Ravi Chalana E-Mail: ravichalana@gmail.

com Contact: +91 9624741416

Seeking middle level assignments as a Clinical Research Associate/Manager in an organisation of
high repute

Preferred Location: Anywhere in India

Professional Preface

A dynamic professional with more than 11 years of experience in Research & Development, Quality Assurance,
Laboratory Operations and Documentation in the Clinical Research Industry. Lastly worked with Sun
Pharmaceutical Industries LTD. (SPIL), Vadodara in Clinical Research Department (CPU) as Clinical
Research Manager.

Proficiency in scientific writing and documentation(SOP preparation, Protocol Preparation etc) and hands on experience
on computer software such as PowerPoint, Excel, MS-Office Applications, Statistical Software, Internet and other data
acquisition system software. Dealt in conducting toxicity testing, development, formulation and QC of parenterals. Well
versed with Emergency Instruments (Defibrillator, Nebuliser, BPL-Ingenta Bedside monitor suction apparatus,
Lyrangoscope, ECG, etc.).

Conversant with sample transfer from the site. Sound knowledge and experience in implementation of various quality
standards. Proficient in the implementation techniques for improving the operational efficiency and achieving cost
savings. An effective communicator with excellent relationship management skills and strong analytical, problem solving
& organisational abilities.

Areas of Expertise

Research & Development

 Preparing SOPs and protocols (Clinic Inputs).
 Conducting clinical trials (Many Phase I studies and many other pharmacodynamic studies etc.) and involving the
preparation of clinical trial formats/CSR (in NuLEAP/ LIAS or transcribing in it and verifying it)
 Maintaining the Pharmacy of Sun Pharma’s CPU (Facing Audits, Maintaining Accountability of Medicines, Filling
Respective Logs, and Dispensation, Receiving the drug, communicating with the Sponsor for regarding Pharmacy
etc.)

Quality Assurance
 Conducting Periodic inspections of The Overall System, Pharmacy (Drug Store), Emergency, Catering to the
subjects, Archiving, Study specific etc, Infection Control committee etc) to ensure the compliance of the Protocol
and SOPs.

Laboratory Operations
 Arranging periodic calibration of test equipment in the Facility either internally or by adequately qualified personnel
/ agencies in coordination with Maintenance & Materials Department.

Documentation
 Maintaining and peer-review documentation such as SOPs, CRFs, Various logbooks, training records, etc.
 Ensuring compliance of various quality measures (SOPs) by maintaining requisite documentation / records.
 Preparing daily & periodic reports for information, compliance & corrective action.

Employment Scan

TENURE ORGANISATION DESIGNATION

Aug’16-Aug’19 Sun Pharma (SPIL), Vadodara Manager
in Clinical Pharmacology Unit (CPU)
Apr’15-Jul’16 Sun Pharma (SPIL), CPU Research Executive
Apr’12 -Mar’15 Sun Pharma (SPIL), CPU Research Officer
Jan’08-Mar’12 Sun Pharma (SPIL), CPU Research Assistant
Nov’07-Jan’08 Bioinnovat Research Services Pvt. Ltd., New Delhi CR Executive
JAN’06-Aug’07 Various colleges in Punjab and Haryana Lecturer in Pharmacology
Training during Venus Remedies Ltd., Panchkula Trainee
B.Pharm IIIrd Year
 Key Deliverables

 Monitoring and coordinating Phase 1 studies, bioequivalence and Pharmacodynamic studies (Nasal spray,
ophthalmic, DPI, QTc Prolongation etc) from screening to study close out.
 Making and reviewing CRFs, preparing SOPs, Giving the vital inputs in protocol Preparation, Preparing clinical
reports, sample processing, AE follow up, submission of documents to respective departments, sample transfer,
ICF Explanation etc.
 Maintaining the:-
o Pharmacy of Sun Pharma’s CPU (Maintaining accountability of medicines, filling respective logs,
dispensing, receiving the drug, communicating with the sponsor for drug related problems etc.)
o Emergency Services of Sun Pharma’s CPU (Accountability of Emergency Medicines, Maintaining
Respective Log Books, Routine Calibration of Instruments and Data Logger Channels ).
o Infection Control Committee (ensuring compliance of fogging of wards, preparation of various solutions
and reagents, BMW management etc. )

Noteworthy Accomplishments

 Faced many successful audits (System and Pharmacy) by the FDA, ANVISA ,DCGI, MCC, MoH, EMA etc.

Research Projects Envisaged

 Accomplished many Bioequivalence studies and Pharmacodynamic studies (Nasal spray, ophthalmic, DPI, QTc
Prolongation etc) for Sun Pharma’s CPU, Vadodara.
 Pharmacological screening and evaluation of Thieno - Pyrimidine Analogues for Anti-Inflammatory activity (M.Pharm
Thesis).
 Anti-inflammatory and analgesic activity of EXCLzyme TM “a Project funded by Raj Biotech, Pune.”

Other Accolades

 Participated in Pre-RD parade camp organized by NSS at St. John College, Agra.
 Took part in various elocution, debate and group discussion competitions at University level.
 Organised various blood donation camps at University and College levels.
 Worked for various inspections carried out by FDA, DCGI, PCI, AICTE, CPCSEA and various other universities
inspections at Pharmacy colleges.

Scholastics

Certificate Course in Clinical Research & Clinical Data Management (CRCDM)

University of Pune in 2007. Obtained O grade with First class.

M. Pharmacy (Pharmacology)
Poona College of Pharmacy, Pune in 2005. Secured 67% marks.

B. Pharmacy
Guru Jambheshwar University, Hisar in 2003. Secured 62.73% marks.

Highlights:-
 Qualified GATE 2003 with 91.06 percentile.
 Recipient of Research fellowship from AICTE, New Delhi, for Postgraduate studies.

Personal Portfolio

Date of Birth: 8th August, 1981

Address: S/o Sh. K.L. Chalana, B-301, Silver Arcade, Akota, Vadodara, Gujarat-20
Linguistic Abilities: English, Hindi, Punjabi and Gujarati