Clinical Research Manager Resumes in India-Maharashtra-Pune: Sushma

Clinical Research Manager Resume

Contact Candidate

Name:

Sushma

Location:

India-Maharashtra-Pune

Experience:

5-10 yrs

Willing to Relocate:

Yes

Willing to Travel:

Yes

Most Recent Job Title:

Clinical Research Manager

Personal Website:

Objective:

To apply my knowledge in the field of clinical research and

administration by utilizing my skills and experience

Resume Text:

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Address:

S. No. 39/2, Matenagar, Road No.4,

Opp. Niramay Hospital,

Wadgaonsheri,

PUNE-411014.

Mobile No. 09860200022

Residence No. +91 - 020-27033649

Date of Birth : 03^rd October 1975

Languages Known : Telugu, English, Hindi, Marati

________________________________________________________________

OBJECTIVE :-

Ø To apply my knowledge in the field of clinical research and administration by utilizing my skills and experience

Ø Undertake responsibilities as a Manager and work with multi-disciplinary teams in organizing and conducting projects for its successful outcome.

EDUCATIONAL QUALIFICATIONS:

Ø M.Sc. (Environmental Science) Jul’ 1997 – Nov’ 1999

Kakatiya University, Warangal,

A.P. India.

Ø B.Sc. (Microbiology) Jul’ 1993 – Jun’ 1996

Osmania University, Hyderabad,

A.P. India.

Ø Schooling, (S.S.C. Board),

A.P. Secondary Board

TECHNICAL QUALIFICATIONS:

Ø Certificate in Computing,

IGNOU, Delhi.

Ø Typing speed – 60 words/min

TOTAL WORK EXPERIENCE (STARTING FROM PAST TO RECENT):

Worked in Ruby Hall Clinic (Multispecialty 550 bedded Hospital) , Pune for 4 years from August 2003 to December 2006 as a Clinical Research Associate/Study Coordinator /Trauma Unit Coordinator.

Responsibilities Included

§ Providing the feasibility information of PIs to pharmaceutical companies or CROs for the clinical trials

§ Knowing the protocol

§ Organizing the EC (Ethics Committee) meetings and fulfilling their requirements for the study to be initiated and getting the approvals of the trial studies

§ Screening the patients for drug trials of reputed organizations

§ Taking responsibility of enrolled patients by PI (Principal Investigator) and making sure that the Principal Investigator is conducting the study according to the protocol of the study

§ Taking informed consent form at the time of study from the enrolled subjects

§ Filling Case Report Form (have experience of filling eCRF also)

§ Reporting AEs (Adverse Events) and SAEs (Serious Adverse Events) to the regulatory authorities

§ Responsibility of drug storage, blood samples(plasma and serum), other biological (urine, faeces, CSF, Biopsy samples etc) and transporting them to the related laboratory

§ Well versed with IVRS (Interactive voice recognition system) operations and experience of online enrolling, randomizing etc of the subjects

§ Attending the investigator meetings

§ Filing all the trial-related documents regarding study start up and IRB correspondence

§ Maintaining Investigator Site Files with all the relevant documents

§ QA checking of the data made by doctors/hospitals during screening and keeping record of copy of Source Documents from the hospital file etc, organizing studies with full proof work plan and getting it executed

§ Supporting external QA audits

§ Complete follow up with the PI, other CRAs, QA, Ethical committee and regulatory affairs personnel

§ Destruction of the study bio medical waste according to the guidelines of the Bio Medical waste treatment available at the site with the help of concerned department professionals and providing them the certificate

§ Archival of the study documents according to GCP guidelines and regulatory authorities

Currently working for Quantum Ltd (Clinical Research Organization) as an Assistant Manager operations Study Coordinator from Jan 2007 to till date

Responsibilities

§ Knowing the protocol

§ Communicating with the PI, sponsor and with our Sr. Managers (CRO)

§ Organizing and preparing for the EC meetings, solving queries and doubts raised by IRB (institutional Review Board) members

§ Making sure that CRO has everything for central IRB submission

§ Investigational Medicinal Product (IMP) management

§ ENROLL SUBJECTS

§ Performing study assessment, Initiation, monitoring and close out visits of all the clinical trials conducting in various sites

§ Deciding budgets, milestones, summaries of the projects

§ Making monitoring plans and coordinating to ensure timely monitoring of the sites for GCP and SOP compliance with CRAs

§ Training and guiding the Clinical Research Associates (CRAs) appointed for the administration of the clinical trials at the sites and auditing the same for the perfection

§ Gathering the information regarding regulatory authorities

§ Reviewing the FDA/ICH/GCP guidelines and participating in the investigator’s meeting and conducting awareness program of the same for our team members

§ Reporting to my Seniors - related studies, their progress and progress of the team

§ Preparing Study Plans, Project out lines related to duration of the study

§ QA checking of the data generated by CRAs

§ Taking responsible for the management of all sites conducting trials and all CRAs progress.

§ Proficient in MS-Project

§ Well conversant with the other aspects of clinical trial like –

Ø Regulatory affairs, Site Management etc

Additional Training : -

Attended the workshop of Quality Control in clinical trails in Pune University from Ruby Hall Clinic
Attended for the below-mentioned study-related investigator’s meeting in Bombay (ICH-GCP guidelines, protocol discussion, CRF etc.) from Ruby Hall Clinic
Attended the ICH-GCP guidelines training program in Pune on 2nd January 2006 sponsored by Sanofi-Aventis from Ruby Hall Clinic.
Undergone ICH-GCP guidelines, SOPs training in the currently working organization.
Currently pursuing a Certificate Course in Clinical Research and Clinical Data Management from Pune University (Duration – 6 months)

Projects Worked for :-

Had successfully worked for the drug trail studies as a Clinical Research Associate/Coordinator in Ruby Hall Clinic for the following therapeutic areas

End Stage Renal Disease (Dr. Abhay Huprikar – Nephrology – Principal Investigator )
Severe Sepsis (Dr. Prachee Sathe – General Medicine – Principal Investigator)
Deep Venous Thrombosis (Dr. Prachee Sathe – General Medicine – Principal Investigator)

Had also worked for Severe Sepsis Survey In the Intensive Care Unit of Ruby hall Clinic under Dr. Prachee Sathe

Projects Worked for in the Current Company

Ø Phase III trials in Oncology

Ø Phase III trials in Arthritis, UTI, Sinusistis

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