Manager, Study Start Up

eikontherapeutics; Jersey City (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Eikon Therapeutics is seeking an experienced Manager, Study Start Up to optimize clinical trial initiation across phases. You will partner with Senior Director, Study Start Up and clinical teams to drive feasibility, planning, and data-driven decisions to accelerate trials.

This onsite role requires at least 3 days per week in Jersey City, NJ, and focuses on start-up efficiency, site activation, and regulatory compliance under ICH/GCP guidelines, with a collaborative, detail-oriented approach.

Qualifications

• Post Graduate degree with 4+ years of experience or a Bachelor's degree with 6+ years in life sciences, healthcare, or related discipline.
• Solid understanding of US and global regulations and guidelines (FDA, EMEA, ICH) applicable to clinical development.
• Significant experience within the pharmaceutical industry or CRO with clinical data and development processes.
• Deep understanding of complexities of study start up.
• Strong analytical and project management skills.

Responsibilities

• Enhance analytics with Clinical Development R&D to ensure the right questions are asked and data is leveraged to drive feasibility and accelerate trials.
• Engage and develop strong working relationships with clinical study teams to generate the best outcomes for start up activities.
• Drive adherence to standards for planning and execution of study start up and country requirements, coordinating with Clinical Operations on site information management.
• Partner with Clinical Operations to ensure real-time collection of information for country allocation, investigator site identification through activation, forecasting and planning.
• Support Clinical Operations in successful execution of trials from protocol concept to Site Activation, complying with ICH/GCP/EMEA guidelines and SOPs.

Skills

Analytical skills

Project management

Clinical operations

US FDA knowledge

Cross-functional collaboration

Education

Bachelor's degree

Postgraduate degree

Job description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

We are currently seeking an experienced, collaborative, detail oriented Manager, Study Start Up expert. In this role you will work with the Senior Director, Study Start Up and the clinical trial teams to improve operational excellence and efficiency of clinical trial execution in study and site start up across all phases of Clinical Development activities at Eikon Therapeutics by: Driving study feasibility deliverables and providing data driven recommendations to accelerate clinical trials and Supporting Clinical Development Operations Study Planning: to ensure proper planning and timely execution of all clinical trials in alignment with timelines and quality standards.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative and passionate about unlocking hidden insights in today's clinical operations landscape and relentless in your pursuit of operational excellence.

What You'll Do

• Working closely with Clinical Development R&D functions, enhance analytic capabilities to ensure the right questions are being asked and data is being leveraged to drive study feasibility deliverables and provide data driven recommendations to accelerate our clinical trials in study design and study start up.
• Engage and develop strong working relationships with clinical study teams (e.g., Clinical Operations, Clinical Supply, Legal, Regulatory, Clinical IT, Clinical R&D Process and Learning Management, Clinical Project and Portfolio Management, Clinical Quality Assurance, Clinical Data Management, and Clinical Research) to generate the best outcomes for study and site start up activities.
• Drive adherence to standards for planning and execution of study start up, country requirements, working in collaboration with Clinical Operations on site information management activities to ensure time critical and high-quality delivery of study specific needs.
• Partnering with Clinical Operations and clinical trial team, ensure the real time collection of information that informs country allocation, investigator site identification through activation, forecasting and planning and contributes to accurate site activation deliverables.
• Support the Clinical Operations team in the successful execution of clinical trials, from protocol concept to Site Activation, complying with ICH / GCP / EMEA guidelines and regulations and SOPs.
• Ensure that selected sites are meeting or exceeding all study start up requirements leading to Site Activation. This includes gathering and monitoring start up metrics to measure against KPIs.
• As required, develop site budgets & contracts, establish achievable finalization target dates and support the negotiations process leveraging FMV.
• Engage Legal and Finance as deemed necessary.
• Collect and summarize data and study start up insights for Clinical Operations and clinical trial team's consideration to improve Study Start Up turn around times.
• Create, manage and archive central start up team tools (e.g., investigator database, clinical site intelligence, etc.) and resources required to support start up team daily operations, communications and records from study assignment to final handoff.
• Proactively identify and implement best study start up practices, seeking continuous process improvement.
• Facilitate study start up forum discussions.
• Support in the development of local workflows to streamline output and deliverables.
• Support Clinical Development Operations in driving a partnering mindset.

Qualifications

• Post Graduate degree with 4+ years of experience or a Bachelor's degree with 6+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline). Solid understanding of US and global regulations and guidelines (e.g., FDA, EMEA, ICH) applicable to clinical development.
• Significant experience within the pharmaceutical industry or clinical research organization (CRO) working with clinical data and clinical development processes.
• Deep understanding of complexities of study start up.
• Strong analytical and project management skills.
• Able to rapidly adapt to changes in the work environment, manage competing demands and change approach or method to