Global Site Start Up Lead

This is a fully remote position, open to applicants in Canada.

📋 Description

• Formulate the site startup strategy for each study.

• Supervise the tracking and evaluation of study metrics.

• Promote optimized strategies for site selection.

• Lead the creation, assessment, and coordination of site activation forecasts.

• Ensure thorough and compliant documentation of site startup materials.

• Collaborate with cross-functional teams and CRO partners to outline a comprehensive global country startup strategy.

• Monitor and maintain data on country intelligence.

• Assist with regulatory submissions as necessary.

• Guarantee timely completion of country submission deliverables.

• Direct and manage all facets of site startup activities.

• Act as the subject matter expert for critical site documents.

• Oversee CRO site startup management or the in-house site-facing regional SSU team.

• Lead the gathering and analysis of site intelligence.

• Supervise the preparation and approval of the site regulatory package.

• Represent SSU on cross-functional teams.

• Suggest and engage in process improvements across functions and departments.

⛳️ Requirements

• 4-6 years of professional experience.

• Proven interpersonal and leadership abilities.

• Capability to understand and execute operational strategic direction for clinical studies.

• A data-centric approach to planning, execution, and problem-solving.

• Strong communication skills, including verbal, written, and presentation capabilities.

• Proactive and disciplined, with the ability to meet deadlines, manage time effectively, and prioritize tasks.

• Ability to influence and negotiate with key stakeholders.

• Skill in fostering productive collaborations.

• Experience in the clinical drug development process, particularly in study startup.

• Demonstrated experience in vendor management.

• Technical expertise in trial management systems (CTMS, TMF) and MS applications, including (but not limited to) Project, PowerPoint, Word, and Excel.

• Familiarity with ICH/GCP and regulatory guidelines/directives.

• Strong project management skills, including interaction with cross-functional teams and organizational capabilities.

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Professional development budget.

• Home office setup allowance.

• Global team events.