Senior Clinical Project Manager
My client is an industry leading and global organisation within the medical diagnostic sector. They are recruiting an exciting role within the Clinical Affairs Team with the responsibility of executing the company's global clinical studies and registries.
The role will be responsible for the planning, implementation, execution and management of clinical research studies. You will be responsible for executing high quality plans for project/clinical trials whilst also ensuring that budgets and schedule requirements are met throughout the process.
The post holder will be interacting closely with senior leadership across Medical Affairs, R&D, Legal, Finance and Marketing and external stakeholders such as Investigators managing Investigator Led Studies and CROs. This role will also have up to two direct reports also.
* Reporting on study progress and responsible for responsibility or identifying and communicating issues and risks whilst implementing a resolution plan, including managing expectations on unrealistic timelines
* Ensure all trial deliverables are met according to timelines, budget, and resource requirements
* You will be leading the investigator meetings and protocol training meetings and be accountable for all internal clinical meetings related to assigned clinical trials.
* The post holder will be lead the clinical protocol development process: responsible for clinical protocol development, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents; obtain approval from internal review boards.
* Collaborate with the Clinical leadership and investigators to ensure their feedback is adequately integrated into protocol
* Lead study start-up efforts including study feasibility and site selection
* Collaborate with Legal to create and approve Clinical Trial Agreements
* Forecast trial resources needs, including external costs: accountable for the development, management and tracking of trial budget.
* Create and maintain clinical project files to internal standards and regulatory requirements and meeting FDA/GCP/ICH guidelines
* Responsible for training, development and on-going support of the direct reports.
* Bachelor's degree or equivalent experience is required
* 7 years global experience as a Clinical Project Manager or relevant work experience
* Experience in diagnostic industry preferred, experience in medical device or pharmaceutical industry will be considered
* Advanced computer proficiency, especially MS Office
* Ability to travel 20 - 40% (domestic and international)
If you or anybody in your network is interested in this role then please get in contact with Marcus on 0121 726 9711
See more at: www.srgtalent.com/jobs
You must be eligible to work in the UK. Learn more
- Agency: SRG
- Reference: J33602
- Updated: 4th October 2019
- Expires: 25th October 2019