Local Trial Manager - outsourced to sponsor
- Experience Level
One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. Enter: the Strategic Solutions Division.
Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.
We are seeking an experienced Local Trial Manager to work as an integral part of our pharma client’s study team. The key function of the Local Trial Manager is to provide operational country oversight and monitor progress of local activities of global studies by project managing a clinical team at a country level.
- Working throughout the lifecycle of the trial, from start-up through to database lock and closure activities, key responsibilities will include:
- To manage the local execution of study activities, leading the local trial team of on-site monitors (Site Managers) and Clinical Trial Assistants; providing them with the necessary tools and training to collectively succeed as a team
- To serve as the primary point of contact at a country level and report study progress to key stakeholders
- To lead the feasibility and study start-up process; setting criteria for site selection and managing the site assessment process and proposing sites to the wider global study team
- To provide expert input into, or even independently create key study plans
- To develop and implement the use of local study tools (eg recruitment plans, risk management plans)
- To track the reporting of SAEs
- To maintain and update trial management systems (with the support of a Clinical Trial Assistant)
- To plan and participate in investigator meetings
- To review visit reports for completeness and adherence to the protocol and to identify site issues and trends
- To collaborate with other study team members as well as investigators and other site staff to build strong working relationships
A typical working day may include creating study documents, meeting with your team, sharing your expert local knowledge with other internal collaborates and even involvement with process improvement initiatives at a more global level. You will truly be a local study expert and will be expected to leverage your experience
- Organised, creative and confident in taking independent action.
- To ensure success within this role, the following are required:
- A proven track record within study/project management
- An ability to combine creativity, leadership and experience to empower a team to succeed
- Prior experience of budget forecasting, feasibility, study start up, on-site monitoring and site management
- Confidence in your decision-making abilities
- Oncology experience is required
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.