Bhanupriya Tummapalapriya.bhanu05@gmail.com+971- 55-7073092 / 55 - 4458537_________________________________________________________________________________________________________

CAREER OBJECTIVE:

To pursue a challenging career and be a part of progressive organization that gives me

scope to enhance my knowledge, skill and reach the pinnacle in the field with

determination, dedication and hard work.

EDUCATIONAL QUALIFICATION:

M. Pharmacy (Pharmaceutical analysis & quality assurance) from Nagarjuna

University 2012 with 83%.

B. Pharmacy from Nagarjuna University 2009 with 80%.

D. Pharmacy from Board of Technical Education 2006 with 77%.

WORK EXPERIENCE:

Worked in Piramal clinical research, Hyderabad as Executive client and project

manager since Aug 2014 to May 2015.

Worked in Global Data Business and Market Research, Hyderabad as senior

Researcher analyst {Clinical Trials} since Jul 2012 to Aug 2014.

Worked in the GVK Biosciences Pvt Ltd as a Clinical Research Associate from Dec

2009 to Dec 2010.

RESPONSIBILITIES WITH PIRAMAL CLINICAL RESEARCH:

Key Responsibilities:

Project management activities right from study initiation till completion of the study.

Conducting study start up meetings. (internal and external)

Serve as focal point in clinical research division for communication with clients and facilitate site initiation and monitoring visit for clients.

Attend and participate in teleconferences with Clients, audits, training programs.

Effectively communicate relevant project information, escalate issues to superiors for timely completion of the projects

Responsible for costing, estimating and planning projects.

Preparing Project Initiation documentation.

Maintaining and completing Project Key Performance Indicators.

Tracking activities against the detailed project plans.

Updating project plans to include agreed changes.

Monitoring actual expenditure figures against project budgets.

Organizing and facilitating Project Steering / Operating Committees meetings.

Business meetings and regular approach with clients.

RESPONSIBILITIES WITH GLOBALDATA:

Domain Applications:

A. Meta-analysis of Clinical Trials:

Retrieving the clinical trials from Clinical Trial Registries and

identification of the relevant information

Primary and Secondary Research especially for interpreting Clinical

Trials Results from Sources mostly including, but not limited to:

Clinical Trial Registries

Company Websites, Annual Reports

Internal and External Proprietary Databases

News Articles, Press Releases, Conferences

Scientific Journals and other Technical Literature

Management Assistance:

A. Distribution of Daily Tasks as well as tasks customized as per Client Queries

across the team

B. Maintaining Project completion Records and Trackers

C. Quality Check for Clinical Trial information

Technical Assistance:

A. Home Page designing for GlobalData's Pharma-eTrack Web Portal

considering Client point of view, as per the state-of-the-art technologies

B. Provided significant inputs during the building phase of GlobalData's

Preclinical Database Project as well as SAS Project team building.

RESPONSIBILITIES WITH GVK BIO:

As CRA

Study in charge, which includes Planning and presentation of clinical research study

information, supervision of study related activities and Clinical data review.

Execute the studies as per protocol, SOP’s, GCP and other Regulatory requirements.

Checking the correctness, completeness, authenticity and designing of the CRF’s.

Communication of Study Updates with Investigators, Sponsor and Project management.

Reporting of the adverse events and Serious Adverse Event to the Sponsor and IEC.

Co ordination with all concerned departments for proper planning & execution of

studies.

Co ordination and being responsible for the designing and preparation of Clinical Study

reports, and summary reports as per regulatory requirements.

Review of protocol, ICF, protocol training sheet, reports, study completion summary for

submission to IEC, docket.

AUDITS FACED:

Involved in USFDA, WHO and French audits successfully

completed.

TRAININGS UNDERWENT:

Underwent In-house training on ICH-GCP Conducted in GVK BIO Sciences Private Limited, Hyderabad.

TECHNICAL SKILLS:

Good Comprehension of FDA and CDISC guidelines, Good Clinical Practice (GCP), Good laboratory practice (GLP), International Conference of Harmonization (ICH) and other regulatory guidelines (NDA including an ISE and ISS).

Knowledge of clinical trials types, designs. Underwent Open Clinica 3.2 and SAS programming in a Clinical Background. Knowledge of ICF and IRB

Excellent interpersonal skills, Enthusiastic and highly motivated professional with proven skills in research project, presentation, prioritizing and managing

AREAS OF IINTEREST:

Client and project management Clinical Research and Clinical Trails Regulatory affairs

RESEARCH PROJECTS:

Project undertaken for M.Pharm : Have done project in GVK BIO on “Bioanalytical method development and validation

of Duloxetine hydrochloride in human plasma using LCMS/MS

List of publications

Published two research papers in Asian Journal of Pharmaceutical analysis and medicinal chemistry & International Journal of Science and Technology.

PERSONAL DETAILS:

Gender: Female

Date of Birth: 24-02-1987

Citizenship: India

Marital Status: Married

Languages known: English, Telugu, Hindi

DECLARATION: As far as I am concerned, the above-furnished details regarding me are true and correct to the best of my knowledge.

(Bhanupriya Tummapala)