Quintiles and IMS Health have come together to become IQVIA, The Human Data Science Company. Inspired by the industry we help, IQVIA commits to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.
Post : Manager, Clinical Operations
Job Description
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. PURPOSE Manage the human, material, system and fiscal resources to provide clinical monitoring services within a designated office, country or region. Ensure that clinical staff (CTAs, CRAs and/or CRSs) gains the necessary skills to perform their respective job responsibilities.
RESPONSIBILITIES
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
• Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
• Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
• Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
• May fill in as a CRA or CRS for a defined project or to assist with milestone achievement on a temporary basis.
• May participate in clinical operations quality or process initiatives.
Candidate Profile
• Bachelor's degree in a health care or other scientific discipline or educational equivalent; 7 yrs of clinical trials experience including 3 years experience in a leadership capacity; or equivalent combination of education, training and experience”
• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines • Strong leadership skills
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English
• Excellent organizational and problem solving skills
• Effective time management skills and ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Regular travel, approximately 30% of work week
Additional Information
Experience : 3-7 years
Qualification : B.Pharm, B.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Operations
Job ID: R1095265
End Date : 5th October, 2019
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