We are currently looking for a Clinical Project Manager to join a growing biotechnology company based in the London area. As the Clinical Project Manager you will be responsible for contributing to the execution of projects per development plan, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices.
You will take responsibility of clinical trial management of programmes using industry standard project management tools and training materials and compliance with Good Clinical Practice, standard processes and procedures.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Project Manager will be varied however the key duties and responsibilities are as follows:
1. Accountability for leading the execution of data generation activities for projects assigned by the Associate Director or Director Clinical Operations. You will serve as the single point of end-to-end accountability for assigned projects, leading the Study Management Team for global, regional or complex studies, interfacing with the Clinical Teams, functional representatives, stakeholders or other internal/external sponsors, external service providers e.g., contract research organisations (CRO). Primary accountability at the trial level. This includes all project activities staring from protocol development to delivery of the final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements
2. You will provide operational leadership to the execution plan and defines risk mitigation strategies and ensures implementation thereof. Co-ordinates activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning and decision making. Support project team members to be compliant with current ethical and regulatory guidelines and requirements
3. Support budget negotiation and trial agreements with sites. Oversee program budget and provide input. Responsible for outsourced vendor management oversight and invoicing . Responsible for the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project
4. Accountable for oversight of TMF review and maintenance and for clinical operations inspection readiness. Collaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly. Tracks project progress against timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated region/countries. Provide regular status updates to Clinical Trial Team and Management. Ensures required reports are generated and available for real time tracking of project status.
To be successful in your application to this exciting opportunity as the Clinical Project Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a biologics focussed discipline.
2. Proven track record of clinical trial management, including experience of an advanced medicinal product and working within a commercial setting.
Key Words: Clinical Trial | Clinical Project Management | Clinical Trial Manager |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Eve Hegarty
- Phone: 0131 202 9700
- Reference: J5634308
Website: Hyper Recruitment Solutions
- Posted: 14th January 2021
- Expires: 11th February 2021