CURRICULUM VITAE

Phani Madala

E-mail: acy5sg@r.postjobfree.com Mobile: +91-998*******

+91-982*******

CAREER OBJECTIVE

More than 06 years of experience as a Clinical Research Associate (CRA) in Clinical Trial Monitoring and experienced in Drug Design and Drug Development.

PROFESSIONAL EXPERIENCE

Clinical Research Associate III

INC Research (a Kindle Company) July 2016 to till present

Clinical Research Associate 2

Quintiles Research India Private Limited April 2015 to July 2016

(Working for F. Hoffmann-La Roche)

Officer - Clinical Trials

NATCO Pharma Limited, Hyderabad May 2014 to March 2015.

Clinical Research Associate

NATCO Pharma Limited, Hyderabad March 2009 to April 2014.

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Build awareness of features and opportunities of study to site.

Collaborate and liaise with study team members for project execution support as appropriate.

Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conduct close-out visits.

Ensure subject safety and adverse event reporting to sponsor and IRB/IEC

Monitor the Updating of Trial Master File and Maintenance of site logs

Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines

Providing all the documents required by the investigator for Ethics Committee submissions and study initiation.

In-depth Knowledge on ICH-GCP guidelines, Schedule Y and FDA regulations.

ICF verification for GCP compliance

Monitor the CRF completion and corrections as per the source data

Monitoring the progress of the Clinical Trial with strict adherence to ICH-GCP

Perform Remote Monitoring as per the Trial Monitoring Plan

Have a sound knowledge on Electronic Data Capture, including Inform, Medidata Rave, Timaeus & Clinion.

Drug discovery and Development

Initiating and overseeing the progress of a Clinical trial

Preparation and reviewing the Protocols, ICF and Case report forms for Clinical Studies

Assisting in Protocol and ICF development and CRF design for Phase I, II & III trials in Oncology

Preclinical data reviewing for updating the Drug Development process

THERAPEUTIC EXPERIENCE

Having Experience in Therapeutic Areas such as Oncology, Hematology and Lymphoma.

Have worked on the Indications such as CML and Solid Tumors in Oncology

Participated in more than 07 studies and Performed more than 100 Monitoring visits in Oncology Trials

Participated in a Hematology trial for the Indication of MDS which has 02 sites and conducted more than 15 visits.

Phase of Study

Indication

No. of Sites & Patients

Phase-I (NCE)

CML

02 sites in 45 patients

Phase-II (NCE)

CML & Solid Tumors

10 sites & 50 patients

Phase-I (NCE)

Solid Tumors

02 sites in 30 patients

Phase-III

MDS

02 sites in 10 patients

Phase-II

Breast Cancer

04 sites in 25 patients

Phase-III

Breast Cancer

11 sites in 52 patients

Phase-IV

Breast Cancer

02 sites in 22 patients

EDUCATIONAL QUALIFICATIONS

Master’s degree in Biochemistry from M.V.R PG College affiliated to Andhra University (during 2006-2008).

Bachelor’s degree in Biochemistry from Sri Kavitha College affiliated to Kakatiya University (during 2003-2006).

Intermediate (Bi.p.c) from Board for Intermediate Education, A.P (during 2001-2003).

Secondary School Certificate from State Board for Secondary Education in 2001.

COMPUTER SKILLS

Proficiency in MS office, Windows, E mail and Internet applications

TRAININGS ATTENDED

Participated in Pharmacovigilance workshop at Cliniminds in September 2014.

Trained in Pharmacovigilance & Clinical Data Management at Heva Technologies, Chennai in 2014.

Participated in the “5th Annual Clinical Trials Summit 2014” held in Mumbai on June 10th 2014.

Workshop conducted by Indian Society of Clinical Research (ISCR) on “CLINICAL TRIAL REGULATIONS FOR INDIA” at Hyderabad on 17th December 2010.

Seminar on Clinical Research at Secunderabad.

Workshop conducted by Indian Society of Clinical Research (ISCR) on “Advanced Monitoring Skills” at Hyderabad in September 2011.

Oncology Clinical Research Fundamentals workshop in Mumbai during 03-04 December 2015.

Monitoring Fundamentals Application Workshop in Mumbai during 16-19 Feb 2016.

PERSONAL INFORMATION

Date of Birth : 19-08-1986

Gender : Male

Marital Status : Married

Languages Known : English, Hindi and Telugu.

(M. PHANI)

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