
DISSERTATION TOPIC
- Evaluation of protective effect of Punica granatum against doxorubicin induced cardiotoxicity in rats
.
Course University/Board College Result Remark
M.Pharm
Second year
(IVth semister) Dr. BAMU, Aurangabad
Y.B. Chavan College of Pharmacy, Aurangabad
- Appeared
M.Pharm
First Year
67.63 %
First Class
Bachelor of Pharmacy North Maharashtra
University, Jalgaon J.Z.M.D.S,COP Mamurabad(Jalgaon) Maharashtra 64.48 % First Class
D.Pharmacy M.S.B.T.E. Mumbai A.I.T`S Institute of Pharmacy, Malegaon (Nashik) 67.20 % First Class
H.S.C. Nasik Board A.G.R.G.Jr. College, Shendurni,Dist.Jalgaon 63.17 % First Class
EDUCATIONAL DETAILS
CONFERENCE/SEMINAR ATTENDED
- Participated as a scientific poster presenter in Rx- Tech Festival 27th Feb 2011 organized by IPA-SF-MSB at BCP, Kalina, Mumbai.
- University of Pune sponsored seminar on “Current trends in Preclinical Pharmacology”on 12th January 2011 organized by A.I.S.S.M.S. College of Pharmacy, Pune.
- ICMR sponsored two days seminar on “Recent trends in Clinical Research” on 21th & 22 th April, 2010; organized by Y.B.C.C.P,Aurangabad.
- National seminar on “Drug Regulatory Affairs” on 13th March 2010; organized by Y.B.C.C.P,Aurangabad.
- Attended 62th Annual Conference of Indian Pharmaceutical Congress, Manipal University, Manipal, 2010
PROFESSIONAL SKILL
- Having brief knowledge of guidelines related to clinical trial such as ICH-GCP, Institutional ethical guidelines for bio-medical research and human participant (ICMR), Schedule Y etc.
- Good knowledge in handling bio analytical instruments like Autoanalyser, cooling centrifugation etc.
- Expert in handling of rats and mice, expert in oral, i.p., s.c. dosing of animals, rats & mice surgery.
- Expert in pharmacological screening studies in diabetes mellitus, inflammatory & behaviour pharmacology.
- Expert in handling of CNS Apparatus (Elevated plus maze, Hot plate apparatus, Tail flick apparatus, Pole-climbing apparatus and actophotometer).
- Expert in cannulation of carotid artery, cardiac puncture in rat.
- Plethysmometer for measurement of paw edema volume in experimental animals.
COMPUTER PROFICIENCY
- Windows operating systems and application software : MS Office.
- Instat for statistical analysis.
- Scientific data retrieval from various Internet portals like Sciencedirect, Pubmed, Google etc.

[Guest]

Resume
Naresh Kiran Kumar Reddy.Y
e-Mail ID : yelkotinareshreddy AT gmail.com
_______________________________________________________________
OBJECTIVE :
- To obtain an opportunity to improve knowledge and practice considering my areas of interest and achieving my ultimate professional ambition.
WORK EXPERIENCE :
- Presently working as a Trainee Clinical Research Coordinator at Krishna Institute of Medical Sciences, Hyderabad since January- 2011.
ACADEMIC QUALIFICATIONS :
Qualification Institution Year Remarks
Secondary School Leaving Certificate Srisaraswathishishumandir, Narayanpet(town),Mahabubnagar (district), Andrapradesh 2001 77.3%
Intermediate Sri prathibha junior college,Kurnool road,Ongole.
2003 77.5%
Bs.c Nursing Apollo College of Nursing,JubileeHills, Hyderabad-500096 2010 60.4%
CONFERENCES/WORKSHOP ATTENDED :
CONFERENCE INSTITUTION YEAR
Conference on Caring, sharing inspiring core values in holistic nursing. Mount Abu, Rajasthan. 2009
State conference on “Critical care nursing”. Apollo College of Nursing, Jubilee Hills, Hyderabad 2007
National conference on “Health wellness and medicine” Banjara hills, Hyderabad 2007
AREAS OF PRACTICAL EXPOSURE :
Clinical areas from
- Apollo Hospitals, (Emergency Critical care, Medical & Surgical Nursing, Administration),
- Gandhi Hospitals (Obstratic, Gynic & Advance Med-Surgical ),
- Nijams institute of Health sciences( Nims Hospitals),
- Krishna Children’s Hospitals (Pediatrics),
- Asha Hospitals (Psychiatry).
CLINICAL RESEARCH :
- Design and conduct of phase I-IV trials
- ICH-GCP guidelines, schedule Y
- Informed consent process
- I.V.R.S (Intra voice response system)
- Ethics committees and regulatory approvals
- Pharmacovigilance
- Clinical Data Management
COMPUTER SKILLS :
Operating System : Windows/98/2000/XP/2003
Software Testing : Manual Testing, Automation (QTP), QC, LoadRunner
Programming Language : C
Database : SQL Server
Web Technologies : HTML
Application Packages : MS-Office and Internet Concepts
PERSONAL STRENGTHS :
- Hard working and dedication for given task.
- Can communicate well.
- Ability to work under pressure.
- Comprehensive problem solving capabilities.
- Always ready to learn.
- Friendly, enthusiastic and persuasive in critical situations.
PERSONAL INTERESTS :
- Listening to music
- Gardening
- Cooking

