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Clinical Project Manager (Jan 2020)
A new opportunity has arisen for a Clinical Project Manager at Edinburgh Molecular Imaging Ltd, an imaging and pharmaceutical company focused on imaging and targeted radiotherapy in the field of oncology.
We are looking for a Project Manager to oversee a range of projects across the entire development pathway, ensuring that all projects are completed on time and within budget. EM Imaging is developing a range of products including systemic targeted radiotherapy, optical and positron emission tomography (PET) molecular imaging agents. The successful candidate will also be responsible for ensuring EM Imaging-sponsored clinical trials are planned and executed to the highest standards, in compliance with ICH GCP guidelines, SOPs and all applicable regulatory guidelines.
Key Roles & Responsibilities
- Design of clinical research programmes in conjunction with internal team, external strategic partners and KOLs
- Set-up and management of company sponsored studies, maintaining timelines, tracking budgets and coordinating regular reporting against project milestones and deliverables
- Manage the selection and subsequent oversight of a range of third-party vendors including clinical CROs
- Ensure the preparation of clinical trial related documentation meets scientific, regulatory and business needs, including Protocols and Investigator Brochures
- Manage the design of the statistical analysis plan in conjunction with the medical statistician
- Manage the monitoring of studies to ensure they are fully compliant with all relevant regulations
- Identify potential challenges and propose solutions (Risk based analysis)
- Produce and distribute status, resourcing, and tracking reports
- A life science degree, Masters or Ph.D. preferred
- An in-depth knowledge of ICH-GCP and regulatory guidelines
- Proven experience (~5 years) of clinical trial management, ideally across all stages of clinical development and in the field of oncology
- Strong communication, team working and organisational skills
- Willingness to travel when necessary
- In-depth working knowledge and understanding of the principles of GxP
- Experience in clinical development or regulatory affairs would be an advantage
- Excellent interpersonal skills, negotiation skills, and facilitation skills
- Strong analytical and problem-solving skills
- Ability to work well autonomously and within a multi-disciplinary virtual team environment
- Effective time management
The position is located in Edinburgh.