Study Activation Manager
- Experience Level
PRA has been contributing to the battle against COVID since day 1 and whilst there is no doubt that we are currently working in unprecedented times, PRA has been great at creating a sense of unity amongst our employees and globally. Our Leadership have remained dedicated to ensuring that our employees supported and productive so if you join PRA you can expect increased technology and IT support for all global home-workers as well as access to extensive health & wellbeing resources.
Working directly with investigative sites across the country, the Site Activation Manager plays a fundamental role in our client’s drug development process. The main focus will be working independently to manage the study start-up activities.
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, 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 Site Activation Manager’s expertise will be called upon to work independently, taking ownership for study start-up and adopting an autonomous approach to decision-making.
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 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.