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Clinical Research Project Manager

Location:
Ahmedabad, Gujarat, India
Posted:
March 08, 2019

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Resume:

RESUME

Saurabh Satishchandra Patel

E mail: ac8puz@r.postjobfree.com

Phone : (M) +91-917*******

Page 1 of 5

OBJECTIVE

A responsible and equally challenging position that allows exploring decision areas of clinical research and drug development with my capabilities, skills and sense of dedication towards the role honors, hav- ing an aim of progressing support to organization growth.

PROFESSIONAL SUMMARY

I have almost 8.4 years of experience in Clinical Research Industry includes project coordination, Medical Writing & Project Management.

Currently associated with Cliantha Research Limited, Ahmadabad as an Executive in Global Pro- ject Management.

I am familiar with ICH-GCP, Different regulatory and SOPs of BA/BE Study

I have also work in different dosage form such as Orally, Inhalation, Parenteral BE Study.

I have also work in Phase I and Glucose clamp study.

CAREER EXPERIENCE

Cliantha Research Ltd., Ahmedabad (July 2018 to till date): Designation: Executive- Global Project Management

Builds effective customer relationships with all functional areas within Cliantha Research and pro- vides updates and reports to internal and external project teams. Responsible for the project plan- ning, coordination and tracking of all activities related to the project milestones.

Responsible for investigating and completing required documentation for application to Drugs Controller General of India (DCGI) to ensure appropriate approvals are in place before execu- tion of study.

To issue client code and protocol / project number to prepare protocol.

Prepare project management documentation for sponsor identification and/or approval.

Attend teleconferences as scheduled for projects and ensure effective communication of project

/activities.

Demonstrates well-developed project management skills by utilizing the relevant databases, project management methodologies and processes to assist in planning, coordinating and moni- toring of all projects.

Participates in on-going educational activities to enhance own knowledge level as well as that of other team members.

RESUME

Saurabh Satishchandra Patel

E mail: ac8puz@r.postjobfree.com

Phone : (M) +91-917*******

Page 2 of 5

Cliantha Research Ltd., Ahmedabad (December 2016 to July 2018): Designation: Team Leader -Medical Writing (Sr. Research Associate)

Handling a team medical writer

Looking for the daily project activities of the medical writers

Meeting and coordinating with the sponsor for their project status and protocol status

Coordination with study personnel and other departments for protocol related issues for finalization of protocol

Coordination with IEC Coordinator for the submitted project, vendor audit, IEC visit to CRO etc.

Coordinate with Dietician for specific diet plan required for the some specific molecules.

Approval of protocols from Ethics committee in consultation with Principal Investigator and Sponsor.

Responsible for updating the protocol related concerns to investigator(s), sponsor and IEC

Preparation and revision of related SOPs.

Conforms to training schedule for own position and maintains awareness of SOPs contents accord- ing to company requirements

Involve in preparation of bio-similar PK-PD protocols, its requirements. Cliantha Research Ltd., Ahmedabad (Aug 2013 – December 2016): Designation: Sr. Research Associate (Medical Writing) Job Responsibilities:

Responsible for designing and preparation of Protocol, Case report form, Informed consent form and other protocol related documents in consultation with Group-In charge and Investiga- tors

Involve in the communication with internal departments (Statistical, Analytical) for preparation of Protocol.

Coordinate with the sponsor representative for resolving the protocol related queries.

Involve in the coordination with IEC co-ordinator for arranging the IEC meeting and approval of trial documents.

In absence of group leader, handling the team members and also resolve their queries during the protocol preparation.

RESUME

Saurabh Satishchandra Patel

E mail: ac8puz@r.postjobfree.com

Phone : (M) +91-917*******

Page 3 of 5

Nashik Biotech Clamp Unit, Nashik (Wockhardt Ltd.) (June 2012 – Aug 2013): Designation: Research Associate-I

Job Responsibilities:

My primary responsibility is the development of center as per the Glucose clamp study requirements along with the centre head.

Along with that I was involve in the visiting of diabetologist clinics around the Nashik area for the development of Diabetic patient database will going to use for conducting clamp study.

Involved in the designing and set up of unit to conduct the clamp study.

Involved in the ICU equipments installation required for the clamp study.

Perform telephonic coordination with the physician’s activities in order to obtain patient status in- formation.

Preparation of Trial related technical documents like, SOPs, Protocol, ICF, CRF, Laboratory Manu- al etc.

