CRA Manager
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Job Type | Permanent Full Time |
Location | City of London |
Area | Central London, UK |
Sector | Clinical Research |
Salary | See Job Description |
Currency | GBP |
Start Date | 31/10/2018 |
Advertiser | remoteapi |
Job Ref | BBBH712_1539861287 |
Job Views | 42 |
- Description
CRA Manager
Pop science is delighted to offer an opportunity with one of our partners in Central London who have recently launched a new CRO to add to their continued success within the industry.
Uniquely you will have the backup and support of a highly regarded institute as well as a committed and enthusiastic team of colleagues.Due to their continuing success we now require a CRA Manager to join them ,Office based in Central London. Ltd or Paye
As the Clinical Research Associate Manager will oversee an in-house and remote team of Clinical Research Associates (CRAs), ensuring that the monitoring of studies is planned and implemented and that global country and site targets are achieved, in compliance with ICH/GCP, SOPs and all other applicable regulatory requirements.
Here's an idea 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 project manager for assigned studies.
- Serve as primary communication/escalation point for Sponsor 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 recognise yourself here :- Proven clinical trials project management and leadership experience Min 5 years
- Must have CRA experience
- Must have line management experience
- Life science or other relevant degree
- Excellent organizational 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
- Excellent Project Management skills
- Excellent presentation, communication and organizational skills
- Good attention to details
- Excellent interpersonal skills and a good team player
Send your CV to Bryan@
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