Clinical Research and Pharmacist

Mahesh Vijay Palav

New Ganjawalla Bldg, **/B, *nd Floor, Tardeo, Mumbai, India -400 034

●● 022-********, +91-900*******●● ******.*****@*****.*** ●●

Canada Express Entry Application: E000556097

PROFESSIONAL OUTLINE

Highly dedicated and self-motivated and multi-skilled pharmacist professional with management experience and expertise in conduct and review of clinical trials with an overall experience of 7.5 years in Clinical Research with expertise in Clinical Data Management Setup, Conduct, Closeout activities and HealthCare. Have an experience in working in different therapeutic areas like Oncology, Rheumatoid Arthritis, Cardio Vascular System, Respiratory System and Neurology etc. I am able to handle the entire spectrum of pharmaceuticals with the emphasis on delivering my high quality services.

Aspiring to expand my experience as a pharmacist in the prestigious organization where I can utilize my active experience and skills for delivering promising work. I would like to offer my expertise for performing in professional environment.

ACADEMIC CREDENTIALS

Master of Business Administration (Operations) – Master’s Degree Pursuing

Sikkim Manipal University,(Mumbai),India

Bachelor of Pharmacy– Bachelor’s Degree April 2008

M.E.S College of Pharmacy, Pune University,Pune,India

Diploma in Pharmacy – Diploma April 2004

M.E.T Institute of Pharmacy, Mumbai University,Mumbai,India

PROFESSIONAL CHRONOLOGY

Tata Consultancy Private Limited - (Mumbai), India September 2015 till date

Senior Process Associate

Main Duties:

1.Providing general data management support to the project team, sponsor and external vendors, as needed.

2.Responsible for the development of electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.

3.Responsible for reviewing of programming and ongoing maintenance of the clinical database.

4.Responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).

5.Responsible in the development of eCRF completion guidelines and other training material required to train site users and monitors.

6.Conducting training for site users/monitors on the clinical database.

7.Developing data transfer agreements and specifications with vendors providing external data (e.g. laboratory results).

8.Conducting reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed).

9.Providing support to study team in the development of external systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and EDC are documented and tested appropriately.

10.Responsible for the development of the data management plan (DMP), and other clinical data management related documentation.

11.Responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/close.

12.Coordinating with Coding team for coding of medical terms in the clinical database, as required.

13.Generating data listings and reports needed for data review by the project manager (or other study team members) in preparation for database close/lock

14.Monitoring study status (e.g. enrolment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.

15.Ensuring that data management documentation is complete and up-to-date in the trial master file (TMF).

16.Activating/de-activating new users in the clinical database in response to requests from the project manager and maintain records of such requests.

17.Responding to users requiring assistance with the EDC system.

18.Responsible for archiving of the clinical database and related documents.

19.Participating in the definition, writing and updating of data management SOPs

20.For any studies where any of the above activities have been outsourced to an external service provider: Oversee/manage the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements. Ensure that their work is done in accordance with effective work orders and TCS SOPs (if applicable).

Cognizant Technology Solutions - (Mumbai), India July 2012 July 2015

Data Analyst

Main Duties:

1.Perform assigned data management activities with focus on quality and timelines as per the SWP’s and trial specific documentation.

2.Co-ordinate with Managers to track and report status and progress of data management for allocated trials and pro-active to ensure smooth and successful timely looking into databases.

3.Co-ordinate with Managers to ensure that assigned trial is managed efficiently with high quality.

4.Support UAT according to Validation Plan of all applicable Data Management Systems and provide inputs to ensure quality and consistency of documentation and eCRFs.

5.Perform ongoing data review and cleaning activities for assigned trial.

6.Support Quality control checks for the trial.

7.Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements.

8.Participate in knowledge sharing sessions as and when applicable.

9.Adherence to SWP’s and SOP’s.

10.Escalate issues and trends in database in a timely manner with Manager.

11.Create training material and impart training as required.

12.Ensure completeness and correctness of training records.

13.Efficient collaboration with team to ensure high quality timely deliverables.

14.Ensure adherence to Quality and Productivity targets.

15.Participate in Root Cause Analysis as required.

16.Contribute to Process improvements.

17.Adhere to Communication and Risk/issue escalation pathways.

ARM Chemists & Provision Pvt Ltd - (Mumbai), India May 2008 July 2012

Pharmacist May 2008 - May 2010

Senior Pharmacist May 2012 - July 2012

Main Duties:

1.Observe high standards of Professional skill in dispensing medicines as per prescriptions for proper dosage.

2.Ensuring proper distribution and storage of vaccines, serums, biological and other drugs and pharmaceuticals.

3.Dispensing prescribed drugs to customers as well as other people in health care industry and guide them on indications, contra-indications, adverse effects, drug interactions and dosage.

4.Periodical stock checking and updating inventory by ordering drugs. Check expiry of medicines and returning them to pharmaceutical suppliers.

5.Maintaining record of the customer’s medication profile including narcotics, poison, and controlled drugs. Also update the inventory of the same.

6.Supervising and coordinating the task of the other pharmacy staffs like the pharmacist, pharmacy technician, pharmacy assistants at the dispensing counter.

7.Advise patients on selection and use of non-prescription medication. Furnish information regarding medicines to doctors and healthcare professionals.

8.Billing and collecting cash for the dispensed medicines.

9.To maintain drug records as per Drug Act.

10.Mentoring junior staff and work allotment to them.

AREAS OF EXPERTISE

Technical Proficiency

MS Office, Oracle Clinical 4.5.3, OC-RDC Interface, J-Review, Rave.

Job Skills

1.Strong communication, analytical, problem solving, and decision making skills to effectively uncover and resolve complex issues.

2.Keeping up to date with developments in the pharmaceutical industry.

3.Possess strong knowledge of personal care & excellent hygiene skills.

4.Presenting a professional image appropriate to the working environment.

5.Adhering to all the Healthcare Trusts policies guidelines and procedures.

6.Dedication and hard work towards achieving the objectives and goals.

7.Ready to imbibe new concepts and keen to take research challenges.

8.Capable of managing any assigned task.

9.An understanding of the concept of confidentiality.

ESPECIAL ATTAINMENTS

Organizational Feats

1.Awarded with Wikipedia of the Month in February 2015.

2.Awarded with Star Team of the Month in December 2014.

3.Awarded with highest performance rating for financial year 2013.

4.Awarded with certification for Outstanding Performance, Productivity and Dedicated services in February 2013.

5.Awarded with certification for Outstanding Delivery Focus/Collaboration/ Excellence Displayed in September 2013.

REFERENCES AVAILABLE UPON REQUEST

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