Director, Clinical Operations Study Start-Up

Overview:

The Director of Clinical Operations Study Start-Up will oversee the Study Start-Up portfolio managing Study Start-Up activities. This role takes direction from the Clinical Operations Leadership, will set the strategic direction for Study Start-Up planning and will provide oversight and leadership to drive the Study Start-Up activities. Furthermore, the Director, Site Contract and SSU will work collaboratively with all business partners to communicate decisions, issues, risks, and mitigations and will function as an SME to drive accelerated Start-Up timelines.

Roles and Responsibilities:

• Provide strategic and operational leadership for end‑to‑end study start‑up activities across assigned clinical programs, ensuring timely, compliant, and high‑quality site activation.
• Leads multiple programs to ensure investigative sites are activated in accordance with the timelines set for each study.
• Accountable for development, execution, and ongoing optimization of study‑specific start‑up strategies, including country selection, regulatory and ethics submissions, site feasibility and selection, contract and budget execution, and site activation readiness.
• Establish and maintain clear start‑up timelines, metrics, and dashboards; proactively identify risks to activation timelines and drive mitigation plans to achieve first site activation (FSI).
• Provide oversight of country‑ and site‑level regulatory and ethics submissions (e.g., IRB/EC/HA), ensuring consistency with global strategy and local regulatory requirements.
• Monitor vendor performance and participate in Vendor Governance as needed.
• Performs proactive risk assessment to anticipate study specific challenges and requirements and communicates in advance to the internal team to plan and mitigate risk.
• Analyzes projects through the collection, tracking and trending metrics and KPI assessments and guides internal and external teams to achieve industry leading results for study activation.
• Ensure quality, completeness, and inspection readiness of start‑up documentation, in accordance with GCP and internal SOPs.
• Partner with Clinical Research Organization(s) to oversee site contract and budget negotiations, ensuring alignment with approved study budgets and timely execution to support activation timelines.
• Serve as the primary escalation point for complex start‑up challenges, including site readiness or performance risks, regulatory delays, or vendor issues; communicate status and resolution plans to senior leadership.
• Contribute to portfolio‑level planning by providing start‑up insights and recommendations to inform study design, country strategy, resourcing, and feasibility assumptions.
• Develop and maintain study start‑up processes, systems, and tools to reduce cycle times, improve quality, and enhance predictability of start‑up delivery.
• Ensure start‑up activities are conducted in compliance with global regulations, internal policies, and company quality standards, maintaining a strong focus on patient safety and data integrity.
• Support organizational readiness for audits and inspections related to study start‑up activities, partnering with Quality Assurance as needed.
• People management and development responsibilities, and may have financial accountabilities for assigned staff.
• Contribute to process improvement, development of SOPs and study start up documents.

Experience, Education and Specialized Knowledge and Skills

• Minimum BA/BS degree or relevant graduate degree highly preferred
• Requires minimum of 15+ years of experience in the biotech/pharmaceutical industry with direct experience in feasibility, study start-up, site activation for global Phase 3 clinical trials, development of Master and country level ICFs, site payments, eTMF, CTMS, vendor oversight, and inspection readiness with a strong understanding of global regulatory requirements and clinical operations, and with over 5 years of supervisory/management experience.
• Proven track record in process improvement, clinical trial execution, and operational strategy.
• Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
• Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
• Strong organizational and project management skills, with a deep understanding of regulatory and submission processes in various countries, with ability to oversee multiple studies and priorities, simultaneously.
• In-depth understanding of relevant Clinical Research, Feasibility, Study Start-Up processes and clinical operations
• Solid working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and extensive experience with investigative site Start-Up documents
• Proven track record of managing multiple projects and/or programs concurrently.
• Excellent analytical, problem-solving, and organizational skills.
• Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
• Demonstrated ability to lead changes and foster a culture of continuous improvement.