Makro Technologies Pvt Ltd Hyderabad : Clinical Data Validator

[Admin]

Makro Technologies (P) Ltd.
http://www.makrotech.com

Keywords: oracle clinical, data validation , data management

Designation: Clinical Data Validator - MakroCare
Experience: 3 - 6 Years
Location: Hyderabad / Secunderabad
Education: UG - B.Pharma - Pharmacy,B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology
PG - Any PG Course - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
Posted Date: 05 Dec 2008

Job Description
3yrs of Phase I-IV pharmaceutical industry/CRO data management experience with Oracle Clinical & knowledge of GCP is required.Exp of electronic data capture & data validation programming is required.

Desired Candidate Profile
Ensure that all data related activities are performed according to protocol, GCP & approved SOPS.Participate in the development, implementation,& continuous improvement of SOPs, work instructions & reporting/data standards.

Company Profile
IT and Scientific services firm with 500 employees in US are in business for over 10 years. It is recognized as one of the 500 fastest growing technology firms in US & one of the FAST 50 technology firms in NJ - Awarded by Deloitte for 2005,2006,2007

Executive Name: G N Rani

Address:
Not Mentioned

Email Address: careers@makrotech.com

Telephone: 91-040-44335555

Reference ID:
CDV/Care

[laxmi.sri_999@yahoo]

CURRICULUM VITAE

SRI LAXMI GINGALA
Email: laxmi.sri.999 AT gmail.com
Saidabad, Hyd-500059


OBJECTIVE:
To obtain a position in clinical data management industry where I can effectively utilize my expertise in medical transcription and infuse best of my skills and knowledge and to be instrumental in the organizational growth with unwavering commitment to excellence and dutiful respect for compliance in all regulated environment.

EDUCATIONAL QUALIFICATIONS:

- B.Sc. (Microbiology, botany, & Chemistry) from Osmania University with 67% marks.
- Intermediate (Bi.P.C.) with 80% marks.
- SSC from SSC Board Of Andhra Pradesh with 84% marks.

TECHNICAL SKILLS PROFILE:
Operating System : Windows 98/2000/XP

Office Automation Tools : SAS (SAS base, SAS/graphs, SAS/stat, SAS macros)
ORACLE 9i (SQL, PL/SQL)
MSOFFICE (MSWord, MS-Excel, Power Point, &
MS-DOS)
Application Packages : Openclinica & Oracle Clinical

PREVIOUS WORK EXPERIENCE:

1. Worked as a medical transcriptionist for two years in BNR Udyog Ltd.
2. Worked as an editor in the same company for three years.
3. Did home editing for a year.

ADDITIONAL QUALIFICATIONS:

1. Good knowledge of medical terminology and patients’ data.
2. Good typing skills (>50 wpm).


TRAINING UNDERWENT:
a. Clinical research training:
- Introduction to drug discovery and development
- ICH GCP (Good Clinical Practices)
- Schedule Y
- Investigational Review Board/Independent Ethics Committee (IRB/IEC)
- Investigator Responsibilities
- Sponsor Responsibilities
- Investigators Brochure , Clinical Trial Protocol and Protocol amendments(s)
- Essential Documents for the conduct of a clinical trial ( Trial Master Files)
- Designing ICD, CRF logs
- Informed Consent Process
- Maintaining logs at Study Site
- CRA Responsibilities:
o Pre study site visit, Site initiation, Interim Monitoring Visits, Site close out
o Source Data Verification
o Study Drug Accountability
o DCF (solving queries)
o Safety Reporting (E2A Guidelines)Submission of documents to Regulatory and Ethics Committee
- CRC Responsibilities

b. Clinical Data Management training:
- Oracle clinical Database design documentation, Global library objects(Discrete Value groups, Questions, Question groups)
- Creation of Data collection modules
- Assigning modules to Data collection instruments
- Writing Edit checks
- Data entry process (single, double open, double blind)
- Data entry guidelines (Study specific, General)
- Data validation process (Page review, Discrepancy management in Discrepancy database)
- Data Validation guidelines (Study specific, General)
- Addressing discrepancies like University, Multivariate, Manual
- Data closure procedures
- 21 CFR part 11
- Good Clinical Data Management Practices
- CDISC

Worked on OpenClinica Software:

- As Business Admin, trained on how to Administer Users, Subjects, Studies, CRF’s.
- As Manage Study, trained on Manage Users, subjects, Sites, Event Definitions, CRF’s, View Study Events, Discrepancies, & Groups.
- Also on Extract Data and Submit data.
- Study setup
- Protocol configuration
- eCRF Designing, Open clinical database design documentation, Library objects (Sections, Groups, Items)
- Creation of Sections
- Assigning Sections to Events and Study
- Writing Edit checks
- Data entry process (single)
- Data validation process
- Locking process
- Data extraction
CURRENT CTC: 2.5 LPA in medical transcription field.

