Medical Manager

BIJAL R PATEL

Clinical Research Manager

Tirupati Society, Nr Poonam Complex,

Waghodia Road-390019, Gujarat, India

Contact No. +91-728*******

E-mail:**************@*****.***

OVERVIEW

Highly dedicated, self –motivated and hard working with more than 17 years of total experience in Clinical Pathology Laboratory.

Well versed in QC functioning including reviewing of bioequivalence study protocols, Clinical and non clinical data, SOP and STP preparation.

Ability to guide a team of professionals to inspire them for giving their best in their assigned responsibilities of work

EXPERIENCE

SUN PHARMACEUTICAL INDUSTRIES LIMITED, VADODARA, GUJARAT. Manager, Clinical Pharmacology Unit Department- March 2007 to 3 rd

Aug

Key Responsibilities:

Pathology Laboratory related work:

Worked in Clinical Pathology laboratory as an in charge of Haematology and Clinical Pathology section.

Knowledge of analysis, data recording and interpretation as well as reviewing and approving of results as per software of CLIS system.

Maintaining strict quality norms in accordance to NABL guidelines.

Thorough knowledge of Internal and external quality control analysis and evaluations.

Good hands on Biochemistry, Immunology, Hematology automated instruments (Randox Imola, Abbott i1000, Cobas e411, Sysmex KX-21).

Preparation and Review of Standard Operating Procedures and other quality system related documents like work instructions, manuals etc. As per NABL Guidelines. Quality Compliance related work:

Retrospective review of trial/study related all documents like Informed consent forms, Case report forms, Trial master File (TMF) for regulatory submissions as a Quality Compliance (QC) Person.

Monitoring of various activities like Dosing, separation and other related activities during Bioequivalence/Bioavailability studies.

Issuance of Study and non-study related documents.

Maintain readiness to face planned and unplanned inspections by different regulatory agencies.

Assisted in facing inspection from different regulatory authorities like USFDA, ANVISA, MALAYSIA, MHRA, Corporate, DCGI and WHO and also involved in solving queries raised by them.

Other Key Responsibilities:

Department training coordinator- imparted training to subordinates.

Active member of Infection control committee of the department handling Vaccination of employees, Environmental monitoring, supervising Pest control activities and biomedical waste disposal.

TOPRANI ADVANCE LAB SYSTEMS, VADODARA, GUJARAT

Microbiologist- Feb 2002-Mar 2007

Key Responsibilities:

Routine bacterial cultures of samples like Urine, Pus, CSF & other body fluids etc.

Mycobacterium culture and identification from sample by conventional method and PCR Gene probe.

Operated instruments like BacT alert, Geneprobe, Bactec etc.

Expertise in AFB, gram’s stained microscopy.

Successfully faced NABL audit.

ACADEMIC CREDENTIALS

Masters in Medical Microbiology (1998-2002) Medical College, M S University, Vadodara, Gujarat.

Bachelor in Zoology (1996-1998) M S University, Vadodara, Gujarat.

HSC (CBSE, 1995) Sri Sathya Sai Vidya Vihar, New Delhi.

SSC (CBSE, 1993) New Green Field Public School, New Delhi. TECHNICAL SKILLS

Strong understanding of all aspect of the clinical monitoring and quality management process involved in BA/BE operations in accordance with ICH GCP, FDA Guidelines and in-house SOPs.

Good hand on software’s like (CLIS& EDMS)

Effective interpersonal, organizational and time managementskills.

Efficient verbal and written communication skills.

Effectively manages multiple priorities and delivery timelines. PROJECT

Title: “A Study of Aerobic Bacterial Flora In CSOM” Research Supervisor: Dr P.M BEENA, Associate Professor, Department of Microbiology, Medical College, Vadodara.

CONFERENCES / WORKSHOPS

Three day GCP training by CFPIE -USA at SPIL-Vadodara.

Attended International Symposium on Recent Advances in Molecular Biology, Allergy & Immunology (By Sun Pharma Advanced Research Centre), 2000.

ttended CME in Clinical Microbiology & Infectious Diseases (Global Hospitals, Hyderabad), 2004.

Attended 4

th

Annual Conference Indian Association of Medical Microbiologists

(Pramukhswami Medical College), 2006.

Attended VI annual conference, Indian Association of Medical Microbiologists

(C.U.Shah Medical College, Surendranagar), 2011.

Attended Preconference CME & 34

th

Annual Conference, Indian Association of

Pathologists & Microbiologists (The Gujarat Cancer & Research Institute, NCH Campus, Ahmedabad) Nov 2011.

COMPUTER PROFICIENCY

AREAS OF INTEREST

Clinical Pathology Laboratory

Quality compliance

Bioequivalence Studies

I hereby solemnly declare that all the information provided here is as per the best of my knowledge.

Date:

Place: Vadodara (Bijal R Patel)

Basic Windows operating system and softwares like Microsoft Office

(Word, Excel, PowerPoint)

Medical Software EDMS & CLIS

Contact this candidate