Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: Associate Clinical Operations Manager
Job Description:
• To manage all aspects of Clinical Research conducted within the Indian affiliate.
• Responsible for achievement of departmental objectives in order to meet Affiliate business and GPRD Study needs and the department is operated efficiently.
• Responsible for planning and tracking the conduct of the study in compliance with the study budget, the quality standards and timelines
• Line manager for assigned departmental team members in order to meet their personal development, project and departmental needs.
• Accountable for ensuring legislation, ICH-GCP guidelines, Abbott GPRD and Indian clinical research SOPs are maintained and followed on all studies.
• Developing/ reviewing clinical research documents, managing and training clinical team members and ensure training compliance of the whole CLINOPS team.
• Involved in budgeting of clinical trials and third party vendor management, managing logistics and coordinating with various department to ensure that study timelines are met and high quality data is generated and also to tack study finance on monthly basis and SOS
• Review and approve monitoring reports and appropriate information for local and central tracking systems within required timelines as assigned by COM.
• Maintain appropriate communication with relevant functional areas as defined in section ‘Key internal and external interfaces’.
• Undergo and maintain training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to ICH-GCP, Abbott GPRD SOPs and IQS processes and procedures, local SOPs, applicable regulatory requirements and study specific needs.
• Contribute to achieving satisfactory study audits with no critical and major findings.
• Ensure together with COM, appropriate delegation of study related responsibilities during absence.
Candidate Profile:
• Expected to have working experience in various areas of clinical research with different type of studies(Phase I to IV/BABE/Epidemiology/PMOS/PMS/PSS); literature review using advance software’s, designing protocol, ICFs, study budget, CRF with sufficient experience in performing several feasibility studies, site selection visits, site initiation visits, site monitoring visits and site closeout visits.
• Good working experience in coordinating audits and Inspections.
Leadership
• (Must) Good communication skill.
• Willing to travel for work.
• Team Player
• Active role model
Core
• Good knowledge of clinical research industry, ICH-GCP and schedule-Y guidelines.
• Willing to travel and stretch the work hours on need basis.
• Flexible enough to respond and resolve team conflicts as and when required.
• Minimum 5-6 years of work exp. in various capacities for clinical research in MNC CRO or MNC Pharmaceutical Company.
• Should have a line management experience of at least 3years.
Additional Information:
Experience: 5-6 Years
Location: Mumbai
Education: M.Pharm, MBBS, BAMS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Keyword or Job ID: 100708BR
End Date: 25th Nov., 2011
To Apply/Send your resume, Click Here
See All Abbott Jobs B.Sc Alerts B.Pharm Alerts Mumbai Alerts
See All Other Jobs in our Database
.png)
