Senior Associate, Study Start Up

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. 

Position

We are seeking an experienced and detail-oriented Senior Associate for Study Start-Up. In this role, you will collaborate with the Senior Director of Study Start-Up and clinical trial teams to enhance the operational efficiency and effectiveness of clinical trial execution, particularly during study and site start-up across all phases of Clinical Development. You will support Clinical Development Operations by ensuring the proper planning and timely execution of clinical trials, in line with established timelines and quality standards. Additionally, you will assist with site engagement activities, including Site Feasibility, Qualification, and Selection, and manage the distribution of the Study Start-Up Package and collection of Site Essential Documents, supporting IP shipment and Site Initiation Visit conduct.

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

What You’ll Do

• Support the Clinical Operation team in the successful execution of clinical trials, from protocol concept to Site Activation, complying with ICH / GCP / EMEA guidelines and regulations and SOPs.
• 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 investigator site identification through activation, forecasting and planning and contributes to accurate site activation deliverables.
• Engage and develop strong working relationships with clinical study teams (e.g., Clinical Operations, Clinical Supply, Legal and Regulatory) to generate the best outcomes for site start up activities.
• Working closely with SSU Managers to develop and send Site Outreach messages, track site responses and completion of Confidentiality Disclosure Agreements and Feasibility Questionnaires. 
• Ensure that selected sites are meeting or exceeding all site start up requirements leading to Site Activation.This includes working to create Site Specific Activation Plans with investigator sites to drive to competitive Site Start Up Timelines.
• Utilize Veeva Vault Clinical – CTMS, TMF, SSU Module and Site Connect to capture, manage and archive Country, Site and Person contact information and milestones that enable direct communications with sites and required forecasting for Site Activation.
• Utilize Veeva Vault Clinical Reports to ensure the completeness and accuracy of the Veeva Vault Clinical – CTMS/TMF/SSUm/SC datasets; assess the status of Site Activation related activities and determine if risks are surfacing and how to best mitigate the issues.
• 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.
• Proactively identify and implement best site start up practices, seeking continuous process improvement.

Qualifications

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• Understanding of US and global regulations and guidelines (e.g., FDA, EMEA, ICH) applicable to clinical development.
• Experience within the pharmaceutical industry or Clinical Research Organization (CRO) working with clinical development processes, specifically Site Start Up; Understanding of the complexities associated with study and site start up.
• Strong analytical and project management skills.
• Ability to rapidly adapt to changes in the work environment, manage competing demands and change approach or method to achieve optimal fit-for-purpose solution.
• Excellence in driving results. You persist in accomplishing objectives and exceeding goals despite obstacles and setbacks, while also helping others to achieve results.
• Excellent verbal / written communication and collaboration skills and ability to influence and build effective relationships in a matrix organization, including to ensure timely follow-up, issue resolution, and report updates.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (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/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $96,000 to $104,500 depending on skills, competency, and the market demand for your expertise.