Clinical Project Manager
Our client, a specialty pharma company, are currently recruiting for a Clinical Project Manager to join their team on a permanent basis. People management experience is essential. This role offers hybrid working. There will be around 10% global travel to clinical trial sites.

Responsibilities

• Participate in external vendor qualification and selection related to clinical trials
• Manage contract research organization (CRO) and other external vendors supporting clinical studies
• Contribute to Design, planning and execution of multiple phase I to IV clinical trials to ICH-GCP standards
• Draft, review and contribute to study related documents and regulatory submissions
• Proactively contribute to identify potential study issues/risks and be able to recommend/implement solutions
• Provide input to both the CRO and internal quality assurance plans for the study and ensure internal and external study team adhere to the plans such as Monitoring plan, Data Management Plan, Drug Distribution and Reconciliation, Safety Plan
• Manage study timelines and report regularly to senior management on clinical study progress and issues
• Maintain oversight of clinical trial data collection and provide reports to Clinical Operations Manager (COM)
• Manage set-up and regular study meetings with vendors responsible for clinical trial deliverables and data quality
• Contribute to the development of study related documents (contracts, informed consent, protocols, Investigator Brochure, study plans, regulatory submissions for Scientific Advice etc.)
• Participate in development of Case Report Form (CRF) and the design and testing of clinical data base
• Participate in preparation of clinical study budgets and budget monitoring
• Travel to clinical trial sites (global locations) for study engagement and, if necessary, assess ICH-GCP and protocol compliance and oversee clinical trial monitoring and data quality
• Participate in training and mentoring of new staff
• Prepares and present metrics reports on study progress and other deliverables to COM
• Identifies risks and developing issues to COM

• Scientific Degree
• Previous experience of 6-8 years in clinical research and conducting of international clinical trials with at least 3-4 years in similar project management activities
• Computer skills and experiences in the use of standard office programs (Word, Excel, Power Point, etc.)