[Guest]

CURRICULUM VITAE
Email : neelam7034 AT gmail.com
PARMAR NEELAM NAGINBHAI
CAREER OBJECTIVE :
Looking for a challenging position where strong organizing, leadership abilities,
team work could be fully utilized and which will lead to further development in my
professional growth and personal satisfaction.
PERSONAL STRENGTHS :
A dynamic worker and systematic learner who likes to participate in various
development activities of the organization and believes in positive change through an
efficient managerial system.
EDUCATIONAL QUALIFICATION :
- Bachelors in (Chemistry) from Mumbai University Passed with Ist Class.
. Masters in clinical research and regulatory affairs from Sikkim Manipal
University , Nov 2010.
ADDITIONAL QUALIFICATION :
COMPUTER EXPOSURES
SOFTWARE :
Packages : MS-OFFICE & Internet.
WORKING EXPERIENCE : 6 Months in CIPLA OMNICARE AS A MEDICAL
EXECUTIVE
6 Months Advance Vital Enzymes as Business Development Executive
ACHIEVEMENTS : 1. Achieved Monthly budget consecutively for 1 year.
2.Developed KOL (key opinion leader) with Dr .Parulkar (MS)HOD
for successful group meeting with Drs for the Brand Cefstrong CV, resulted in growth
in business.
3. Done 2 months internship in Medical Oncology Department from
Prince Aly Khan Hospital , Mumbai.
4. CDM training in Nexus CRO from May 2011 till date.
Knowledge of Clinical Research
Schedule Y
Roles & responsibilities of Clinical Research Associate and Clinical Research
Coordinator.
ICH-GCP Guidelines
Clinical Data Management
§ CDM Process
§ Validation Process
§ Acquisition or collection of Clinical trial data
§ CRF Designing
§ CRF Development & Tracking
§ Data Entry
§ Annotation

Software Knowledge :
§ SQL Basic
§ Graph pad prism
§ MS-Excel

[USHNISH DAS]

Ushnish Das.
Email id : 1. Ushnish.ushnish AT gmail.com 2. gaang_salik AT rediffmail.com

