Local Study Manager
- Experience Level
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.
Our Local Study Managers (LSM) are at the heart of our studies and play a pivotal role in our success.
In this current role, you will be assigned 100% to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives in oncology, general medicine and eye care. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.
Working in a fast-paced, client-focused global environment, our Clinical Team Managers are at the heart of our project teams and our company. As a Clinical Team Manager 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. You will need to ensure consistent implementation of PRA methodologies during the different phases of the study. As a LSM, your responsibilities will include:
- To serve as the primary liaison and primary point of escalation for clinical activities and team issues, interacting with clients, vendors and other PRA functional areas
- To lead a team of Clinical Operations colleagues (CRAs, In House CRAs and Start Up Leads)
- To collaborate with Project Management to build and foster the client relationship 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 will liaise with Clinical Operations Managers to resolve resource and performance issues and contribute to Business Development activities participating in proposals and bid defenses as needed. Additional tasks include trip report review, forecasting and project management of the study start up process across your region.
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
- Fluency in Danish and English
- Right to live and work in Denmark. PRA does not sponsor work visas.
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 is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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