Job as Require Clinical Head at CRO in Clinincal Research Company

It's provides end-to-end services for Phase I - IV clinical research, including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab.

It has research facilities in India as well as an established presence in various parts of Europe and the United States. As regional experts, we operate each region as a priority market. Our European HQ is in Frankfurt, Germany, in the United States our HQ is in Princeton, NJ and our Asian HQ is in Bangalore, India.

Post: Require Clinical Head at CRO

Job Description:
Duties and Responsibilities:
Overall incharge of the clinical unit and the bioequivalence study related activities Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion Criteria of protocol Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study Maintenance of Emergency Drugs List and ICU set-up Manage and coordinate the execution of Bioavailability/ Bioequivalance studies, Participate in Business Development, planning & developing future expansion and service diversification of CRO, preparation & review of budgets, setting and achieving the goals & vision set by CRO, Supervise and guide Investigators and other clinical staff for studies, Responsible for a robust system set based on GCP guidelines, SOPs and regulatory guidelines.

Implement GCP, perform duties of PI for conducting clinical studies, ensure QC, Facilitate audits, Training of staff, Liasoning with & promoting CRO,
Build procedures in compliance with established guidelines & regulatory requirements for BA/BE studies

Prepare and review protocols for clinical studies

Co-ordinate activities related to IEC
Communicate IEC related issues to all concerned
Ensure compliance to protocol, SOPs and Regulatory requirements
Coordinate with Project Coordinators for all project related matters
Coordinate with Screening In-charge for subject recruitment
Monitor and manage adverse events
Coordinate with panel of consultants to seek medical opinion as and when required
Ensure timely response to QA findings
Interact with sponsors on medical related matters
Handle safety related issues and ensure appropriate communication
Prepare and review reports for clinical studies

Candidate Profile:
Designation : Clinical Head /Clinical Pharmacologist
Qualifications: MBBS (with registration) & MD -Pharmacology
Experience : Experience in handling the Clinical Research/ Bioequivalence studies

Contact Details: malathi.a@alpconsulting.in

Additional Information:
Experience: 1-2 Years
Location: Mangalore
Education: MBBS (with registration) & MD -Pharmacology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 5^th Oct, 2012