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<pre>Array ( [var] => cut_url ) </pre> Resume for sneha P. for Medical Doctor / Healthcare Professional / Biotechnology & Pharmaceuticals in Hyderabad-Deccan, India. Search More Resumes for Medical Doctor / Healthcare Professional on #AN8AWIXA8

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Resume for sneha P. for Medical Doctor / Healthcare Professional / Biotechnology & Pharmaceuticals in Hyderabad-Deccan, India

Occupation: Medical Doctor / Healthcare Professional Industry: Biotechnology & Pharmaceuticals
Country: India City: Hyderabad-Deccan
State: Andhra Pradesh ZIP: 500035

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I foresee myself as a professional in a research oriented organization in the position of trust and
responsibility. To me an ideal environment is that which provides scope to grow and horizontally
widen my expertise and knowledge, this I perceive through hard work, sincerity and zeal to excel.
. Offering years of experience in the field of Clinical Research and clinical data
. A quick learner with positive attitude, honest and ability to work in a team environment
and can lead a study team as well.
. Knowledge of SOPs/guidelines, ICHGCP and other applicable local and international
. Have been involved in projects till date and have facilitated successful study lock for
studies and I have served as study point of contact for and contributed as a main resource
for others.
. Have knowledge on EDC Project life Cycle and exposed to activities related to study start
Validation of checks and study conduct and close out for GlobalMulticentric studies
from Phase I to Phase III.
. Handling of Data discrepancy resolution and External data Reconciliations including
SAEs and looking after data cleaning.
. Handling of relevant study teleconference with the Sponsor staff to communicate and
addressing study related issues or concern.
. Experienced and trained in different EDC tools i.e., RAVE, INFORM and DATA LABS
and SQL.
. Handling of relevant study related documentation and training of site personnel on various
protocol prerequisites.
Therapeutic Area Experience:
Endocrinology/Metabolic Disorders: Study
Dermatology: Study
Neurology: Studies
Ophthalmology: Study
Oncology: Study
WORK EXPERIENCE: Clinical Data AnalystI, PAREXEL International, Hyderabad
October to May : As Clinical Data AnalystI, essential function is to perform all
clinical data cleaning activities on assigned projects, commensurate to their project role, taking on
specific responsibility for multiple tasks or single projects. This includes the requirement to have
an understanding data validation, generation and integration of queries, coding of clinical data,
reconciliation of safety and electronic data. Work to the appropriate standards of quality and
Key responsibilities:
. Through understanding of the all the study specific documents such as protocol, Case
Report Forms CRFs, data cleaning guidelines, data validation guidelines and the
timelines of study deliverables.
. Responsible for handling discrepancies Query resolution and Query integration in
Database as per protocol. Perform external checks to handle manual discrepancies and
action the same. If required liaise with rd party vendors to clean electronic data for
external data reconciliations.
. Application of selfevident corrections according to relevant guidelines and identification
of protocol violations and reporting them.
. Perform ongoing and final consistency checks, review protocol deviation handling
document and data listings to ensure that all data have been handled appropriately
according to the DMP.
. To freeze, lock data and perform Functional QC as appropriate in time for statistical
review blinded interim quality review, interim and final database lock. Handled Dataset
review according to given guidelines and procedures.
. Conduct of User Acceptance Testing UAT of EDC systems to ensure screening design
matches protocol & edits are programmed & operating as intended & escalate the errors
identified to the CDM study manager.
. Take responsibility for specific tasks on projects, or acts as the main CDA contact on
individual projects and training of study team members on selected tasks. And also
maintenance of local study files in case of global study.
. Attend relevant study teleconference with the Sponsor staff to communicate and address
any study related issues or concerns.
. Communication of Data Trends with the onsite study team and the clinical site
coordinators on the progress of the study.
. Review and resolve data discrepancies identified by the system or through manual checks as
identified in the data editing guidelines.
. Successfully delivered and locked critical studies.
. Received sponsor appreciation for meeting deliverables and meeting study timelines.
. Received best employee award.
Clinical Research Associate Trainee at CATO ResearchNEULAND LABORATORIES,
Hyderabad to .
Key responsibilities:
. Involved in, inhouse Site identification.
. Training of Site staff on study specificities such as CRF filling, source data verification
procedures handling, addressing queries/responses raised by data management.
. Handling of relevant study related documentation and training of site personnel on
various protocol prerequisites.
. Have been involved with projects and successfully initiated site enrollment.
. Assisting a team for literature search, involved in setting up a site monitoring office.
. To study the infrastructure required for clinical trial sites in Hyderabad Internship
. Masters in Clinical Research , from CRANFIELD UNIVERSITY in
collaboration with Institute of Clinical Research India ICRI, Bangalore.
. Post Graduate diploma in Clinical Research Management PGDCRM , from
Institute of Clinical Research India, Bangalore.
. Successfully completed Bachelors of Science in Microbiology from Avanthi
Degree College Affiliated to Osmania University, Hyderabad.
. Intermediate from Board of Intermediate Andhra Pradesh
. SSC from Board of Secondary Education Andhra Pradesh .
. Attended short term training in Clinical Research sponsored and certified by DBTDept. of
Biotechnology India at NIMSNizam’s Institute Of Medical Sciences, Hyderabad from
th th April .
. Attended “ICBIO ” International Conference on Clinical Research and Health Care
organized by ABLE association and ICBIO Innovation Centre for Biosciences at IISc
Campus in Bangalore, from th – th March .
. Attended HUMAN GENOME MEETING organized by HUGOHuman Genome Organization in
Hyderabad, from th th September .
. Attended “BIOMERITS ’’ conference organized at SRM University campus in Chennai, from rd
th February .
. Active member of “IDHYA”a non profitable organization spreading environmental
GENDER : Female
STRENGTHS : Hard working, Flexible, Punctual, Determined& Sincere.
LANGUAGES KNOWN : English & Indian Languages Hindi and Telugu.

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