Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.
The purpose of this position is to 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, Sr CTAs, CRAs, Sr CRAs, Principal CRAs and/or CTLs) gain the necessary skills to perform their respective job 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 have 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 act as a CRA or CTL for a defined project or to assist with milestone achievement.
May participate in clinical operations quality or process initiatives.
Bachelor's degree in a health care or other scientific discipline or educational equivalent;6 yrs of experience working on clinical trials with 3 years experience in a leadership capacity; or equivalent combination of education, training and experience
Occasional travel, approximately 30% of work week
Candidates should have a home based office in the North East or North Central part of the US
Oncology study experience preferred
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
Quintiles Transnational - 20 months ago
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...