Senior Manager, Global Site Start Up Lead

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

📋 Description

• Design and implement global site and country start-up strategies for intricate clinical trials.

• Recognize risks, dependencies, and develop mitigation plans.

• Lead activities related to site activation planning and forecasting to meet study milestones and timelines.

• Collaborate with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to facilitate study start-up execution.

• Track and assess start-up metrics, utilizing data and trends to enhance performance and guide strategic decisions.

• Oversee the collection and submission of regulatory documents, site initiation readiness, and milestone tracking.

• Provide leadership and guidance to CRO partners and internal teams to ensure high-quality and compliant start-up delivery.

• Act as the main escalation point for challenges related to site start-up.

• Proactively resolve issues and promote cross-functional alignment.

• Manage and nurture a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives.

⛳️ Requirements

• Bachelor's degree and over 8 years of experience in the pharmaceutical, biotechnology, or clinical research industry.

• Extensive background in leading global clinical trial start-up activities, including strategies for country and site activation.

• In-depth knowledge of ICH-GCP guidelines, clinical trial regulations, and global study start-up procedures.

• Proven ability to lead cross-functional teams and influence stakeholders within a global organization.

• Demonstrated experience in managing vendors and CROs, including performance oversight and resolution of issues.

• Exceptional project management, communication, negotiation, and risk management skills.

• Preferably, prior direct line management experience with accountability for staff development and performance management.

• Experience in supporting complex, high-profile, and global clinical development programs is preferred.

• Strong analytical mindset with a data-driven approach to forecasting, metrics analysis, and operational decision-making is preferred.

• Experience in driving process improvements and initiatives for operational excellence within Clinical Development is preferred.

• Advanced understanding of country-specific regulatory and site activation requirements across various regions is preferred.

• Ability to primarily work in a computer-based environment.

• Willingness to travel domestically and internationally up to 25% as necessary.

• Capability to engage in meetings across multiple global time zones.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations available for applicants with known disabilities or chronic illnesses.

• Remote work model.

• Travel requirements up to 25%.