Job Openings for Pharmacy professionals (9 posts) to work in ICMR as Consultant | Salary upto Rs 1 lakh per month

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For Project Management Unit for 'TB Vaccine Trial'

Consultant (Senior Project Manager)

Essential Qualifications :
Post Graduate Degree (MD/MS/DNB/Ph.D) afters MBBS with one year of demonstrated experience in clinical research/Biomedical Research from reputed Institution.
OR
MBBS or equivalent with four year of clinical experience in Government Institution of which 2 years should be demonstrated experience in clinical research/Biomedical Research from reputed Institution.
OR
1st class Masters in M.Pharma , M.Sc in Pharmacology/Medical microbiology/ Biochemistry/ Biotechnology with 4 years of demonstrated Experience  in clinical research /Biomedical Research from reputed Institution
OR
2nd class masters in M.Pharm , M.Sc in Pharmacology/Medical Microbiology /Biochemistry/ Biotechnology / Clinical Research with  Ph.D in any of the above disciplines with 2 years’ post Ph.D demonstrated experience of clinical research/trial.

Desirable
• Experience in conducting  clinical research/Biomedical Research.
• Experience in establishing clinical trial sites, management 8c implementation of trials and managing and maintaining databases for quality systems.
• Able to write& review SOPs and logs relevant requirement for trial sites.
• Able to prepare project management plan, study monitoring pan for regulatory clinical trials
• Thorough knowledge of Schedule Y, new clinical trial guidelines. GCP, GCLP, ICH guidelines and regulatory requirements am new clinical trial rules for conduct of clinical trial.

• Good communication skills

Age Limited as on date : up to 70 years

Nature of duties
• Establish and ensure that all processes for conduct of vaccine trials, CRFs, data management etc. are in place for ensuring expected performance.
• Prepare detailed project management plan and safety management plan and ensure execution as per plan.
• Prepare data management plan with data manager and ensure preparation of statistical analysis plan with help of statistician.
• Communicate with sites for ensuring smooth conduct and support as and when required.
• Co-ordinate with monitoring team for study compliance and management/monitoring and obtain weekly updated reports team.
• Submit updated site specific and consolidated progress report to Team leader/ Programme officer every week Troubleshoot with all sites for smooth conduct of vaccine trial, Prepare SAE management plan and Prepare and assist in preparing adverse event / serious adverse event narratives, safety reports, progress reports and quality trending reports.
• Will be responsible for site initiation and site management, monitoring timely reports of adverse event / serious adverse event by site Pls and communication with regulators.
• Report the status of the quality levels of the staff, systems and production activities.
• Keep upto date with all quality and compliance issues.
• Prepare interim and final Clinical report as per guidelines.
• Prepare relevant documents (note to files, protocol deviations etc.) and ensure timely submission to sponsor, IECs and Regulators.
• The job requires frequent All India travel to sites for monitoring, quality assurance and quality management.
• Ensuring operational approach of the vaccine trial arc in place
• Any other duty assigned by the PI or Programme officer.

Consolidated Emoluments : Maximum Rs. 1,00,000/- per month depending upon experience and knowledge.

Tenure : Initial for one year and may continue upto three Years

Syllabus for written examination : Degree level related to project work, if written test Conducted

Place of work : ICMR/DHR, New Delhi

 

Consultant (Scientific) Clinical Service - Two posts

Essential Qualifications :
Post Graduate Degree (MD/MS/DNB/Ph.D) after MBBS with one year of demonstrated experience in Vaccinc/drug trial/clinical research/Clinical management from reputed Institutions.
OR
MBBS or equivalent with four year of clinical experience in Government Institution of which 2 years should be demonstrated experience in regulatory Vaccinc/drug trial/clinical research from reputed Institutions

Desirable
• Experience in conducting Vaccinc/drug trial/clinical research/Clinical Management.
• Able to prepare safety reports and ensure the timely management and reporting of AEs an SAEs by sites by supporting them
• Experience in managing and maintaining databases for qualitysystems.
• Able to prepare SOPs for trial conduct and write safety reports and SAP' narratives.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct.
• Good communication skills

Age Limited as on date : up to 70 years

Nature of duties
• Monitor the clinical trial and Prepare strategy for site monitoring and timely completion of recruitment targets and follow -up visits
• Checking of resources and Site initiation
• Monitor vaccine trial, check all the source documents and completeness of data CRFs and ensuring timely completion of data entry in compliance with study protocol.
• Review SAE tracker and SAE document repository every 15 days
• Prepare a patient tracker and discuss with site PI to ensure compliance and minimize missing visits of subjects
• To match the tracker every week against recruitment target for each site and take necessary actions accordingly
• Discussion with Pi’s and project staff for patient compliance
• Review of Ensure that all processes contributing to the performance of aclinical trial arc conductedproperly.
• Prepare and assist in preparing annual reports and quality tr ending reports.

Consolidated Emoluments : Maximum Rs. 80,000/- per month depending upon experience and knowledge.

Tenure : Initial for one year and may continue upto three Years

Syllabus for written examination : Degree level related to project work, if written test Conducted

Place of work : ICMR/DHR, New Delhi

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