OBJECTIVE
To use my knowledge in a way that delivers tangible value to my employer while building the strength, I’ll need to become a successful & competent CLINICAL RESEARCH ASSOCIATE. My immediate aim is to develop a first hand understanding of the certain duty by being a part of your program.
ACADEMICS
PG Diploma in Clinical Research Associate [2007-08] with 1st class (81.5%) from American Institute of Pharmaceutical Technology, New Jersey, USA {Kolkata campus}
Undergoing M.Sc Zoology through Distance Education from University of Madras of session 2010 – 2012.
B. Sc - [Calcutta University] - [2004-07]
Certificate course[Basics, MS-Office & Internet] - CMC Ltd. – [2006]
EXPERIENCE
1. Senior Clinical Research Assistant and Institutional Ethics Committee Coordinator at Chittaranjan National Cancer Institute, Kolkata [RCC] from April 09.
2. Clinical Research Coordinator at Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata [November 2008 - April 09]
Previous participation in clinical trials
Indication of Trial Clinical Phase of Trial Role in Trial Year in which trial was conducted
Ca – Breast II 2008
Mantle Cell Lymphoma III 2008
Acute Lymphoblastic Leukemia III/(BE) 2008
Non small cell lung cancer III 2009
Non Hodgkin’s Lymphoma II 2009
Venous Thrombo Embolism due to chemotherapy in solid tumors III 2009
CML-cp/GIST IV 2009
Ca - Stomach III 2009
Bladder Cancer III 2009
Non small cell lung cancer II 2009
Non small cell lung cancer IV 2009
Refractory/resistant/relapsed solid tumor IV 2009
Multiple Myeloma I b 2009
Ca – Breast III 2010
CA - Stomach III 2010
Non Small Cell Lung Cancer II 2010
Non Small Cell Lung Cancer IV 2011
Anaemia due to chemotherapy in Non Small Cell Lung Cancer III 2011
Bladder Cancer III 2011
National Cancer Registry Program - Indian Council of Medical Research.
CML & GIST - GIPAP program - Novartis Onco. & Max Foundation.
Arranging financial aid for patients from different Gov. & non Gov. philanthropic organizations.

Professional Knowledge : 1.Clinical trial mgmt.(monitoring) 2. Clinical site mgmt. 3. Clinical data mgmt.(validation) 4. ICH-GCP 5. CRF formatting 6. Basic Pharmacology 7. Regulatory affairs for IND/NDA. 8. Schedule-Y 9. ICMR guidelines 10. QC & QA
Practical Skills :-research subject counseling, assist IC procedure, review inclusion & exclusion criteria, QOL procedures, IP dispensing & accountability, process blood samples, IVRS/IWRS communication, complete source documents & CRF{paper & electronic(RDC-Oracle, Medi-Data, Inform & Pheedit)}, Data Query resolution, familiar with ICD – Oncology, CTCAE guidelines, NYHA classification, ECOG PS, TNM staging & RECIST criteria, review pathological reports, well versed with Central lab & radiographic image transmitting procedures, IRB correspondence, arranging meetings, evaluate & review potential clinical trials, complete feasibility questionnaires, assist regular SSV,SIV,SMV, SCV & sponsor audits, assisting budgetary requirements.
Lead of a coterie of three junior coordinators.
Competent in working under guidelines & procedures of leading Sponsors & CROs [viz. Quintiles, ICON, Lambda, Ranbaxy, Siro, Chiltern, Sanofi Aventis, Eli Lily, Cadila, Amgen, Roche, J&J, GSK etc.]
Projects : 1> BA & BE. 2> Bio diversity & env. threats of wetland ecosystem.3>Relative abundance and conservation status of fishing cat in West Bengal.
Seminars: ICH GCP - Eli Lily & Company IM – 1. GSK 2. Cadila Pharmaceuticals Ltd.

[Guest]

KRANTHISHREE YADAVALLI
E-mail : sharmakranthi AT gmail.com

SUMMARY : 6 Years of experience in Clinical Data Management.

OBJECTIVE
I am looking for a challenging, growth-oriented and professionally rewarding assignment in emerging technologies from a professionally managed group, which will effectively utilize my skills and techniques in the most appropriate way.
The 6 years 6 months Pharma experience had strongly enabled me to grow in any Organization as the roles and responsibilities which I took it up are wider both on technical and managerial end.
My experience had also enabled me to learn the Business understanding of any Organization as a first and foremost priority and utilize my skills and techniques in the most appropriate way
EDUCATIONALQUALIFICATION
Masters in Computer Science (Distance Education)-
Institution :SikkimManipalUniversity
Bachelor in Commerce(Correspondence) –
Institution : BangaloreUniversity.

