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Title:

[QUOTE=Guest-IJT;125503]DR. HARSHA YOGESH MASKE
158/4877, Takshashila CHS. 
KANNAMWAR NAGAR-1, 
VIKHROLI (E),
MUMBAI - 4000 83
(M) – 9930924445
 022-25796510
 harshamaske AT rediffmail.com

DATE OF BIRTH : 26TH July 1978

Have faced: DCGI AUDIT
 EMEA AUDIT
 TURKEY AUDIT
 Preparing for ---USFDA AUDIT.

SKILLS : medical adviser for one pharmaceutical company based in mumbai

medical writing on-------
1. 1.Product monographs

2. Packaging leaflets of pharmaceutical products

3. Doctors training programmes

4. PowerPoint presentations on different topics of 
a. medical sciences

5. Clinical trials planning

6. Lectures on Medical emergency treatment

7. Conducting clinical trials/ BA-BE STUDY

8. Knowledge of pharmacological drug dose

Working freelancing with internet based medical writing institute since last 13 months.
 
EDUCATIONAL QUALIFICATION:

B.A.M.S. (BACHLOR OF AYURVEDIC MEDICINE & SURGERY) Passed In Sept. 2002.

PROFESSIONAL QUALIFICATION :

- Post Graduate Diploma in Clinical Research -- from ICRI-Marol.

- Computers--- {Microsoft word, Microsoft power point, ms office, PDF files}.¬

TOTAL WORK EXPERIENCE IN CLINICAL FIELD - 6.5YRS. :

- Worked with St. George Hospital from August 2001 to August 2002 as ‘Duty Medical Officer’.

Responsibilities:

Casualty Unit – Emergency Trauma cases, Burn cases, Poison cases, Accidental cases etc.

Intensive Cardiac Care Unit – 
OPD –
Minor Surgeries

Worked with Sanjeevani Hospital from October 2002 to May 2004 as ‘ICCU Registrar’

Responsibilities:
Management of Cardiac Emergency patients

Intensive Cardiac Care Unit –

OPD –
Minor Surgeries.

Special OPD of tuberculosis patients—

- Samarth Clinic—own Dispensary set up since July 2004 to January 2007.
 
Ace Biomed Pvt. Ltd. (Clinical Research Organisation), Saki Vihar Road,  Andheri as a Physician since January 2007 to August 2007.

Principle duties and Responsibilities:

- Screening activity
- Conduction of pre-study screening (Conduct the complete Medical Examination of the volunteer) 
- Review of ECG for volunteer during screening.
- Recording details of activities in relevant documents 
- Review of the lab reports and recording details in relevant documents.

Study Day Activities:
- Conduction of Medical Examination of Volunteers/ Study subjects
- Conduction of Post Study Examination (Monitoring Vitals, Physical Examination, Systemic Examination)
- Review of ECG for subjects
- Review of Lab reports and recording details in relevant documents.
- Assisting in Hospitalization of Study subject.
- Recording details of activities of trial in relevant documents 
- Recording of adverse events and management of it with the intimation of principle investigator.
- Filling of details of adverse event form.
Others:

- To perform duties as provided under delegation of duties in absence of key personnel.
- Preparing final report of adverse event.
- Taking presentations on suggested topics by the seniors.

D.M.R.I. (DRUG MONITORING RESEARCH INSTITUTE, RABALE, and NAVI MUMBAI.)  since September 2007 till August 2008 as “SUBINVESTIGATOR”.

Principle duties and Responsibilities:

- To check for preparation of screening &the study day.
- To conduct Screening activity
- Conduction of pre-study screening (Conduct the complete Medical Examination of the volunteer) 
- Review of ECG for volunteer during screening.
- Recording details of activities in relevant documents 
- Review of the lab reports and recording details in relevant documents.
Study Day Activities:
- Conduction of Medical Examination of Volunteers/ Study subjects
- Conduction of Post Study Examination (Monitoring Vitals, Physical Examination, Systemic Examination)
- Review of ECG for subjects, Review of Lab reports and recording details in relevant documents.
- Recording details of activities of trial in relevant documents 
- Recording of adverse events and management of it with the intimation of principle investigator.
- Filling of CRFs related to medical examination; check in, vitals &adverse event form. 
Post study assessment:
- To give compensation to respective subject.
- To check post study lab reports.
- To handover all the documents of the study related to clinical  department to the project management department& to the  investigator.
Others:

- To arrange for the meeting about upcoming studies with the investigator, project coordinators & CRAs.
- To perform duties as provided under delegation of duties in absence of key personnel (project coordinator &investigator).
- Preparing final report of adverse event.
- Taking presentations to train the staff.
Currently working with Raptim Research Ltd.(J.B. Chemicals Pharma) as a co-investigatorfrom September 2008 till date.
Along with all above responsibilities,

1. Interact with ethics committe.
2. Schedule the clinical trials.
3. Interact with sponsors & held meetings with them.
4. Preparing study protocols , clinical study reports.
5. Preparing e-CTDs of study reports for submission to USFDA.
LANGUAGES KNOWN : English, Hindi Marathi and Sanskrit

HOBBIES : Music[/QUOTE]

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