Associate Director, Clinical Study Management, EMEA/LATAM
About The Position
The Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require onsite presence a minimum of 3 days a week to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.
Requirements
- Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a post graduate degree.
- Fluency in English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels) is required.
- In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevant regulations and guidelines.
- Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
- Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
- Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
- High sense of accountability and urgency in order to prioritize deliverables.
- Growth mindset and capable of working independently.
- Proven experience managing multi-center global clinical trials (Phases I–IV), with familiarity with regional nuances.
Nice To Haves
- ability to speak multiple EMEA/LATAM languages is a plus for this role.
Responsibilities
- Team leader and builder, who manages trial deliverables, timelines in assigned protocols across EMEA and LATAM to meet country commitments and regulatory requirements.
- Works with minimal oversight from Clinical Operations Senior Director or Director, in collaboration with Clinical Operations teams and Clinical Research and Development functional teams.
- Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.
- Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed in accordance with contract specifications of time, cost and quality ensuring compliance with applicable regulations, guidelines, and company policies.
- Work with finance, legal, external vendors and clinical sites to ensure the assigned studies are meeting the target milestones.
- Keep up to date with regional regulations, health authority frameworks, treatment landscape and country requirements.
- Manage regional resource planning, budgeting, forecasting, and key performance indicators (KPIs) for the region.
- Provide direction to cross-functional study teams to ensure successful study execution.
- Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research).
- Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
- Oversee and be in compliance with Eikon processes, SOPs, clinical supply and ancillary supplies management, import/export requirements, insurance supply management.
- Expected to lead, manage, hire regional Clinical Operations Study Management personnel across EMEA and LATAM, as required, to support operational excellence.
- Contribute to initiatives and projects adding value to Eikon Therapeutics.
Benefits
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
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What This Job Offers
Job Type
Full-time
Career Level
Director
