Senior Clinical Trial Manager UK/EU - Home based.
- Contract Type
Novella Clinical, a Quintiles company, is a medium sized, global CRO. We have a vacancy for an experienced Senior Clinical Trial Manager with a strong background in Oncology and preferably at least one other therapy area.
Senior Clinical Trial Managers are responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. They are functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. They assure clear client and internal team communication, process documentation and compliance with GCP and procedures set forth by Novella and its clients.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for all activities related to implementation and execution of clinical studies that include:-
Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.
Serve as client advocate within Novella.
Develop and implement Clinical Monitoring Plan.
Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
Coordinate site management activities:
Site identification, recruitment, and selection.
Regulatory document collection and review.
Overall scheduling and management of all site visits.
Develop site/monitoring tools and training materials.
Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
Coordinate and oversee daily operations of clinical monitoring team:
Set and enforce project timelines with the assigned study team.
Coordinate remote review of clinical data within EDC system.
Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
Review and approve trip reports and follow-up letters within required timeframe.
Schedule and manage weekly CRA project team meetings.
Ensure CRAs assigned to team receive therapeutic and project-specific training.
Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
Manage project milestones and proactively address deficiencies:
Attend and provide information at monthly projections meetings.
Attend and provide information at weekly client teleconferences/team meetings.
Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.
Manage CRA performance:
Define and implement functional standards, goals, and expectations with clinical monitoring team.
Serve as CRA mentor and perform accompanied field assessment visits as required.
Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
Ensure that the appropriate Novella and/or sponsor SOPs are followed.
Ensure all project documentation is appropriately filed per Novella SOPs.
Assist PM in preparation of audit responses, as appropriate.
Assist PM with preparation of information for inclusion in monthly report to client.
Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
Define the scope of work with the client and clinical monitoring team.
Assist PM in identifying and generating changes in scope and notify client of potential changes in scope.
Review and approve CRA travel expenses and time sheets.
Prior experience as Clinical Trial Manager (2 years)
Life Sciences degree
Strong background in oncology and one other area.
Excellent written and verbal communication skills with fluency in English.
Ability to work independently, prioritise and work with a matrix team environment.
Wllingness and ability to travel domestically and internationally, as required.
This role is permanent, full time and home based in the UK/EU.
Key words :- Senior Clinical Trial Manager, Senior Clinical Study manager, Clinical Trial Manager, Study Manager, Oncology