Clinical Team Manager
6 days left
- Experience Level
We don’t tell our employees what they should care about. They tell us. At PRA, Philanthropy, charitable giving and social responsibility are more than buzz words for us – they’re ideas we hold up as ideals. Our passion and commitment to improving lives extend far beyond our work and we believe that it is our obligation to empower ouremployees to find meaningful ways to respond to the needs of others around the world.
As a Clinical Research Manager you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.
Our Clinical Managers are at the heart of our studies and play a pivotal role in our success.
As a CRM, your responsibilities will include:
- Accountability for the performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- To be the Country point of contact (POC) for assigned protocols and proactively drive/track execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles.
- Forecasting country resource needs and serving local business needs (sign contracts, manage budgets as delegated)
- Responsibility for quality and compliance of assigned protocols in the country and oversee CRAs and/or CTAs and training compliance.
- Performing quality control visits, reviewing Monitoring Visits Reports and escalating performance issues and training needs to functional vendor and internal management as needed.
- Responsibility for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners.
- Overseeing country and site validations, site selection and recruitment in assigned protocols.
- Responsibility for clinical trial education to sites and act as the country POC for programmatically outsourced trials for assigned protocols.
- Representing the client in Pharma industry issues and in seeking influence in external R&D environment.
Proactive, collaborative, innovative.
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:
- A relevant degree or be a licensed health-care professional
- A thorough knowledge of ICH GCP and an awareness of local and international regulatory authority regulations.
- A considerable amount of experience in clinical research / clinical operations with at least several years’ experience of managing clinical projects, including providing leadership in a multi-country / international setting, ideally in a CRO
- Self-evident experience of leading a clinical team to successful project delivery
- Finance management and forecasting skills
Your health, your family, your career, your money — the things that matter to you, matter to us. At PRA, the benefits just get better and better.
In additional to promoting a healthy work-life balance, excellent remuneration and benefits package, our commitment to our staff is only surpassed by our commitment to advancing treatment options available to patients: We understand the importance of supporting and investing in our people. With 20% of our employees promoted last year, we don’t need to tell you that your career will thrive at PRA. We know it. And we can prove it. As we grow, so will you. Come discover your PRA.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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