Study Start-Up Leader (CEE locations)
Parexel International Corporation
The Study Start-up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/ approval, ICF customization/approval, EC and RA/ MoH submissions, SIV scheduling and activation requirements.
The Senior Study Start-Up Leader, is accountable as noted above including: Acting as study-level program lead, such as managing multiple protocol delivery for a Sponsor or asset development. Acting as an Enterprise or Biotech level lead and provide expert level knowledge on agreed partnership process. Additional responsibilities may include: Study Start-Up Leader mentorship, participation in training and support programs, fulfilling subject matter expert or process improvement roles within Clinical Operations. Key Accountabilities: Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance. Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools. Collaborate and communicate within the Global study team matrix to provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities. Participate in client meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics. Partner closely with both Functional Leaders and Local Site Managers to proactively identify study start up related issues Develop and execute corrective actions to mitigate risks to activation timelines Ensure that relevant - systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level). Deliver and maintain client-focused reporting to measure performance and proactively identify issues for resolution QualificationsRole requirements: Degree in a life science, advanced degree preferable Competent in written and oral English Proven client-facing relevant experience in healthcare, clinical research, project management or contract research organization Experience in a multi-national organization Prior Project Management experience preferable End to End study start-up experience & expertise preferred Knowledge of applicable international regulatory requirements and guidelines (i.e. ICH-GCP, and/ or EU-Directives) Strategic and creative risk management and contingency planning Ability to lead virtual teams across cultures and locations Excellent interpersonal, verbal, written and presentation skills Client-focused action-oriented approach to work Strong Leadership skills, with ability to influence both vertically and horizontally Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Able to work independently and manage assignments from a distance Sense of urgency and organization in completing tasks Strong understanding of cultural differences