Manager, Study Start Up

Eikon Therapeutics•Jersey City, NJ

2d•$130,000 - $157,500•Hybrid

About The Position

Eikon Therapeutics is seeking an experienced, collaborative, detail-oriented Manager, Study Start Up to improve operational excellence and efficiency in clinical trial study and site start up across all phases of Clinical Development. Working with the Senior Director, Study Start Up and clinical trial teams, this role drives study feasibility deliverables, provides data-driven recommendations to accelerate trials, and supports study planning to ensure timely execution in alignment with timelines and quality standards. The position requires onsite presence at least three days per week, or more as business needs require, at the Jersey City, New Jersey office.

Requirements

Postgraduate degree with at least 4 years of relevant experience, or a bachelor's degree with at least 6 years of relevant experience in life sciences, healthcare, or a related discipline.
Solid understanding of US and global regulations and guidelines applicable to clinical development, including FDA, EMEA, and ICH.
Significant experience in the pharmaceutical industry or a clinical research organization (CRO), working with clinical data and clinical development processes.
Deep understanding of study start up complexities.
Strong analytical and project management skills.
Ability to adapt to changing work environments, manage competing demands, and adjust approaches to find fit-for-purpose solutions.
Ability to persist in accomplishing objectives and exceeding goals despite obstacles and setbacks, while helping others achieve results.
Excellent verbal and written communication and collaboration skills, with the ability to influence and build effective relationships in a matrix organization and ensure timely follow-up, issue resolution, and report updates.
Experience with Veeva clinical solutions and familiarity with leveraging multiple technologies.

Responsibilities

Work with Clinical Development R&D functions to enhance analytics, inform study feasibility deliverables, and provide data-driven recommendations on study design and start up.
Build effective relationships with clinical study teams and cross-functional partners to achieve strong study and site start up outcomes.
Drive adherence to study start up planning and execution standards and country requirements, collaborating with Clinical Operations on site information management.
Partner with Clinical Operations and clinical trial teams to collect real-time information supporting country allocation, investigator site identification through activation, forecasting, planning, and site activation deliverables.
Support clinical trial execution from protocol concept through Site Activation in compliance with ICH, GCP, EMEA guidelines and regulations, and SOPs.
Monitor whether selected sites meet or exceed study start up requirements and gather metrics to measure performance against KPIs.
Develop site budgets and contracts as required, establish achievable finalization target dates, and support negotiations using fair market value (FMV).
Engage Legal and Finance as needed.
Collect and summarize study start up data and insights to help improve turnaround times.
Create, manage, and archive central start up team tools and resources, including investigator databases and clinical site intelligence, from study assignment through final handoff.
Identify and implement study start up best practices and continuously improve processes.
Facilitate study start up forum discussions.
Support development of local workflows to streamline output and deliverables.
Support Clinical Development Operations in fostering a partnering mindset.