Senior Director Study Start Up

Meet Life Sciences; Massachusetts; On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Director for Global Delivery in Life Sciences. This pivotal role involves leading the Study Start Up team, ensuring predictable delivery across clinical trials. You will collaborate with various internal teams to set and achieve study start-up targets while developing strategies to enhance operational capabilities. The ideal candidate will have extensive experience in global clinical operations, a strong track record in leadership, and the ability to drive performance through data-driven insights. Join a dynamic environment where your leadership can significantly impact clinical trial success.

Qualifications

• 15+ years in global clinical operations with 10+ years in management.
• Expertise in regulatory and site start-up requirements.

Responsibilities

• Lead the Study Start Up team ensuring consistent delivery.
• Collaborate with teams to define and deliver study milestones.
• Oversee end-to-end start-up process including site activation.

Skills

Project Management

Problem-Solving

Leadership

Communication

Data Analysis

Education

University degree in Science

Higher degree preferred

Tools

Clinical Trial Management Systems (CTMS)

Electronic Trial Master File (eTMF)

Job description

Direct message the job poster from Meet Life Sciences

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