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.
This position can be home based anywhere in the US.
Financial Review as needed for BSC GFR ROW
- Oversee all aspects of resourcing for the Boston Scientific GFR model
- Work with BSC internal study teams to complete resourcing for BSC projects
- Work with Line Managers to complete requests for resourcing
- Provide specific resourcing metrics to BSC as needed
- Responsible for liaising with internal and external Management and Senior Management supporting execution of Work Order specifications; facilitate in-take of clinical studies; participate in the hiring of new staff; develop and document related processes
- Oversee and conduct risk assessments of project deliverables and timelines across the client portfolios across multiple therapeutic areas
- Project and support appropriate allocation of FTEs via continual assessment of the client portfolio needs during a period of tremendous internal growth
- Build and Maintain a variety of tools, trackers and reports to aid in assessing capacity, projecting FTE need, provide work order specific and GFR metrics, assessing compliance to process and other ad hoc reporting
- Oversee staffing requirements (tracking, recruiters) for BSC GFR
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...