Senior Study Delivery Lead

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Direct and manage project activities effectively.

• Supervise project implementation, which includes planning, resource allocation, stakeholder communication, and risk management.

• Design, implement, and report on clinical studies and trials.

• Organize and lead the execution of non-interventional studies, ensuring adherence to timelines, quality standards, budgets, company policies, and scientific requirements from the initial protocol to the final study report.

• Coordinate and provide practical Study Protocols, Informed Consent Forms, operationally sound study documents, and Clinical Study Reports.

• Formulate strategies for study delivery, encompassing country selection, diversity, patient identification and engagement, recruitment plans, and digital tools/platforms.

• Evaluate, select, engage, and manage suitable vendors.

• Ensure adherence to ICH/GCP, ENCePP, and relevant study guidelines.

• Make informed risk-benefit decisions and implement risk mitigation strategies.

• Develop and oversee study-level budgets within the overall project financial framework.

• Forge partnerships and collaborate with therapy-aligned personnel and global teams.

• Lead study teams with clear accountability for successful study delivery.

• Act as the primary contact for interactions with lead scientists, data management, biostatistics, legal, compliance, and project management stakeholders.

⛳️ Requirements

• Ideally, you should possess experience as a Project Manager or a seasoned Senior Clinical Trial Manager with expertise in retrospective and prospective designs, post-authorization safety studies, real-world evidence, and epidemiology.

• Experience in managing global clinical studies across various countries and regions.

• Proven ability to proactively identify issues that may affect clinical programs and contribute effectively to solutions impacting cross-functional teams.

• An advanced degree (e.g., MS, PhD, PharmD) or equivalent experience is preferred.

• Demonstrated experience in leading projects within a matrix environment to develop clinical plans and manage change effectively.

• Capacity to work independently and proactively, taking on leadership roles in cross-functional study teams.

• Exceptional leadership, influencing, and negotiation skills.

• Ability to spearhead change, foster continuous improvement and learning, and build effective networks of partners and stakeholders.

• A minimum of 6+ years in a Clinical Trial Management role at a CRO or Pharmaceutical Organization is ideal.

• A Bachelor's degree in health, life sciences, or an advanced degree (e.g., MS, PhD, PharmD) is required.

• Ideally, at least 10+ years of relevant experience in clinical trial management is preferred.

• Experience managing complex or global trials is advantageous.

• Preferred: Experience overseeing all trial components from start-up to database lock.

• Preferred: Experience leading cross-functional teams, including oversight of external CROs.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage, where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.