Clinical monitors and research associates

   Research & development scientists

   Medical and clinical investigators and study coordinators

    Physicians & medical liaisons

    Statisticians & data management professionals

    CMC/pharmaceutical research professionals

      Regulatory affairs professionals

    Project managers

     Brand team personnel

     Senior sales managers

    Strategic planners

Clinical Research

Organizing meetings with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator & staff.

Confirming the appropriateness of the IRB & ensure that all documentation required to initiate the study is complete. Screening & assessing Clinical Trial Patient.

Leading a team of supervisor and field workers for carrying out protocol related activities.

Taking consent, writing drug chart, filling chemo format and blood form.

Diagnosing the disease & writing the prescription to the various patients under Sr. Consultant.

Writing & administration of Chemo therapy protocol.

Covered collection of all data & remaining study supplies for return to the Sponsor.

Adverse Event Monitoring & Reporting as per Protocol requirement.

Ensuring that screening and enrolled ID’s come to clinic in time.

Clinical examination at screening, enrollment and whenever required.

Ensuring that confidentiality and privacy of subjects is maintained.

Clinical Trial Patient screening, assessment, enrolment and follow up and its execution as per protocol.

Administering test article at timely intervals as per protocol.

Setting project goals, put strategic plan into practice,

Improving team quality and data quality by testing procedures,

Increasing productivity & efficiency of staff.

Accountable for medical care of subjects and ensuring that medicines reach to them.

Updating knowledge of GCP, ICMR guidelines.

Retraining field – workers how to ask about adverse events and filling of CRFs,

Training mothers how to make artificial feeds, breast feeds, reconstitution of medicines, observe child condition and informing AE team if condition worsens,

Refusal management in screening and enrollment by making field visit.

Optimizing use of organizational resources.

Managing communication. Providing senior management into what is happening & where things are going.

Meeting with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator & staff, confirming the appropriateness of the IRB &

ensuring that all documentation required initiating the study is complete.

Monitoring study progress to assure compliance with protocol requirements, FDA regulations & Good Clinical Practice as directed by the Sponsor.

Monitoring & tracking patient enrollment & study progress. Ensuring the timely accurate & complete collection & submission of study data (CRF filling & checking updated)

Filling protocol deviation & filling CRFs promptly.

Identifying, addressing & resolving issues & problems as they might occur.

Error correction in CRFs as per GCP guidelines.

Ensuring collection of all data & remaining study supplies for reurn to the Sponsor,

Assisting the Sponsor in problem solving & provide consultation on study related activities.

Medical

Handling of casualty, seriously ill and dangerously ill patients.

Experience in History-taking, undertaking routine & diagnostic investigations & daily ward rounds.

Coordinating with the emergency team to ensure prompt response to emergencies.

Interfacing with specialists & multi-specialty units to ensure world-class standards of patient care.

Ensuring and monitoring administration of appropriate drugs to patients.

Handling patient counseling sessions,

Consent taking, drug chart writing, chemo format filling and blood form filling etc.

Filling adverse reaction form and managing the same.

RECENT MANAGEMENT IN PHARMACEUTICAL SAFETY 

Information Management (PIM) and case studies

Drug Development Process – From Discovery to Commercialisation

ACADEMIC

 M.B.B.S 1986 Allahabad. U.P

 M.D  (Pharma) 1991 Allahabad. U.P

 Senior Resident - 1993-1997-LHMC. Delhi           

 Diploma in Pharmacovigilance ICRI- (New Delhi) Dec 2008

Fellowship Clinical  Research – Apollo Hospital. Dec 2008

International Business Management Chennai- 2003

TEACHING EXPERIENCE