£155000 - £165000 per annum
about 1 year ago
The successful candidate will be responsible for managing the planning, implementation, and
tracking of the clinical monitoring process. As the leader of the clinical operations team, the
candidate will work closely with the Project Manager to develop plans, monitor resource
allocation and ensure that clinical site management and monitoring is being delivered with
quality and efficiency. Will be responsible for coaching/mentoring and supporting the CRA
teams and representing the clinical operations function to the client as directed by the PM. May
have direct line management responsibilities for CRAs and will be expected to build positive
rapport with the team.
* Manage timeline and quality of Clinical Operations team deliverables. May or may not
include budget management.
* Proactively identify risks and escalate to PM and other appropriate functional leads.
* Together with the PM, ensure transparent communication both internally and externally
regarding study progress and issues.
* Develop and maintain study-specific clinical monitoring plan.
* Manage CRA resourcing, site assignments, visit schedules and serve as the initial point
of contact for clinical operations and monitoring issues.
* Monitor and track the preparation and completion of monitoring visit reports.
* Conduct project co-monitoring, assessment visits and team training as necessary.
* Plan and conduct training for the clinical operations team throughout the project lifecycle.
* May involve overnight travel.
* University/college degree (life science preferred) or certification in a related allied health
profession (i.e. nursing, medical or laboratory technology) from an appropriately
* A minimum of 6 years clinical research experience with at least 1 year Lead CRA or
other relevant team leadership experience is preferred, or a similar combination of
* Working knowledge of ICH Guidelines and GCP including international regulatory
requirements for the conduct of clinical development programs.
* Enthusiastic willingness to take ownership of projects and drive them forward.
* Excellent communication, planning and organizational skills.
* Demonstrated ability to motivate and drive stakeholders to meet deadlines.
* Demonstrated ability to build positive rapport with team members and clients.
* Demonstrated ability to mentor and train other CRAs in a positive and effective manner.
* In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the
critical elements of success.
* Customer-service oriented