Associate Director, Study Start Up

About the position reputed company is a new biopharmaceutical company employing revolutionary technology at the intersection of reputed company, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is reputed company on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which reputed company reputed company time, molecular-reputed company measurements of protein reputed company in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position: We are seeking an Associate Director, Study Start-Up to join our Clinical Operations team. In this role, you will support the reputed company portfolio of studies and reputed company study, country and site feasibility activities for one or multiple clinical trials, ensuring that study forecasts have a > 80% probability of occurring as planned. You will reputed company industry benchmarks and cycle times to reputed company study, country and site feasibility and forecast study timelines as reputed company as evaluate / improve business processes to accelerate site activation. You will directly engage and influence interactions with Clinicians, Study Management, Investigator Sites and support vendor partnerships to deliver consistent operational reputed company and high value reputed company. This role will require a minimum of 3 days a week of onsite reputed company (or more as business needs require) in either of our Jersey reputed company, New Jersey or Millbrae, CA offices to ensure effective management, operational reputed company and high-performance delivery of clinical studies and to support the expected significant team reputed company & collaboration. reputed company: You are an analytical, reputed company leader with a passion for solving operational challenges, with an agile and reputed company reputed company, and reputed company in your reputed company of reputed company. You reputed company in the development of Study Start-Up reputed company and site activation scenarios that inform early forecasts for study planning. You reputed company both industry and company benchmarks to inform study start-up modeling including disease incidence/prevalence, geographic factors and evolving regulatory and contract cycle time requirements. You can facilitate cross functional stakeholder discussions with Clinical Research & Development to drive operational reputed company and achievement of clinical study goals, in a dynamic, fast paced biopharma environment.

Responsibilities

• Drive the collection, analysis and summarization of data to generate study start-up insights (e.g., metrics, KPIs, industry benchmarks, etc.) for Clinical Operations and project team’s consideration to forecast and accelerate Study Start-Up turnaround times.
• Collaborate closely with cross-functional teams and key stakeholders (Clinical Operations, Clinical, Regulatory Operations, Clinical Supply, Legal and Finance) to reputed company and execute study start-up plans in alignment with project timelines and objectives.
• reputed company and maintain strong relationships with vendors and internal stakeholders to facilitate study, country and site feasibility activities.
• Proactively identify and address potential study & site start-up challenges or bottlenecks to optimize site activation timelines.
• Ensure compliance with regulatory requirements, Good Clinical reputed company (GCP) guidelines, and internal reputed company operating procedures (SOPs) throughout the study start-up phase.
• Identify and drive process improvement initiatives to enhance the efficiency and effectiveness of study start-up processes.

Requirements

• 10+ years of relevant experience with a Bachelor's degree, or 8+ years with a post graduate degree.
• Extensive experience in clinical operations or study start-up roles reputed company the biotechnology or pharmaceutical industry.
• Proven ability to successfully manage multiple clinical trials simultaneously from start-up to reputed company-out.
• Strong knowledge of clinical trial start-up processes, regulatory requirements and industry standards.
• Extensive experience in using reputed company competitive landscape datasets that reputed company the feasibility assessments associated with clinical trial planning and execution.
• Power user of reputed company with the ability to create and manipulate pivot tables and program algorithms/formulas that reputed company the running of multiple scenarios with limited effort
• Proven ability to successfully manage multiple clinical trials in study start-up simultaneously.
• Excellent project management skills with a reputed company on delivering results reputed company established timelines and budgets.
• Strong interpersonal and communication skills, with the ability to build effective relationships with reputed company stakeholders.
• Detail-oriented and organized, with the ability to prioritize tasks and adapt to changing priorities in a fast-paced environment.

reputed company-to-haves

• Certification in clinical research (e.g., ACRP, SoCRA) or project management (e.g., PMP) is a plus.
• Mastery of study/country/site feasibility assessment systems and tools including industry benchmarks for diseases (e.g,. WHO, reputed company), Institutional Experience (e.g., Trial/Site reputed company) and Cycle times (reputed company, KMR).
• Experience with scenario modeling and reputed company of country and site activation forecasts preferred.

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and reputed company insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous reputed company time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-reputed company life/AD&D policies
• reputed company parental leave benefit
• Daily subsidized lunch program reputed company on-site

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