Start Up Lead
- Experience Level
- Experienced (non-manager)
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.
Our Study Start-Up structure represents an integrated, dedicated, seamless team of experts, all striving to minimize cycle times. This is especially true of our dedicated and passionate Study Start Up Leads.
As a Start Up Lead, you will lead all aspects of Start Up activities at the regional level to achieve quick and successful activation of sites, overseeing and driving all aspects of study start up for your countries.
Working through until last site activated, you will lead and manage a team of Site Activation Specialists (across a group of countries) who perform local EC submissions, prepare IP release packs and support sites at a local level.
You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals.
Responsibilities will include:
- Adopting our unique start-up methodology to drive early and predictable site activations through oversight of all activities, driving delivery and compliance across the assigned region
- Coordinate study start up activities, coaching and mentoring as appropriate
- Working collaboratively with functional colleagues and sponsors to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Contracts and Clinical Team Management.
- Ensuring understanding and communication within each of your countries
Eliminating all potential causes of delay
- Overseeing compliance and reporting progress.
- If assigned as a Primary Start Up Lead, leading a monthly acceleration meeting and preparing reports for other internal stakeholders and the sponsor, coordinating a team of other Start Up Leads to ensure global success of study start up activities.
A typical day as a Start Up Lead could involve chairing a start up call, communicating with other functional leads within Regulatory or Contracts and training and empowering your team to resolve issues.
Fully supported by your functional management, whilst also benefitting from department training, best practice calls and participation in working groups, you will play a fundamental role in bringing treatments to market.
You are :
Focused, a true leader and with the drive to succeed.
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 life-sciences undergraduate degree (or be a licensed healthcare professional)
• A solid experience in managing study start up activities across a region, managing and meeting deliverables
• A proven track record in a leadership capacity
• A passion for study start-up which drives you to motivate yourself and others
• Previous experience of working in a CRO environment
• An attitude that fosters collaboration and a sense of shared focus within a team
Your health, family, career, money – the things that matter to you, matter to us. At PRA, the benefits 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.