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Study Start-up Lead

PRA - Australia - Australia,

Health, Medical & Pharmaceutical
Source: uWorkin


Full Job Description
Study Start-Up Lead Overview:
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 In House CRAs 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.

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 to a study 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 within a CRO environment, managing and meeting deliverables and a proven track record in a leadership capacity
A passion for study start-up which drives you to motivate yourself and others
An attitude that fosters collaboration and a sense of shared focus within a team

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.