Study Start-up Leader

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Job Purpose:

The Study StartUp Leader is accountable for the of the study startup strategy and planning including the management and coordination of startup 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.

Key Accountabilities:

• Manage the study start up process through development of a site activation strategy and to oversee startup delivery and governance.
• Coordinate develop and articulate the critical path planning and implement as part of the Site Initiation Scheduling System Setup 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 startup progress metrics against targets/timelines (at a project/country/site level).
• Deliver and maintain clientfocused reporting to measure performance and proactively identify issues for resolution

Skills:

• Knowledge of applicable international regulatory requirements and guidelines (i.e. ICHGCP and/ or

EUDirectives).

• Critical thinking and problem solving
• Strategic & tactical thinking skills
• Conflict management skills
• Consulting skills
• Strategic and creative risk management and contingency planning
• Ability to lead virtual teams across cultures and locations
• Excellent interpersonal verbal written and presentation skills
• Clientfocused actionoriented 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
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Proficient computer and internet skills including working knowledge of MSoffice applications such as MS Outlook Word and Excel
• Ability to travel as required

Knowledge and Experience:

• Proven clientfacing relevant experience in healthcare clinical research project management or
• contract research organization
• Experience in a multinational organization
• Prior Project Management experience preferable
• End to End study startup experience & expertise preferred
• Competent in written and oral English

Education:

• Degree in a life science or relevant clinical trial experience especially in study start up activities
• Advanced degree preferable