Clinical Trial Research

Azha Afreen **********@******.***

Riyadh, KSA +966-*********

www.linkedin.com/in/azha-afreen-8b377a32

Career Summary

Clinical data manager with 5+ years of experience in clinical research ICH GCP. With extensive experience managing all aspects of clinical trials, Handling daily activities, writing reports and maintaining clinical trial documents. Committed to working closely with the practitioners, patients, families and other professionals for well-roundedmedical care. Technical Expertise

GCP-Trained: Successfully Completed GCP training at the NIH CLRN network. Experience working with Inform 4.6, Open clinica, Enable, Oracle database.

Laboratory: In-depth Knowledge of SEM, TEM,Cell culture, MTT Assays, DCFHDA assays and ELISA. Analysis of Nanoparticles and Chemical compounds. Acid-Base titrations.

Pharmacy: Pharmacy dispensing, checking of Prescriptions, storage management, stocking and temperature chain management for vaccines and thermo labile Medications.

IT Skills: Microsoft Office, Power point and Proficient Internet research-Knowledge database and Desktop management skills, InForm, Clinical Trial and Medidata Rave EDUCATION

Masters of Science, Clinical Research, 2010

Cranfield University, Bedfordshire, UK

Diploma, Clinical Trials Management, 2009

Institute of Clinical Research, Hyderabad, India

Diploma, Clinical Pharmacy, 2008

Medwin Institute of Medical Sciences, Hyderabad, India

Bachelors, Pharmacy 2007

Jawaharlal Nehru Technological University

Work Experience

Pingme New York City, New York

QA Test Lead May 2017 - Present

Responsibilities:

Identified Test scenarios, estimated test efforts and created test plans

Created key metrics and audit processes to ensure established goals were met

Developed testing reports, reducing data to key insights that helped increase key efficiency by 31%

Assisted the QA team with the creation of the regression test suite

Reduced IT workload by 20% through the improvement of QA processes

Contributed to the early release of 20+ premium features that provided secure experiences for 3000 global users

Mentored junior QA team members in Agile SDLC techniques improving their productivity by 70%

Tested various software application features by modifying its configuration

Designed a program that simulated the workflow of 1519 users for accessing data and provided helpful recommendations to leadership

Collaborated with 6 software development engineers to understand the features and architecture of multiple web-based applications to perform testing with 100% efficiency.

Created test cases to implement new functionalities and review requirements Syncorp Hyderabad, India

Clinical Data Manager April 2015- Feb 2017

Responsibilities

Maintenance of study regulator documents, including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs

Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures

Expertly conducted full range of patient and protocol assessments, including safety and efficacy, vital signs and EKGs.

Active contributor in investigator/sponsor and coordinator meetings, sharing valuable study data and insight as requested.

Communicated professionally to internal and external study teams the performance of recruitment tactics.

Increased study engagement both with patients and site staff along with support study compliance requirements to meet sponsor goals.

Oxford University Hospitals NHS Trust- Churchill Hospital Oxford, UK Late Phase haematology team-Data Manager Sept 2012- April 2013

Extract, interpret and record information from patient notes as required by the established study protocol on paper forms, in-house electronic CRF databases or web-based interfaces

Ensuring accuracy, completeness, consistency and compliance with study guidelines of source documents, CRFs, and related documents as an essential part of the research effort

Act as first port of call for data query resolution for internal investigators and external sponsors

Resolving discrepancies by referring to and interpreting the trial protocols whenever required by trial management monitors or investigators

Liaise with the consultant principal investigator (PI) or delegated doctor, allocated research nurse, and sponsor company monitor for resolving complicated queries.

Design and Implementation of Data Capture Forms (DCFs)

Liaise with data managers, clinicians and nurses to produce forms for use during patient interviews and assessments

Design user friendly and unambiguous DCFs, using word processing or spreadsheet applications as appropriate, to capture the requirements of the protocols

Reporting of Data: Prepare and submit progress reports to investigators and sponsors

Actively participate in trial set up meetings comprising clinicians, nurses, sponsor representatives and data managers

Participate in regular review of, and decision making with regard to, data management procedures

Participate in and assist the development and implementation of Unit wide policies and procedures (SOPs) to ensure the efficient operation of the Assigned trials

Completion of Case Report Forms (CRFs) for clinical trials

Maintain up to date knowledge of ICH GCP and European Legislative Standard as well as departmental SOPs

University Of Birmingham Birmingham, UK

Data Manager Oct 2011- Sept 2012

Updated clinical trial Database and IRAS Database to be submitted to MHRA

Prepared Site Specific Information Forms, Pharmacy Manuals and files, Site Files, stationary files and screening files by following specific sites to gather essential data

Worked closely with the principal investigator, research nurses and health care professionals to maintain the trial documents

Generated queries and participated actively in group meeting and Ethical review meetings.

Acted as a First port of contact for Query resolution

Managed the clinical trial process for the smooth functioning of the trial University Of Birmingham Birmingham, UK

VoluntaryWork July 2011- Dec 2011

Ensured and established study protocols were implemented and followed according toICH- GCP

Reviewed clinical trial data and all databases for completeness, accuracy and consistency

Worked with InForm, Clinical Trial and Medidata Rave to manage study data

Actively particiapted in the review of cliniial research documents (example: protocols,case- report forms, reports and statistical analysis plans)

Assist in reconciling AE/SAE data in safety database and other data management databases.

Prepared Site Specific Documents, SOP'S, Protocol amendments and to shadow Clinical trial co-ordinators in day to day trial work

ACADEMIC PROJECTS

Masters in Clinical Research –Pilot Study” Identification Of Hazardous Engineered Nanopaarticles Using human cell lines”, Cranfield, UK

Successfully completed project sponsored by Cranfield Nano (i.e) Pilot study

Identified hazardous nanoparticles (NPs) through their toxic effect on human cells

A549 carcinoma lung epithelial cells were used to mimic route of exposure via inhalation

Studied Silica and polymer NPs for toxicity potential

Analysed physiochemical properties by hydrodynamic light scattering assay, transmission electron microscopy and scanning electron microscopy

Investigated cellular toxicity endpoints, including cell viability, morphology and oxidative stress after NP exposure

Research reports identified the safe and effective dose of promising polymers used for drug delivery

Suggested research to assess the health risk of human exposure to different engineered Nano particles

PUBLICATION

Pilot Study of Identifying Hazardous Engineered Nanoparticles Using Human Cell Excel Journal of Engineering Technology and Management Science, 2019 PERSONAL INFORMATION:

Name: Azha Afreen

DoB: August 27th, 1986

Nationality: Indian

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