Manager of Study Start-Up
- 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.
As a Manager of Study Start-Up, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
Working directly with investigative sites across the EMEA region, the Manager of Study Start Up plays a fundamental role in our client’s drug development process. The main focus will be working independently to Lead the study start-up activities at a country level.
This role is home-based and can be based anywhere in Europe.
Reporting directly to the Site Activation Strategist, the key tasks will include:
- Collaborating with the Project Manager to define the site activation strategy and develop timelines
- Manage submissions including the coordination of submissions packages and responding to EC queries
- Manage confidentiality agreements with sites
- Hold accountability for the exchange and tracking of study documents and translations, including quality checking, delegating some of these tasks to a CTA when appropriate
- Providing study updates to the wider project team
- Proactively identify and resolve any site challenges, and implement mitigation plans to any risks to study start-up, identifying trends and triaging issues as needed
- Build productive working relationships with investigative sites
Interfacing with other key stakeholders in the business including the medical team and project management, the Manager of Study Start-Up’s expertise will be called upon to work independently, taking ownership for study start-up and adopting an autonomous approach to decision-making.
You are organised, confident and quick to learn.
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 proven track record of success in study start-up activities in either a CRO or pharmaceutical company, including EC submissions, managing timelines and driving delivery
- The ability to identify risk and make decisions
- Fluency in English
- The ability to communicate confidently and learn quickly are also key attributes.
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.