Manager, Study Start Up

Eikon TherapeuticsJersey City, NJonsite$130k–$158kView the original posting at Eikon Therapeutics ↗

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 implem

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