Senior Director Study Start Up (, MA, United States)

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Senior - Global Delivery - Life Sciences

The Senior Director, Study Start Up

Responsible for leading predictable and consistent delivery of study start-up across the Clinical Operations portfolio of clinical trials. Will head the Study Start Up (SSU) team while partnering with other Clinical Operations and Expertise Area leaders. He/she/they must be able to collaborate, influence, and lead discussions with key leaders/stakeholders to determine appropriate study start-up targets/milestones. Will provide strategic and operational leadership across clinical projects and contribute to defining the overall program strategy as it relates to study start-up.

Summary of Responsibilities:

• Lead and manage the Study Start Up (SSU) team within Clinical Operations, ensuring predictable and consistent delivery of study start-ups.
• Collaborate with internal teams (Clinical Operations, Regulatory, CROs) to define and deliver study start-up targets and milestones.
• Develop and implement strategies to enhance SSU capabilities, including site engagement, data-driven insights, and team skill-building.
• Provide leadership in the creation of frameworks, tools, and best practices to drive efficient country and site start-up.
• Oversee the end-to-end start-up process, including site selection, regulatory approvals, contract management, and site activation.
• Lead change initiatives, implement continuous improvement principles, and ensure adherence to quality, cost-effective clinical trials.
• Mentor and manage staff, promoting talent development and performance management.
• Provide data-driven insights, benchmarks, and KPIs to drive successful project execution and site activation.

Summary of Qualifications:

• University degree in Science or a related field (higher degree preferred).
• 15+ years of experience in global clinical operations, study start-up, or related fields, with 10+ years of line management experience.
• Proven track record of leading cross-functional teams, particularly in a CRO or biopharmaceutical setting.
• Expertise in global regulatory, site start-up requirements, and clinical trial management.
• Strong project management, problem-solving, and leadership skills.
• Ability to analyze data and make actionable decisions to improve performance.
• Excellent communication and interpersonal skills, with the ability to build relationships with stakeholders at all levels.
• Familiarity with clinical trial management systems (CTMS) and electronic trial master file (eTMF) systems.
• Willingness to travel up to 30% and manage remote teams.

Seniority level

Director

Employment type

Full-time

Job function

Strategy/Planning and Management

Industries

Pharmaceutical Manufacturing and Biotechnology Research