EXPECTED CTC: 2.5 LPA.

TIME TO JOIN: June 2009

PERSONAL ATTRIBUTES:
- Ability to easily grasp and adapt to fast changing technological trends.
- Holistic approach in problem solving.
- Good analytical and logical skills.
- Comprehensive problem solving abilities, excellent verbal and written communication skills, ability to deal with people diplomatically.
- Hard cum smart worker.
- Self-disciplined and loyal to the organization

PERSONAL PROFILE:
Father’s Name : Satyanna G.
Date Of Birth : 23-07-1978
Religion : Hindu
Nationality : Indian
Gender :
Martial Status : Married
Languages Known : Telugu (Read, Write &Speak)
English (Read, Write &Speak) and
Hindi (Read, Write &Speak)

DECLARATION.
I assure that the information furnished above are true, complete, & correct to the best of my knowledge.

Date:
Station: Hyderabad (SRI LAXMI G.)

[rahulmetangale]

Dear sir,
I, Rahul R. Metangale have completed my M.Pharmacy in Pharmacology in July'09 from SVKM's NMIMS University, Mumbai. I have gained first class (CGPA 3.12 outof 4) in the coarse. I have done my research project of 7 month in Wockhardt Research Center, Aurangabad in Safety Pharmacology and DMPK Department.
I am sending this application for the post of Medical Records Manager in your organisation. If I would be given an opportunity to work, I will work with dedication to contribute to my fullest for the growth of the organization.

Thanking you.
Rahul R. Metangale,
M.Pharm.(Pharmacology),
NMIMS, Mumbai.
Mob. No. 09975763229
E -mail: rahulmetangale AT yahoo.co.in , rahuldreams2011 AT gmail.com

RESUME

RAHUL RAMESHRAO METANGALE
M.PHARM. (PHARMACOLOGY)
Email: rahulmetangale AT yahoo.co.in
Mobile No.: 09975763229 DOB: 03/04/1985

OBJECTIVE: To pursue a challenging job and excel at it, to serve the organization with my resourceful and innovative qualities and hard work, and to reach a good position in my respective field of service.

EDUCATIONAL QUALIFICATION:
SESSION COURSE UNIVERSITY/BOARD PERCENTAGE/ Cumulative Grade Percentile Average
2007- 2009 M.Pharm. (Pharmacology) Narsee Monjee Institute of Management Studies, Mumbai (Shirpur campus). 3.12 out of 4
2003-2007 B.Pharm. Sudhakarrao Naik Institute of Pharmacy, Pusad.(M.S.) 62.87%
2001-2002 H.S.S.C. MSBSHSC, Pune 72.00%
1999-2000 S.S.C MSBSHSC, Pune 74.94%

KEY PROJECT:
Seven month industrial project carried out at - Wockhardt Research Center, Aurangabad, from June 2008 to December 2008. Title of thesis - “ Evaluation of antidiabetic and antihyperlipidemic property of Cassia sophera in Wistar rats”.
- Research Guide : Dr. Yati Chugh ( Industrial), Dr. G.S. Chakraborthy (Institutional)
- The project involved –
- Induction of hyperlipidemia and diabetes by using high fat diet and treating the animals with the herbal drug.
- Retro orbital plexus method was used to withdraw the blood.
- The parameters like serum glucose, insulin, HDL, LDL, Triglycerides and cholesterol of animals were estimated using DADE BEAR Autoanalyzer.

OTHER INDUSTRIAL WORK:
- Worked in Drug Metabolism and Pharmacokinetics Department, Wockhardt Research Center, Aurangabad. Work Done –
- Withdrawal of animal blood sample and separation of serum.
- Extraction of the drug from the serum.
- Preparation of LCMS MS linearity.
- Worked in Safety Pharmacology Department, Wockhardt Research Center, Aurangabad.
Work Done –Blood Pressure Measurement in Wistar rats (Using Powerlab instrument)

ACADEMIC WORK:
- “The experimental evaluation of anti-inflammatory property of aceclofenac gel using a novel co-surfactant 'transcutol' in rats and mice” carried out as a minor research project during M. Pharm .1st year at NMIMS, Shirpur.
- “Formulation development and evaluation of tablets of leaf extract of Cassia sophera” carried out as a minor project in M. Pharm 2nd year at NMIMS, Shirpur.

