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Senior Executive - Clinical Research

By: Pharma Career | Views: 605 | Date: 25-Oct-2010

Summary

Experience:
2 - 3 Years
Location:
Mumbai
Compensation:
Rupees 3,00,000 - 4,00,000
Education:
UG - B.Pharma - PharmacyPG - Post Graduation Not Required
Industry Type:
Medical/ Healthcare/Hospital
Role:
Clinical Research Associate/Scientist
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

Clinical Research Executive {Sr. Exe}

Job Description:

The candidate should have in-depth therapeutic and protocol knowledge, as provided during company training and will be responsible for clinical trials, in accordance with protocols, company SOPs, Schedule-Y and ICH- GCP guidelines. The candidate will:

• Support the execution of clinical deliverable and study timelines

• Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress.

• Manage resource allocation, utilization and planning

• Prepare budget forecasts and management reports for assigned projects.

• Collaborate with other functional groups within the company such as data management, pharmacovigilance, and QA where necessary to support milestone achievements and to manage study issues and obstacles.

• Provide ongoing training and support to the clinical team and ensure their overall development.

• Conduct frequent team meetings and ensure regular communication.

• Undertake regular training for the study team with periodic co-monitoring visits to sites, to boost performance and efficiency.

• Serve as a mentor to the CREs on the study

• Develop study related checks and controls

• Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with Head-Clinical Operations. Develop proactive contingency plans to mitigate clinical risk.

• Identify quality issues within the study through regular review of the clinical team communications including site.

Candidate Profile:

The candidate must have a bachelor’s degree (in pharma/science) with at least 2-3 years of working as a CRA in a pharma/ CRO/ biotechnology company and should have good communication skills.

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop/computer are a pre-requisite for the post. Willingness to travel across the country, at short notice would be expected of the candidate.

Job Description

Clinical Research Executive {Sr. Exe}

Job Description:

The candidate should have in-depth therapeutic and protocol knowledge, as provided during company training and will be responsible for clinical trials, in accordance with protocols, company SOPs, Schedule-Y and ICH- GCP guidelines. The candidate will:

• Support the execution of clinical deliverable and study timelines

• Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress.

• Manage resource allocation, utilization and planning

• Prepare budget forecasts and management reports for assigned projects.

• Collaborate with other functional groups within the company such as data management, pharmacovigilance, and QA where necessary to support milestone achievements and to manage study issues and obstacles.

• Provide ongoing training and support to the clinical team and ensure their overall development.

• Conduct frequent team meetings and ensure regular communication.

• Undertake regular training for the study team with periodic co-monitoring visits to sites, to boost performance and efficiency.

• Serve as a mentor to the CREs on the study

• Develop study related checks and controls

• Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with Head-Clinical Operations. Develop proactive contingency plans to mitigate clinical risk.

• Identify quality issues within the study through regular review of the clinical team communications including site.

Candidate Profile:

The candidate must have a bachelor’s degree (in pharma/science) with at least 2-3 years of working as a CRA in a pharma/ CRO/ biotechnology company and should have good communication skills.

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop/computer are a pre-requisite for the post. Willingness to travel across the country, at short notice would be expected of the candidate.

Keywords: Clinical Research

Company Profile

Asian Heart Institute (AHI) has been set up with an aim to provide world-class cardiac care in India. It is situated at the Bandra-Kurla Complex (BKC), a mere 15-minute drive from the domestic and international airports. The hospital promises to provide quality cardiac care to patients at reasonable costs.

A dream of leading cardiac specialists of Mumbai, Dr. Ramakanta Panda, Dr. Sudhir Vaishnav, and Dr. Tilak Suvarna, AHI was set up with a holistic approach to heart care based on ethics, quality care and professional backed by competitive prices. It prides itself on quality in terms of design, patient care, medical, paramedical and general staff and infrastructure facilities.

The hospital has a Patient-centric design with stress on safety and comfort of Patients. All Patient areas have been designed to minimize the risk of infection. Internationally accredited with ISO 9001:2000, JCI & NIAHO, AHI reaffirms its commitment towards world class cardiac care by being the highest accredited hospital in India.

The hospital was started to set a benchmark in quality care, ethical practice, reasonable costs and training for those in the profession. Patients are not charged premium rates for the care they receive. In fact, the charges are reasonable and probably even 10-15 per cent cheaper compared to other hospitals.
Contact Details
Company Name:
Asian Heart Institute
Executive Name:
Mr. Ravi Ranganathan
Address:
Asian Heart Institute
G/N Block, Bandra-Kurla Complex,
Bandra (East),
India.
MUMBAI,Maharashtra,India 400051
Telephone:
91-22-66986666

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