Will oversee an in-house and remote team of Clinical Research Associates (CRAs), ensuring that the monitoring of studies are planned and implemented and that global country and site targets are achieved, in compliance with ICH/GCP, TRI SOPs and all other applicable regulatory requirements.
- Provide management to the CRAs to ensure that their role and contribution is optimised: providing feedback, setting clear tasks and objectives and coaching team members on a regular basis
- Manage and assess/mitigate risks and help plan timelines for deliverables
- Mentor, train and contribute to the development of junior CRAs
- Ensure CRAs organise and conduct study site initiation meetings
- Setting up systems/trackers and SOP’s to support CRA activities to monitor progress of site and countries.
- Serve as primary communication/escalation point for RPMs and CPMs
- Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
- Responsible for planning and delivery of successful Ethics committee submissions including preparation of trial related documentation (site contracts, letters of agreement, confidentiality agreements) where relevant.
- Setting up and monitoring the systems whereby the CRAs can manage patient recruitment strategies to increase patient accrual into studies (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
- Review monitoring reports and provide coaching to CRAs as needed to ensure compliance with protocol and GCP requirements
- Comply with all applicable laws / regulations of each country in which we do business
- Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians
- Report legal, compliance and ethical violations in a timely manner
- Develops and maintaining collaborative relationships with investigational sites
Desired Skills and Experience:
- Proven clinical trials project management and leadership experience
- Life science or other relevant degree
- Excellent organisational skills
- Proven ability to develop and update working practices
- Flexible and effective project management, communication and negotiation skills
- Ideally a strong understanding of cardio vascular disease and treatment
- Proven analytical thinking and decision making skills
- Strong and proven customer engagement
Candidates will need to have current and valid eligibility to work in the UK in order to be considered for this role.