Clinical Operations (CRA Manager)
An exciting new opportunity with a well renowned Research Institution in central London has become created.
We need an expert Office Based CRA Manager with experience as a line manager(Crucial) as well as study start-up, site initiation, regulatory and monitoring in Real World data through to site and study close-out.
As the CRA Manager you 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, SOPs and all other applicable regulatory requirements.
For this long term contract to perm we are looking for a candidate who has had a solid career background as a CRA ,Confident leader and problem solver, adapt and find solutions to any problems, You should already have experience of full line management of CRA'S and other associate staff within the teams you have worked alongside.
Here is a snap shot of what you will be doing:
- 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
You should already recognise yourself here:
- 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.
For more information forward your current CV with salary expectations to
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