Preparation and maintenance of Project Master File.

Involve in providing the glucose clamp study related, SOP related, documentation related training to staff.

Veeda Clinical Research Pvt Ltd (May 2010 – June 2012): Designation: Project Coordinator (Jr. Research Associate) Job Responsibilities:

Coordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investiga- tor (CI) for

Preparation of the study protocol, CRFs and other working documents.

Prepare Informed Consent Documents (ICD) in English and coordinate for translation into local language(s) and it’s back translation into English, if applicable.

Prepare a dossier for submission to the regulatory and Independent Ethics Committee (IEC).

No Objection Certificate (NOC) from regulatory authority, IEC approval for study and IP avail- ability at site

Coordinate with the pharmacist and PM for Procurement, Handling, Storage, Dispensing (as per the randomization list), Accountability and Retention / Disposal / Retrieval of investigational products (IP).

Coordinate with the Principal Investigator / Project Manager for planning of study schedule.

Prepare Trial master file as per the SOP or Sponsor’s requirement.

Prepare the protocol summary for the protocol training.

Ensure that the protocol training is provided to the concerned study personnel, before the start of study related activities.

Coordinate with screening team for subject recruitment and screening. RESUME

Saurabh Satishchandra Patel

E mail: ac8puz@r.postjobfree.com

Phone : (M) +91-917*******

Page 4 of 5

Coordinate with Dietician to ensure that the meal menu is prepared as per protocol requirements and submitted to caterer well in advance.

Ensure that all the volunteers reported for ICD presentation are fit for participation in the study as per the respective protocol.

Coordinate with clinical staff for admission, discharge, Meal distribution, dosing/dosing super- vision and monitoring the subjects during study for restriction compliance.

Ensure that the biological samples are collected, processed, stored and transferred as mentioned in the protocol.

Ensure that the adverse event/serious adverse event reported during the study are adequately handled.

Monitor the study to ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and in house Standard Oper- ating Procedures (SOP).

Collect and review the raw data from group leaders (e.g. Nurse, Phlebotomist, CRP etc) and handover those to CQMs for their review and send to QA for retrospective audit.

Coordinate with the CQM and QA for audit reports and compilation.

Coordinate with Report writer and Project Manager for preparation of the final report

Ensure all the study documents are available as per the TMF checklist for audit.

SPECIAL PROJECTS HANDLED:

1. Work as Glucose Clamp Scientist for 32 hours (Long acting insulin) Euglycemic Glucose Clamp study to measure the Insulin action on healthy human subjects at Veeda Clinical Re- search Pvt. Ltd., Ahmedabad.

2. Work as Project Coordinator & Glucose Clamp Scientist for 08 hours Clamp study on the car- dio-metabolic patients (Phase-2A trial) at Veeda Clinical Research Pvt. Ltd., Ahmedabad.

PERSONL SKILLS

Knowledge of ICH-GCP

Knowledge of Computer (MS word, excel, power point) & Internet.

Excellent problem solving capabilities and organizational skills

Ability to prioritize and be adaptable to changes in work duties, responsibilities and requirements

TRAININGS & WORKSHOPS

Involve in the Observational Training Program in Glucose Clamp trial Implementation as well as of clamp procedure along with diabetes management conducted at “BRIGHHARMA and WOMENS Hospital, Bos- ton, USA” for 05 Days.

Attended a various GCP, ACLS/BLS training conducted at Veeda Clinical research Pvt. Ltd., Ahmedabad. RESUME

Saurabh Satishchandra Patel

E mail: ac8puz@r.postjobfree.com

Phone : (M) +91-917*******

Page 5 of 5

Annual GCP training at Cliantha Research Limited.

AREA of INTEREST:

Project Management

Business Development

Medical Writing

ACADEMIC QUALIFICATIONS

PGDCR (Clinical Research) – Xcellon Institute, Ahmedabad 65.5 % 2009 - 2010 B. Pharm – Saurashtra University, Junagadh, Gujarat 65.5 % 2005 – 2009

PERSONAL DETAILS

Name : Mr. Saurabh Satishchandra Patel

Date of Birth : 28.08.1988

Address :

D-302, Arjun Grace, B/H Naranpura Telephone Exchange, near Swaminarayan Sanskar Dham, Naranpura, Ahmedabad-380065 Languages Known : English, Hindi and Gujarati

References : If required.

Place: Ahmedabad, Gujarat, INDIA



Contact this candidate