Clinical Team Manager
- Experience Level
Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.
As a Clinical Team Manager (CTM) you will be dedicated to one of our global Pharmaceutical clients. As one of the world’s leading and most trusted healthcare companies they place their core values and commitment to scientific innovation are at the heart of everything they do.
The CTM will provide clinical trial management for in-house and outsourced studies in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice and will be accountable for the study delivery strategy and execution:
- Protocol and document development, review and/or finalize high quality key clinical documents including the full protocol for external and internal use in assigned trials
- Perform quality checks and follow-up on resolution of open issues
- Lead or contribute to the creation and execution of effective study delivery plans aligned with program goals and timelines
- Coordination of cross-functional study team activities, oversight of clinical vendor performance and metrics, planning and managing site start-up activities in collaboration with other functional lines
- May function as a liaison between clinical vendors and the sponsor to ensure understanding of expectations and scope of work
- Manage assigned study activities within agreed upon timelines and budget and in accordance with SOPs, GCP and all applicable laws and regulations
- Communicate with the cross-functional study team, the management team, and clinical vendors as required, concerning status and progress of the trial
- May coordinate study team training and quality checks to ensure cross functional study team members are compliant with use of required systems e.g. eTMF, CTMS, IXRS
- Build and maintain solid professional relationships with key opinion leaders and clinical study site staff
- Participate in SOP, work instruction and template development and improvement initiatives
- Conduct risk management discussions with the cross-functional study team and contribute to maintenance of a comprehensive risk management plan throughout the study lifecycle
An innovator, motivator and delivery-focused.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Potential to lead cross-functional team – set priorities and performance targets in a global
- effectively plans, co-ordinates and facilitates delivery of study team objectives
- understand the accountabilities of study delivery team members
- Creative thinker - able to adapt to modern approaches to study delivery
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Effective problem solving and conflict resolution skills with a solutions-oriented mindset
- Appropriate project management skills
- Strong influencing and stakeholder management skills
- Strong communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Solid experience of study management at CRO or pharma company
- A BA or BS degree in a health or science related discipline
- Fluency in English
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com