Job Description

We are helping this major CRO to source an experienced project manager to be outsourced to their prestigious pharma client. The successful applicant will have drive and enthusiasm to project manage a large team of CRAs (approx 12 which is a mix of office and field staff) on a large successful Breast Cancer study. The study is big with approx. 60 UK sites nationwide and over 500 pts recruited.

The position requires someone to be able to manage project plans in terms of deadlines, resource and budgets. The project manager will be a member of the study management team and represent the UK team at this forum. He/she will also be required to liaise with the marketing team for this drug. The position also involves being a mentor and support to the CRAs, going out on co-monitoring visits etc. Team motivation and team direction, focus and adherences to goals and deadlines are needed for this role.

The successful applicant will:

• Manage phase I-IIIb clinical trials conducted by academic and healthcare institutions across therapeutic areas worldwide within quality guidelines, timelines and budget.
• Measure progress against goals to achieve clinical research targets.
• Manage the budget associated with trials in selected therapeutic areas.
• Monitor patient recruitment at the global level.
• Ensure timely and accurate documentation and communication of study progress and issues.
• Ensure that required reports are generated within organizational guidelines.
• Ensure compliance with governmental and regulatory agencies.
• Coordinate QA and Health Authorities (FDA, EMA etc) audits.
• Interact daily with multifunction teams worldwide.
Qualifications
• University degree or equivalent (biological, science, nursing experience etc)
• At least 5 years experience in the Pharmaceutical Industry in clinical research, minimum 2 years monitoring, and managing clinical trials.
• Excellent written and verbal communication in English.

Qualifications/Skills Required

• Good knowledge of global clinical trials, drug development and Good Clinical Practices.
• Excellent project management skills.
• Able to take initiative, are results driven and innovative.
• Strong financial management and leadership skills