[Hiring] Global Site Start-up Leader @Parexel

Role Description

In this role, you will be accountable for the global execution of site activation for assigned clinical trials, performing responsibilities with moderate oversight. The Global SSU Lead is accountable for ensuring site start-up is efficient, timely, and in accordance with sponsor Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes to ongoing process improvement initiatives.

• Develop the site start-up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks.
• Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and evaluate CRO performance and implement corrective actions.
• Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making.
• Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
• Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
• Partner with cross-functional and CRO partners (where applicable) to develop a comprehensive global country start-up strategy.
• Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
• Support regulatory submissions as needed, including activities such as providing required site documentation and coordinating submissions to Central Institutional Review Boards (CIRBs).
• Lead and oversee all aspects of site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking.
• Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites.
• Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
• Recommend and participate in cross-functional and department process improvements.

Qualifications

• Bachelor degree
• Minimum 4 - 6 years global SSU management and regulatory submission experience in Pharmaceutical/CRO industry
• Understanding of clinical study start-up requirements and working knowledge of relevant documentation
• Project Management and Clinical Trial Management experience
• Demonstrated interpersonal & leadership skills
• Ability to understand and implement the operational strategic direction for respective clinical studies
• A data-driven approach to planning, executing, and problem-solving
• Effective communication skills via verbal, written, and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate across key stakeholders
• Ability to build productive study team collaborations
• Experience in the clinical drug development process, with expertise in study start-up
• Demonstrated vendor management experience
• Technical proficiency in trial management systems (CTMS, TMF) and MS applications
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross-functional team interaction, and organizational skills

Benefits

• Premium salary
• Attractive benefits
• Medical care plan: Health, Dental & Vision
• Life Assurance
• Excellent work environment
• Culture of teamwork and collaboration
• People who motivate and face challenges together
• Innovative technology
• Excellent training