Pre-Degree (Diploma in Commercial Practise) –
Institution : VET BVL Polytechnic, J.P. Nagar, Bangalore
Secondary School Examination –
Institution : SharadaStreeSamajHigh School, Royan Circle, Bangalore.
.
EMPLOYMENTHISTOR Y
Novartis Healthcare Pvt Ltd
June-2010-June-2011 Pharmacovigilance Data Manager
1. Performed User Acceptance Test for ARGUS SAFETY INTERNAL REPORTS DB
2. Involved in writing Testing comments, suggestions and observations if necessary while performing testing
3. Interacted with cross-functional teams and fixed the timelines to put the respective testing DBs into productions
4. Understood and translate data retrieval from ARGUS Safety and Other Database need into query request from Oracle Server through TOAD, creating query criteria by writing SQL and PLSQL Statements, retrieve data from the safety database(i.e. ARGUS SAFETY, TOAD Database) and provide the results to internal staff or external line functions and Food Development Authorities.
5. Perform QC check on data retrieved; Identify errors/inconsistencies in outputs and resolve them or initiate their resolution.
6. Generate regulatory reports standard reports, tabulations, graphs and retrievals in preparation for regulatory submission such as-Periodic Safety Reports(PSUR),Addendum Reports(AR), Annual Safety Reports(ASRs for product safety analysis), Annual Product Reports(APRs for product analysis which will enable PSUR Writers, CSR Writers and for Risk Management Anaylsis
7. Provides on an ongoing basis the regular reports and also as a special request may be on Users information, Products information, Adverse Events Information etc. The regular reports listed as follows :-The productivity reports of users who captured data in ARGUS SAFETY DB, Quality Control Sampling Data, Compliance Data according to business need and other reports as and when needed.
8. Coach, train and mentor new Safety Data Management personnel as appropriate.
9. Lead, coordinate or support data management initiatives as and when needed.
10. Testing and validation activities to support operational change requests and IMS IT projects.
11. Development, testing and validation of new reports for the IMS STAR data query and analysis tool.
12. Electronic unblinding of relevant SAEs from clinical trials in the safety database, as appropriate.
Quintiles Technologies (I) Pvt Ltd
Jan 2005 – June2010
Clinical Data Assistant II (Data Entry Lead)
- Performed Alpha Testing in Oracle Clinical for 4 studies
- Performed Beta Testing in Oracle Clinical for more than 8 studies
- Performed Alpha and Beta Testings in Clintrial(all versions) for more 8 studies
- Knowledge gained on performing User Acceptance Test INFORM, OC RDC and RAVE
- Involved in writing Testing comments, suggestions and observations if necessary while performing testing
- Interacted with cross-functional teams and fixed the timelines to put the respective testing DBs into productions
- Serving as a Data Entry Lead for 11 studies of various indications
- Handling all phases of data management activities from study start up to database close
- Performed Data Base designing – “Clintrial”
- Have designed the Database for 4 studies within timelines and excellent quality and received awards for the same.
- Database designing included tasks such as Page Layout Designing, Study Book Designing, Edit Checks preparation and Form Controls
- Performed Data management tasks like :
- Preparing the Data Management Plan
- Create Data Entry and Tracking Guidelines.
- Knowledge gained onDiscrepancy management – Manual Query generation, Reviewing answered queries and closing the answered queries.
- Knowledge received from Trainings in Medical Coding, SAE Reconciliation.
- Ensure that all steps prior to locking the database are complete using DM checklist.
- Performed QC of the Database during a study Close-Out.
- Conducting the Interviews and giving training to new employees.
- Performed all other duties as assigned
- Attended Trainings through Desktop Sharing Sessions on Third Party Reconciliations
- Served as a Data Manager for two studies
- Performed data management tasks like discrepancy management, query generation and updating the same.
- Perform data review tasks independently.
- Preparing study status report every fortnightly.
- Undergone Knowledge Sharing and Reverse Knowledge Sharing Client specific to demonstrate the detail understanding on Third Party Reconciliation, Data Entry Guidelines Briefing of the study and the applications used.
- Perform quality control procedures.
- Participate in monthly teleconference with the client/monitors to discuss study status.
- Understand and comply with core Standard operating procedures (SOP) and Standard working instructions (SWI).
- Performed data management tasks like discrepancy management, query generation and updating the same.
- Accurate tracking of all CRFs and DCFs and identify any missing information
- Review and identify inconsistencies within the final data tables, listings, and report.
- Performed all other duties as assigned.
- Interacting with Programmers introduced a new Oracle Form called Oracle Clinical Automated Report
- Knowledge received on writing SQL Queries on RXA and RXC Schemas in Oracle Clinical
- Attended a Training on Basic SQL/PLSQL conducted by the Organization
PROJECTEXPERIENCE
Phase/
Date Therapeutic Area Number of
Countries Number of Sites & Patients Description of Responsibilities and Tasks
Phase I Obesity 35 Sites - Performed DB Testing on Clintrial Platform sponsored by PHASE FORWARD.
Phase I Blood Clotting - Performed DB Testing on Clintrial Platform sponsored by PHASE FORWARD.
Phase IIIB/IV Type 2 Diabetes Mutiple Countries 722
7952 subjects - Performed data management tasks like leading a Team of 20 members in monitoring the data capture activities performed by them.
- Adapted to New Platforms like Fortis(an Image Repository)
Phase II/III Metastatic Colorectal Cancer
175 Sites & 100 Patients
88 Sites 300 Patients
15 Sites 400 Patients
180 Patients - Performed data management tasks like leading a Team of 20 members in monitoring the data capture activities performed by them.
- Adapted to the Imaging System which is loaded by the Site in Oracle Clinical Database itself
- Client Specific DMP Documents
Phase III Allergies 8 Countries 4 Sites - Performed data management tasks like leading a Team of 10 members in monitoring the data capture activities performed by them.
- Updating, Running Reports
- Adapted to a new data management activity called Third Party Reconciliation

