Senior Clinical Project Manager

A clinical-stage biopharmaceutical company is advertising a vacancy for a Senior Clinical Project Manager to their office in Cambridge. The organisation prides itself on its deep pipeline of novel antibody-based therapies in a broad range of indications. The company's platforms have been designed to maximise the diversity of human antibodies produced in response to immunisation with antigens. This is an exciting opportunity to work with a dynamic company that uses state-of-the-art technology.

Job Responsibilities:

• To lead the clinical trial team (internal and external) tasked with delivery of a sponsored clinical trial.
• To assist in the selection of appropriate vendors for the conduct of sponsored clinical trials.
• To work with vendors to define operational details of sponsored clinical trials.
• To develop study management plans ensuring sponsor oversight of clinical trials in accordance with company procedures.
• To review vendor generated clinical trial related documents to ensure compliance with the objectives of the trial, company procedures, and relevant standards.
• To act as the key contact for trial associated vendors and ensure timely and effective communication between involved parties.
• To ensure essential documents allowing the reconstruction of each trial are generated, filed, and maintained.
• To manage trial budgets and track trial related payments to vendors
• To communicate progress and identify risks and issues arising on clinical trials to the VP Clinical Operations and other development team members as appropriate.
• To maintain awareness of, and ensure compliance with, company policies and procedures relating to quality standards within the company.

Skills and Requirements:

• Degree level education or nursing or other healthcare professional equivalent.
• Substantial Experience of managing outsourced clinical trials.
• Experience in clinical trials across a range of therapeutics areas and geographies, ideally experience of biological therapies; experience of oncology would also be an advantage.
• Excellent matrix management skills and ability to manage contractors and collaborators.
• Robust knowledge of GCP and related regulatory guidelines governing clinical trials in the UK, EU, and USA.
• Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors, including CROs and consultants.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 846 0646 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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