Study Start Up Leader

Our international CRO Client is looking for an experienced clinical research professional to join their team in the following role:
Study Start Up Leader
The Study Start-Up Leader (SSU Leader) is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor during the start-up phase of a project to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The SSU Leader may have overall accountability for the execution of the study start-up strategy on the project when a Clinical Operations Leader is not resourced. In case of stand-alone projects, may act as Project Leader for projects involving a small/medium number of countries, where no Project Leader is assigned. Tasks assigned as responsibility include all study start-up aspects.


Key Accountabilities

Project Initiation & Planning
Manages study start-up activities, in small or medium size studies
Provide input to project tools, PL project plan, Central File Maintenance Plan
Provide input to the format and content for sponsor reports
Provide input to and oversight of site selection strategy plan
Develop site selection plan for the team
Review and provide input into patient recruitment plan and retention plan
Ensure all team members have access to tools and documents
Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program
Develop study start-up plans, tools and forms

Project Implementation, Control & Evaluation
Provide Leadership and direction to study start-up project team members Identify, organize and deliver (where appropriate) study specific training in collaboration with PL and PS
Evaluate and identify resourcing needs during the start-up phase of the project
Provide productivity targets to study start-up project team members
Provide performance feedback on team members as appropriate
Address identified and escalated site issues and drive to closure
Early recognition of areas of potential problems and provide input to contingency plans
Monitor study timelines, patient recruitment and retention to ensure successful outcome of the FPI and LPI milestones of the project
Oversee maintenance and quality check of CF until all sites are initiated
Maintain and assure quality of work generated and escalate and follow up as appropriate Ensure appropriate handover between project team members Implement and instigate process improvements within the project
Provide input to the Revenue Recognition forecast during the start-up phase Identify changes in scope and liaise with Project Leader
May be required to visit site(s) as per client or project demands
Participate in client, investigator and team meetings
Prepare, participate in and follow up on audits / inspections
Participate in all required applicable trainings

Experience:
Relevant Work experience in clinical research
Competent in written and oral English
Substantial experience in clinical research including relevant experience as a team Leader in Clinical or Study Start-Up functions or proven experience in coordinating clinical trials
Degree in a life science, nursing qualification or relevant experience
Experience in Coordination of Clinical Trials ' Preferably as Associate Study Start-Up Leader or proven experience in a similar role.
Munkavégzés helye: Budapest