STRENGTHS
1. Strong communication, interpersonal, learning and organizing skills matched with the ability to manage stress, time and people effectively.
2. Quick learner and self-motivated, Enthusiastic and innovative.
3. Achievement oriented with excellent people management skills and an ability to manage change with ease.
4. Proven Strength in problem solving, coordination and analysis.
5. With the expertise that I have in Clinical Data Management using various applications like Oracle Clinical, Clintrial, Inform, OC RDC. I have a strong desire to learn all the new applications which organization is introducing in Clinical Domain.
6. Worked on Post-Marketing Surveillance studies
7. Delivered the PSUR, AR, ASR, APR reports which are necessary for writing (Periodic Safety Reports PSURs, CSR and also Risk Management Analysis) and also Regular Reports like Productivity, Quality Control Sampling, Compliance Reports according to business purpose in time.
COMPUTER SKILLS(Technical) :
- Basics of SQL, PLSQL and MS Office
COMPUTER SKILLS(Pharma) :
- EDC Software’s (PHASE FORWARD-INFORM,ORACLE CLINICAL/OCRDC And CLINTRIAL)
- Working knowledge of MS-Word, MS-Excel, MS-Power Point, Good at EXCEL
- Worked on tools like TOAD, SQL Navigator and SQL *Plus
- Worked on ARGUS Safety Database
OTHER SKILLS and ABILITIES :
- Applied experience in data management using ORACLE CLINICAL, CLINTRIAL, and other comprehensive Clinical Database Management System.
- Acquired knowledge on INFORM and OC RDC Platforms by attending Trainings and Sessions
- Received Extensive knowledge on SQL and PLSQL by attending the Training conducted by the Organization under a program “PROGRAMMING SKILLS DEVELOPMENT CENTER”
- Extensive use of Good Clinical Data Management Practices within FDA guidelines.
Have strong computer skills with experience in database reporting and use of logical expressions.
- Demonstrated ability to manage multiple projects.
- Good written and verbal communication and interpersonal skills.
- Good diagnostic and troubleshooting skills.
- Able to adapt and respond quickly to changing situations.
ACHEIVEMENTS
- Received Appreciation Award for handling the Regular Reports.
- Received Work Worth Doing Special Achievement Customer Service Awards for performing Database Designing for 4 studies with 100% quality
- Received Work Worth Doing Special AchievementObservationalAward for suggesting an idea for additional of field while Database Testing
- Received Work Worth Doing Special Achievement Observational Award for suggesting an idea to have Yes /No Responses to the Affix Drug Label Field which was missed in CRF Annotation
- As per Annotation, Programmer of one of the study had designed a field without inserting hyphen for a Lot Number. Escalated the issue to the Study Team and confirmed to add a hyphen between the Lot Number at the time of Beta Testing
- The Project team awarded an Special Achievement Eureka Idea for escalating above mentioned issue
- Received an Appreciation Mail from the Project team on adding the above mentioned field in the Database because the field was important for Biostatistician Analysis
- Received Work Worth Doing Special Achievement Customer Service Awards for leading multiple projects in different Indications and for meeting timelines
- Work Worth Doing Special Achievement Customer Service Awards for Locking the database of Multiple projects
- Received appreciation mail from Senior Management-DM and Project Manager towards handling the multiple projects.
- Received Work Worth Doing Applause Customer Service Award for utilizing my time in meeting the Timelines and Planning towards the growth of personal development

