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.
Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you'll be at the heart of our client's innovation. As Clinical Team Manager, you will be dedicated to one of our global pharmaceutical clients; a fast-growing biotech company with one of the most exciting product pipelines in the industry.
This global client develops breakthrough innovative medicines to improve and extend people's lives with targeted therapies for cancer. Join the fight against cancer at this sponsor who is running more than 60 clinical trials globally in the area of solid tumors and hematologic cancers.
Our Clinical Team Managers are at the heart of our studies and play a pivotal role in our success. As a Clinical Team Manager, you may be assigned regional or global clinical study leadership. You will create and maintain all relevant clinical project documents and tools pertinent to the study, ensuring compliance with company, applicable regulatory and customer requirements.
As a CTM, your responsibilities will include:
- To lead a team of Clinical Operations colleagues (CRAs, In House CRAs)
- Oversees and supports clinical operations:
- Study start-up (submissions, vendor/CRO selection, cost/time estimation)
- Monitoring (reviewing and approving monitoring reports, efficient data entry, ensure TMF is maintained, liaise with clinical supply chain)
- Close-out (reconciliation, database lock, inspection readiness).
- Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
- Escalation point person to next level of study oversight/governance as necessary
- To collaborate with Project Manager and/or Project Director at client-side and provide data as required for clinical performance metrics and project status metrics - applying and drawing conclusions between project activities/deliverables and project metrics and initiating measures to improve metrics.
- To focus on proactive risk identification and management, including implementation of CAPAs where applicable.
- You liaise with Clinical Operations Managers to resolve resource/performance issues.
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
- 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
- Min of 2 years of experience providing leadership in clinical trials at CRO or pharma company
- Experience working in oncology studies preferable
- 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. 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