Director, Site Start Up
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Director leading site start-up operations for Precision for Medicine, a global precision medicine clinical research services organization. Overseeing SSU delivery, regulatory submissions, contracts, complex programs, team development, and continuous improvement.
Responsibilities:
- Provide leadership, guidance, and overall support to the Site Start-up team across delivery, communication, human resources, revenue enhancement, procedures, systems, and processes
- Manage site start-up delivery through direct management and/or cross-functional oversight of IRB/EC submissions, Competent Authorities submissions, site contracts, budget negotiations, and other start-up requirements
- Establish the SSU framework with the Head of Site Start Up, including intelligence, tools, methodology, risk evaluations, and mitigations
- Collaborate with Clinical Operations, project management, and other functions on global and regional SSU planning, execution, and governance
- Support corporate and departmental business strategies
- Lead change management for the evolution and expansion of the global structure
- Provide leadership and oversight for large or increasingly complex SSU programs
- Manage escalations and remediation of SSU concerns
- Optimize processes and delivery to meet or exceed budget targets
- Partner with Global Resourcing on assessment and management of SSU leads, specialists, and Site Contract Management staff
- Support team career development, growth, succession planning, and compliance with company policies and regulatory guidelines
- Coordinate SSU Lead participation in client meetings and presentations
- Collaborate with Business Development on opportunities, proposals, budgeting, and bid defenses
- Work with global and regional functional leaders to support SSU project strategy and delivery
- Support SSU evaluations and implement required project changes
- Develop, measure, and report SSU KPIs and lead continuous improvement
- Reinforce company culture and values to motivate, engage, and retain the SSU team
Requirements:
- Bachelor's degree in life sciences or a related field, or equivalent combination of education, training, and experience
- Minimum 12 years of experience in clinical research, including extensive Site Start-up experience
- Experience working for a Clinical Research Organisation (CRO)
- Experience in people management
- Expert knowledge of GCP/ICH guidelines and the clinical development process
- Demonstrated leadership track record
- Experience working in a team environment with resource management experience
- Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint
- Clinical software experience, including CTMS, eTMF, and EDC
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail, and customer service demeanor
- Proven experience in strategic planning, risk management, and change management
- Fluency in English
Similar Jobs
Director of Infrastructure
Director of Infrastructure leading enterprise networks, cloud, security, and resilience for Enghouse, a publicly traded Canadian software and communications company. Aligning technology strategy, governance, budgets, and modernization with business growth.
Senior Director
Delivery Director leading Singapore-based operations and multiple projects for Centific, a technology services company. Managing budgets, hiring, project issues, and regional delivery innovation.
Senior Director, Order To Cash
Senior Director leading Order-to-Cash operations for Warner Music Group, a global music and publishing company. Managing billing, collections, revenue recognition, cash application, and regional OTC teams.
Senior Director, Omnichannel Experience Solutions – Pharma Ad Agency Experience Required
Senior Director leading omnichannel digital products and solutions for EVERSANA INTOUCH, a life sciences marketing agency. Driving strategy, Agile delivery, client engagement, and cross-functional program execution.
Director, Technology Applications – CPG & S&OP
Technology applications director leading CPG and supply-chain systems for Green Thumb, a cannabis company. Overseeing enterprise applications, IT operations, roadmaps, vendors, budgets, and complex projects.
Director, Site Start Up
Director leading site start-up operations for Precision for Medicine, a global clinical research services organization. Overseeing SSU strategy, delivery, compliance, teams, and continuous improvement across European markets.
Director, Site Start Up
Director leading site start-up for Precision for Medicine, a precision clinical research services organization. Overseeing SSU delivery, regulatory submissions, contracts, teams, risk management and continuous improvement.
Director, Site Start-up
Director leading site start-up for Precision for Medicine, a precision medicine clinical research services organization. Overseeing global SSU delivery, regulatory submissions, contracts, budgets and team development.
Director, Site Start Up
Director leading site start-up delivery for Precision for Medicine, a precision medicine clinical research services organization. Overseeing SSU teams, regulatory submissions, contracts, KPIs, risk management, and global clinical trial execution.
Director, Site Start Up
Director leading site start-up for Precision for Medicine, a global precision medicine clinical research services organization. Overseeing SSU delivery, regulatory submissions, contracts, teams, KPIs and continuous improvement.
Director, Total Rewards and Analytics
Total Rewards leader building compensation, benefits, and analytics infrastructure for Awayday’s U.S. hospitality and vacation rental platform. Partnering with executives and PE sponsors across 50+ brands.
Director, Coding
Director leading coding, auditing, and compliance for Axia Women’s Health, a multi-state women’s healthcare network. Optimizing physician billing, revenue cycle performance, provider education, and coding operations.
Director, Spatial Data Management
Director leading spatial data governance and workplace technology enablement for Cushman & Wakefield’s real estate services practice. Improving occupancy insights, standards, systems, and scalable client delivery across U.S. and Canadian operations.
Director of TikTok Shop
Ecommerce Operations Assistant supporting AUGO’s Amazon, Shopify, and TikTok Shop growth. Managing listings, customer service, pricing, content, reporting, and sourcing across international marketplaces.
Director, Global Oncology Patient Advocacy
Director shaping global oncology patient advocacy for Immatics, a PRAME-focused cancer immunotherapy company. Embedding patient insights across clinical development, commercialization, partnerships, and access initiatives.
Director, Site Start-up
Director leading site start-up delivery for Precision for Medicine, a global precision medicine clinical research services organization. Overseeing SSU teams, regulatory submissions, contracts, budgets, compliance, and continuous improvement across European markets.
Director, Site Start Up
Director leading Site Start-up for Precision for Medicine, a global precision clinical research services organization. Managing SSU delivery, regulatory submissions, contracts, teams, risks, KPIs, and continuous improvement.
Managing Director, Discovery and Insight
Managing Director leading TED Audacious Project’s global search, diligence, and selection of ambitious nonprofit ideas. Building philanthropic networks, rigorous finalist recommendations, and a high-performing discovery team.
Regional Planned Giving Director
Regional Planned Giving Director for The Salvation Army, cultivating and managing planned gifts in Western Texas. Building relationships with donors and collaborating on charitable estate planning with a focus on fundraising.
Regional Planned Giving Director
Regional Planned Giving Director responsible for securing planned gifts to support The Salvation Army's mission. Cultivating donor relationships and managing personal visits across Southern Florida.