Career for Clinical Studies Head/Clinical Pharmacologist in Manipal Acunova - alp consulting

Consulting was established in 1996 and since then, our story of success has been scripted by our investment in happiness resulting in improved productivity. Alp has grown to have the enviable reputation of being one of the most respected Search and Staffing companies in India and it is built on a strong foundation of commitment to quality and quest for excellence. Today, Alp’s service offerings are the benchmarks in the HR industry. At Alp, we believe that a perfect HR strategy that centres around the happiness of the employees is of paramount importance for every organization. Our state-of-the-art technology backed by proven processes along with a certain sensitivity when it comes to managing talent has made Alp the HR partner of choice.

Post: Opportunity for Clinical Studies Head/Clinical Pharmacologist in Manipal Acunova

Job Description:
Designation : Clinical Head /Clinical Pharmacologist
Qualifications: MBBS (with registration) & MD -Pharmacology
Experience : min 4 Years Experience in handling the Clinical Research/ Bioequivalence studies

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:
Experience :4 to 6 Years
Qualifications: MBBS (with registration) & MD -Pharmacology

Send your CV to: malathi.a@alpconsulting.in

Additional Information:
Location: Mangalore
Education: MBBS (with registration) & MD -Pharmacology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 7^th Oct, 2012