12 Month - Local Trial Manager - FSP - Remote

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an experienced Trial Lead/Manager to join us on a 12-month fixed term contract in the UK, this role is not open to Freelance or Independent Contractor applicants.

In this position you will be an invaluable team member, responsible for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the local level. You’ll contribute to project delivery through accurate planning and efficient execution of trials that bring speed and value to participating patients and sites.

Some specifics about this advertised role

• Ensure the trial is conducted in compliance with GCP-ICH, local regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.
• Creation, management and review of the trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
• Ensure appropriate trial-specific training of regional internal and external partners is performed in line with Trial Training Plan.
• Accurate planning and co-ordination of operational feasibility of regional trial timelines and oversight of trial preparation to ensure trial team members are aligned and on track.
• Verify and provide input into the country and site level feasibility and operations unit commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions.
• Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value.
• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in every role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• BS/ BA degree is required.
• Minimum 5+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 clinical trials. 
• 3-5 years leading end to end clinical trials
• Excellent decision-making, analytical and financial management skills are essential to this position