Manager, Study Start Up

Eikon Therapeutics•Jersey City, NJ

1d•Hybrid

About The Position

Eikon Therapeutics is seeking an experienced, collaborative, detail-oriented Manager, Study Start Up to improve the operational excellence and efficiency of clinical trial execution across study and site start up for 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 clinical trials, and supports Clinical Development Operations study planning to help ensure trials are planned and executed on time and to quality standards. The role partners with Clinical Development R&D functions and cross-functional clinical study teams to enhance analytic capabilities, apply clinical operations data, and support study design and start up. Responsibilities span planning and execution from protocol concept through Site Activation, including country allocation, site identification, start-up requirements, metrics, budgets and contracts, and operational tools and processes. The position requires at least three days per week onsite, 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 clinical development regulations and guidelines, including FDA, EMEA, and ICH.
Significant pharmaceutical industry or CRO experience working with clinical data and clinical development processes.
Deep understanding of study start-up complexities.
Strong analytical and project management skills.
Ability to adapt quickly to changing work environments, manage competing demands, and adjust approaches to find fit-for-purpose solutions.
Ability to drive results, persist through obstacles and setbacks, exceed goals, and help others achieve results.
Excellent verbal and written communication and collaboration skills, including 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 analytic capabilities and use data to drive study feasibility deliverables and recommendations for study design and start up.
Build strong working relationships with cross-functional clinical study teams to support effective 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 for country allocation, investigator site identification through activation, forecasting, planning, and site activation deliverables.
Support clinical trial execution from protocol concept to Site Activation in compliance with ICH, GCP, EMEA guidelines and regulations, and SOPs.
Ensure selected sites meet or exceed study start-up requirements for Site Activation, and gather and monitor start-up metrics against KPIs.
As required, develop site budgets and contracts, establish achievable finalization target dates, and support negotiations using fair market value (FMV); engage Legal and Finance as appropriate.
Collect and summarize data and study start-up insights for Clinical Operations and clinical trial teams to improve study start-up turnaround times.
Create, manage, and archive central start-up team tools and resources, such as investigator databases and clinical site intelligence, to support daily operations, communications, and records from study assignment to final handoff.
Identify and implement study start-up best practices and continuous process improvements.
Facilitate study start-up forum discussions and support development of local workflows to streamline outputs and deliverables.
Support Clinical Development Operations in fostering a partnering mindset.

Benefits

401(k) plan with company matching.
Medical insurance, with premiums covered by Eikon at 95%.
Dental and vision insurance, with 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 and AD&D insurance, with premiums covered by Eikon at 100%, and optional supplemental employee-paid life and AD&D policies.
Enhanced parental leave benefit.
Daily subsidized lunch program when onsite.
Bonus and equity compensation.