Associate Director, Study Start Up

Position Summary:

- Up, to define vision, goals, strategies and tactics to ensure delivery of study start-up activities per project plans across the portfolio.

The Associate Director will lead and a team of SSU managers to drive site activation delivery focused on quality, efficiency and expediency. This role is responsible for performance management of employees and contractors. This role will partner with Global Development Teams, Clinical Study Teams and also work with other internal external stakeholders, groups and vendors. This role will partner with targeted investigators to ensure accelerated start up strategies are leveraged at targeted and partner sites. This role will help teams identify risks to site activation and develop mitigation plans. This role is also accountable for resolution of site activation escalations for study teams including offering options for mitigation (both at the study and site level). This role is accountable for all study start-up activities, to ensure delivery of these activities per project plans.

Principal Responsibilities:

- Collaborates with peers and senior leaders within SSU to support resource planning, identify and hire and develop and retain talent.
- Direct people management of up to 10 employees and associated professional development.
- Manage flexible contract resources in collaboration with vendor partners.
- Works with assigned teams to define Global Start-Up Project Plans and ensure swift study start-up across the portfolio.
- Provide guidance and oversight to SSU managers to ensure quality and timely site start-up deliverables and ensure all systems are continuously updated and SSU documents filed.
- Facilitate collaboration with internal and external stakeholders including, Clinical Study Leaders, Feasibility Leads, Patient Recruitment and Retention, Regulatory, Clinical Monitoring, Clinical Finance, Compliance and Transactional Law.
- Relationship management with CRO and other vendors at portfolio level, defining and monitoring scope of work, developing governance plans and monitoring performance via metrics and KPI, invoice review and approval, issue escalation and resolution.
- Provide expert guidance on standards for quality compliance, implement and oversight plans and monitor to ensure inspection readiness.
- Ensure accelerated start-up for targeted investigators and build partnerships with clinical sites.
- Serve as a point of escalation for Study Start-Up team members in managing critical path activities, including evaluation of site budget and contract escalations.
- Represent Regional Clinical Trial Operations in cross-functional teams and committees.
- Develops SOPs and training guides applicable to a global organization.
- Identify improvements and efficiencies and share lessons learned broadly with key stakeholders
- Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations.

Qualifications:

- A minimum of 8 years of relevant clinical trial management experience
- A minimum of 5 years study start-up experience at a regional level
- Thorough understanding or clinical contracting and budget principles and process
- Demonstrated experience leading teams and working with cross functional teams
- Demonstrated people management experience
- Demonstrated experience with CRO oversight
- Oncology trial experience preferred, or experience with trials in similar disease states
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- English language fluency
- ** thorough understanding of local compliance, as well as a sound ethical approach to business**

**Education**:

- BA/BS or equivalent or any relevant and qualifying training. Advanced degree preferred.
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