[sowmya.cynthie]

CURRICULUM VITAE
Sowmya.R.

Email : sowmya.cynthie AT gmail.com
Objective :
I do seek a position as a valuable member of your organization that utilizes my skills, knowledge, work ethic, achievements and abilities towards its growth. To be a part of the team that works dynamically towards the organization and gains satisfaction thereof..
Professional Summary :
- Ten months of experience as a Clinical Data Coordinator.
- Excellent communication, listening and interpersonal skills.
Professional Experience :
Bio-Med Informatics, Medwin hospital, Hyderabad,(Nov 2010-till date) as Clinical Data Coordinator :
Roles & Responsibilities :
- Responsible for all data coordination activities and data validation on CDM.
- Handle the tasks of updating and reviewing data in the clinical databases based on resolved data enquires.
- Performing the tasks of maintaining the system in order to track the data management process.
- Perform the tasks of creating and maintaining study files and . Other appropriate study documentation
Education Qualifications :
Bachelor in Pharmacy
Rajiv Gandhi University of Health Sciences,
Karnataka
Aggregate : 60.2%
Board of Intermediate Education
Premier Junior College,
Kurnool
Aggregate : 60%
Certifications :
Clinical research, ICH-GCP guidelines, clinical data management and SAS clinical certified by Medwin Hospitals, Hyderabad.
Project Details on Clinical Research , SAS and CDM :
I have been extensively involved in “randomized parallel double blind clinical trial on type-II diabetic patients” .It comprises of clinical data management environment to manage the clinical data as per requirements defined in protocol in accordance with regulatory affairs. Responsibilities include handling source documents, informed consent forms, CRFs by maintaining the ethical guidelines .I have been involved in scientific literature survey .I have also been involved in statistical application to find out the safety and efficacy of the drug and also been extensively involved in the preparation of documents related to clinical trials, CDM and statistical reports. I was also involved in CRF designing, Data Validation, Query Management, Safety Data Management to produce the desired AE/SAE reports and managing the clinical data intermittently as per 21 CFR USFDA guidelines.
Proficiency :
- Dedicated Knowledge on Good Clinical Practices (GCP), 21CFR Part11, FDA regulations and guidelines in new Drug Development, Clinical phases, Schedule YGMP and ethical guidelines.
- Comprehensive Knowledge of data management practices and research protocols.
- In depth Knowledge of the methods and procedures of clinical trial design.
- Interest in learning new advancements in the field of Clinical Research.
General Skills :
- Excellent communication, listening and interpersonal skills.
- Committed to growth, inspired to learn.
- Flexible, adaptable & a good team player.
- Personal & Professional confidence.
CAREER VISION
- To work in an organization this gives me responsibility and recognition.
- To become a highly skilled professional in an organization and develop an ability to adapt to today’s ever-changing intellectual and technology driven environment.

[Guest]

RESUME
Neela Madhaba Sahu
E.mail :sahu.neela AT gmail.com
Carrier Objective :
To seek challenging avenues where my educational potential match the organization growth and to endeavor towards achieving vision of the organization through personal improvement and teamwork.
Academic Qualification :
Examination Institute Board Year Of Passing % Acquired
10th Medical Campus HSE, Odisha 2005 75
12th Berhampur University CHSE, Odisha 2007 42

Professional Qualification :
Examination Institute University Year Of Passing CGPA
B-Pharm Roland Institute of Pharmaceutical Sciences BPUT, Odisha 2011 7.0(CGPA UPTO 7th SEM.)

