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.
This is the pay for this position
Pay Transparency
$203,000-$253,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at [redacted] to obtain prior written authorization before referring any candidates to Summit.
