We are always looking out for talented people and you could be the perfect fit for our team without us having realised this yet. Please see below for open positions.
To send us a CV, please email to firstname.lastname@example.org
Please include a cover letter.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
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.