Experience : 3 months work experience in Clinical pharmacology department of G.V.K Biosciences, Hyderabad as a Research Assistant.
Computer skills : Microsoft office, Internet, C +
Project Undertaken : I have done the project on the synthesis and antimicrobial activity of Isatin-3- Hydrazones.
Machines Handled : HPLC, UV Apparatus, Ball mill, Single Punch Tablet Apparatus
Extra activity: Man of the match in Cricket in university level

[Guest]

VISHNU VARDHAN K.
E-mail : vishnsri AT gmail.com
- To use my expertise gained through experience and to attain new heights of excellence through effective performance in the responsibilities assigned, thereby helping the organization to achieve a commendable position in the Industry.
ACADEMIC QUALIFICATIONS :
- Pursued Bachelors degree in Industrial Biotechnology from Dr. M.G.R UNIVERSITY Chennai during the period 2005 to 2009.
- PG Diploma in clinical research from Lotus Clinical Research Academy in Bangalore 2011.
PROFESSIONAL EXPERIENCE :
- Worked as CRC for a phase – III Dermatology study at J.T.Skin Care Centre, Chennai, Tamilnadu.
- Worked as CRC for a phase – III Cardiology study at Vijan Cardiac and Critical Care Centre, Nasik, Maharashtra.
- Responsibilities /Activities as a CRC :
- Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principles.
- Ensure that IRB approval of protocol and informed consent form is obtained prior to initiation of the study.
- Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
- Confer with subject and physician to explain purpose of study. Explain diagnostic procedures and method of treatment to answer subject and family concerns. Obtain written consent for subject to participate in a study prior to initiation of any protocol procedures.
- Maintain accurate records of the receipt, inventory, and dispensation of study drug and materials. Work with the nursing staff to administer study drug to research subjects.
- Obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
- Collect pertinent information and data from subject charts and records, subject interviews, and other sources. Complete case report forms (CRFs) in accordance with research protocol guidelines. Inspect CRFs, source documentation, and study files to ensure completeness.
- Review CRFs, source documentation, and study files with representative from sponsor, consortium, or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs and submit requested documentation in a timely manner.
- Comply with standard operating procedures of the sponsor, institutional review board (IRB), and consortium involved with the trial. Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and consortium.
- Site close out procedure and archival process of the documents after the site close-out.
CORE COMPETENCE :

- Well versed with the flow of clinical research process from the protocol development stage to the process of conduct of the trial and the study close out.
- The ability to overcome the difficulties in the conduct of the trial as per the protocol and to handle site related activities like subject counseling and monitor the adverse events during the trial process and follow-up of the subjects.
- Experience in CRF using e-CRF during the dermatology trial and in handling patient data in paper as well as electronic format.
- Completed “Introduction to ClinPhone Kendle College online course”.
SEMINARS PRESENTED :
- Presentation on topics, Ethics Committees in clinical research, Roles and Responsibilities of Monitor, Protocol (ICH E6), Regulatory Affairs in CR (India) during the course of APGDCR at Lotus Clinical Research Academy.
TRAINING AND WORKSHOPS ATTENDED :
- Trained in ICH-GCP, Schedule Y, ICMR, US-FDA, EMEA guidelines for clinical research as part of my course of APGDCR at Lotus Clinical Research Academy.
- Trained in basics with operations in Oracle Clinical 4.5.3 (RDC) during APGDCR at Lotus Clinical Research Academy
- Attended various workshops on ICH- GCP, ICMR and Schedule Y while pursuing APGDCR at Lotus Clinical Research Academy at Lotus Clinical Research Academy.
TECHNICAL SKILLS :
- Knowledge about MS office including MS Word, Excel, PowerPoint.
- Basics in operating Oracle Clinical 4.5.3 for Remote Data Capturing in clinical trials.
- Well versed with internet.

DECLARATION :
I declare that the above furnished information is correct up to my knowledge. I am looking forward to take-up a challenging job where I can do my best, which provides growth prospects.
Place : Hyderabad.
Date : (Vishnu Vardhan K.)

[Guest]

Hi ,
I am very much interested to work in clinical trials department, but i am a fresher and I ave completed by B.pharm in the year 2010 with an aggregate of 77%