PRESENTATION:
- Poster presented at - “ National seminar on hiy / aids : a global perspective”, arranged by J.L.Chaturvedi College of Pharmacy, Nagpur, 2nd & 3rd NOV. 2007
TITLE – “Nutraceuticals in HIV / AIDS (Review)”

SKILLS:
- Instruments Handled : Power lab, Plethysmometer, UV Spectrophotometer (PERKIN ELMER), HPLC (SHIMADZU), Autoanalyzer (DADE BERE), Dissolution Apparatus (Electrolab), Disintegration Apparatus (Electrolab)
- Animal (Wistar rats, Swiss mice) Handling, Withdrawal of blood samples, Serum sampling
- Preparation of LCMS linearity.
- Computer Operating: Microsoft Office 2003 & 2007, Internet.

AREAS OF INTEREST:
- Preclinical research
- Clinical research
- Drug Metabolism and Pharmacokinetics (DMPK)
- Formulation and Development

DECLARATION:
I hereby declare that the above mentioned information is authentic and true to the best of my knowledge.

Place:
Date: Rahul Rameshrao Metangale

[Guest]

BHUMIKA KAUSHIK
Email : bhumika_shrm AT yahoo.com ; bhumikashrm AT gmail.com
Looking for a position where challenges are a plenty and learning is a routine, where growth is limited only by performance.
Professional Profile
- Masters in Business Administration (MBA) in Human Resource Management (Major), Sales & Marketing (Minor) in 2004 from Lucknow University.
- Bachelor of Commerce (B.Com) from Meerut University.
- Having 1+ year of work experience in Human Resource Management.
- Worked with Accenture and worked for MICROSOFT India Pvt Ltd client.
- Worked with Kelly Services for GOOGLE India Pvt Ltd as a client for internal recruitments.
Area of Exposure
- Hiring procedures, Sourcing & Screening of candidates, coordinating interviews.
- Worked on Performance appraisal Management of employees
- Experience in computing monthly benefits.
- Searching candidates through various job portals.
- Coordinated orientations and exit interviews for part-time and temporary employees.
- Have good knowledge & experience in Admin activities, Event Management.
- Preparing MIS reports.
- Worked towards Increasing and developing sales.
- Maintaining relationship with clients.
- Acting as a contact between a company and its potential clients.
- Responsible for overall team performance.
Computer Proficiency
- Advanced knowledge on Microsoft Excel features like Formulas, Data Validations, Lookups (List), Pivot Table, Charts (Column/Pie), Data Reference across sheets.
- Worked on Microsoft Office and PowerPoint.
Organizational Experience
Accenture ( Microsoft as Client ) PMO
Kelly Services ( Google as Client) HR Recruiter
Academic Credentials
Year Degree University Percentage
July 2004 MBA Lucknow University 73.10
Mar 2004 M.Com (Corsp.) Meerut University 50.20
Mar 2002 B.Com Meerut University 54.50
Project Profile - Industrial Projects Undertaken
1. Worked with Accenture PMO (Project Management Office) team for Microsoft (May10-May 11) off role and on rolls...
Job Profile :
- Resource demand & supply management
- Consolidating demands for new resources in the database and submitting new demands based on the requirements for the project.
- Locking resources to the project/engagement as and when required using the Resource Management tool.
- Managing the supply pipeline - Identifying suitable bench resources by mapping their skill sets with the project requirements.
- Updating and sharing the Demand & Supply trackers with all the project managers which provide them in-depth information on resource and demand status.
- Tracking/Reporting & Monitoring the Resource Headcount within the engagement.
- Tracking/Reporting all resource roll off’s and roll on’s into the engagement.
- Driving the submission of time reports - Ensuring 100% compliance in submission of time reports.
- Preparing LPC (Loaded Payroll Cost) monthly reports and sharing the same with the project team which helps in cost-benefit analysis.
- Setting up interviews for internal resources with external clients as when required
- Collecting Forecasting reports from the respective PM’s and generating Reports.
- Updating VML Master Tracker on daily basis.
- Initiating H1B Visa for the resources.
- Reviewing Accruals and send the Campus report to Onsite on Monthly Basis.
2. Worked with KELLLY SERVICES as an HR RECRUITER.(March 10— May 10) on Cotract for three months
Job Profile :
- Provide end to end recruitment solution to our clients which include understand the Job Description, source right candidates form job portals and other social network site, by head hunting from other corporate, conduct telephonic interview, salary negotiation with client and candidates and last placement of candidates.
- Coordinate & Follow up with client for feedback with regards to placement of candidates as well as generate new requirements.
- Proficient in computer.
- Responsible for screening the candidate profiles according to the given requirement.
- Working experience on Permanent and Contract positions closures.
- Excellent time management and organization skills, highly dependable, enthusiastic motivator, and a strong team player.
PERSONAL OVERVIEWS
- Highly motivated & self driven
- Readiness to face challenges
- Effective communication skill
- Willingness to learn .
- A good communication and strong team player.
- Strong organizing capabilities & good at people skills.
- Decision making abilities & strong believer in work.
Interests & Activities
- Sports (Badminton& Bowling)
- College Fests
- Technical Fests