Clinical Trial Manager

Are you an experienced Clinical Trial Manager? Do you have experience leading larger phase III Clinical Trials from planning to closeout? If you have excellent project management skills with ability to prioritise and collaborate with internal and external personnel we would love to speak with you!

We are recruiting for a Clinical Trial Manager to work for a leading rare disease therapeutics company that pushes boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients' lives.

The successful candidate will be responsible for the operational management of the clinical development program in multiple countries including documentation and reporting requirements. You will work directly with internal and external stakeholders to ensure successful completion of all clinical activities and project deliverables within the required time frame and budget.

This is a remote position based in the UK, but will require travel to meet with potential partners and internal and external stakeholders.

Responsibilities:

• Play a key role in Clinical Trial planning and execution
• Lead Phase III study day-to-day activities
• Provide strategic input and leadership in study planning and execution
• Responsible for study activities, including study start-up, maintenance and close-out, enrollment, data review, reports and overall study quality
• Provide expertise and leadership in the management of CRO, and other key vendors to ensure on target, in budget deliverables with strong oversight
• Effectively communicate with a wide range of people across different locations and cultures
• Liaise with CRO and clinical site staff to ensure optimal sponsor-site relationships
• Manage study plans and documents, coordinate study reports, and sections for Investigator's Brochure and Regulatory documents
• Manage systems for tracking various activities during Clinical Trials (e.g., tracking metrics, monitoring reports, data review and query resolution, etc.)
• Plan resources and tasks to meet study and program objectives for timely execution of clinical studies
• Contribute to Inspection Readiness activities as needed

Requirements/Qualifications:

• Bachelor's degree in a scientific/medical field with 5+ years of experience in clinical study management within a Pharmaceutical, Biotechnology company or at a CRO
• Experience leading larger phase III Clinical Trials from planning to closeout, particularly with a focus in Neurology & rare diseases
• Excellent project management skills with ability to prioritise and collaborate with internal and external personnel
• Experienced managing CROs, consultants, and vendors in a complex team environment
• In-depth knowledge of FDA, EMEA, ICH and GCP guidelines.
• Take pride in being a great teammate, savvy, self-motivated, and efficient
• Demonstrated track record of being a self-starter and troubleshooting independently
• Thrive in an environment where work is done both independently and on teams

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.