Who we are:
Since 2015, we have been on mission to transform the way people find, choose, and participate in clinical research by building one of the largest integrated research organizations in the U.S and by creating our award winning technology TrialScout, the first ever patient rating and review platform for clinical trials. Our technology isn"t the only award winner! As a winner of the 2020 Best Places to Work contest by the Buffalo Business First periodical, we work hard to make sure our culture is focused around transparency, accountability, performance, and continuous learning - because just as we are obsessed with the patient experience in clinical trials, we are equally obsessed with the employee experience. We are looking to expand our growing team!
What we offer:
We are proud to offer competitive benefits, salary, and an environment focused on helping you grow personally and professionally.
What you"ll do:
As the Director of Clinical Site Operations, you will be responsible for directing all operational activities at our clinical sites in our expanding integrated research network. The research sites will be located in various districts across the Northeast with potential expansion into other territories and include multi-specialty therapeutic areas. You will have direct responsibility for operations and management related to clinical trials projects. You will work to identify and improve operational effectiveness and oversee workflows, processes, and procedures within the research sites. You will work closely with the Business Development, Regulatory Affairs, Legal, and Finance to meet goals and objectives for each project. You will provide leadership to the Clinical Group Services Lead and associated staff within each district.
You"ll be responsible to:
- Work collaboratively with the assigned project manager to complete timely site onboarding for new sites within the network, ensuring appropriate space, equipment, technology, and clinical personnel.
- Work in close collaboration with the Business Development to use data driven insight to match trials to each site.
- Work in close collaboration with Business Development to coordinate study related training for both internal staff and physician network staff including Principal Investigators
- Provide oversight or conduction of pre-site, site initiation, and close out visits with sponsor or CRO representative.
- Ensure each study is meeting revenue, patient enrollment, and patient engagement goals.
- Maintain the operational integrity of current research sites.
- Ensure adoption and optimization of our clinical trial technology systems.
- Work collaboratively to implement and maintain clinical specific process flows, policies, and procedures where needed.
- Provide direct managerial oversight to our district Clinical Services Group Leads and associated clinical research site staff, ensuring each member is meeting study specific and business related expectations.
Who you are:
- At your core, you are an orchestrator. You are able to understand a vision and thrive on directing, coordinating, organizing, and arranging the details to create a structure and framework around that vision.
- You are an excellent communicator, both verbally and written. You will need to clearly articulate the business and study needs to your direct reports as well as prepare and present status updates to leadership.
- You have a critical, but kind eye. You see gaps and work proactively to close them. You enjoy tightening up loose ends and improving inefficiencies.
- You are comfortable with delegation. You will need to provide a clear delegation of duties and expectations so that each site is running smoothly.
- You tend to be 10 steps ahead of the game and can anticipate needs before they happen. This comes at no loss to the current state and ability to complete daily tasks.
- This is likely because you like to ask questions. You understand the need to obtain drilled down details to have smooth operating success. You are able to live in those details without losing sight of the bigger picture and the end result. Nothing falls through the cracks on your watch.
- You are proactive. When problems arise, you think through them logically and with clarity and work to resolve them swiftly.
- You are collaborative and work well in a team environment.
- You have a growth mindset and embody our core value of continuous learning - you don"t take failures or mistakes as setbacks, instead asking what did I learn and how can I improve?
- You are results oriented and see projects through to the finish line without losing momentum
- You practice accountability - taking ownership for your work and results.
- You are readily transparent and share pertinent information in a timely manner.
- As a Director, you have an interest and passion for leadership. You work to motivate and guide your direct reports in a supportive manner, and equally challenge them to grow in their roles and responsibilities. You have a way of delivering constructive feedback in a clear, articulate, and helpful manner.
- Master"s degree preferred, Bachelor"s degree required in Life Sciences, Nursing, or Health related field
Your preferred experience:
- Clinical Research industry knowledge is a must to be successful in this role. A deep understanding of study conduction from startup to close, including regulatory requirements, is essential.
- At least 8-10 years of progressive leadership experience in Clinical Research or related industry.
- Detailed understanding of clinical studies site management.
- Demonstrated understanding of Phase I-IV clinical studies and all integrated lifecycle steps and associated organizational responsibilities.
- Demonstrated understanding of budgeting and resourcing.
- Proficiency with Microsoft, Google suite, and project management tools.
- CTMS experience is a plus.
- CRM experience is a plus.
Who you"ll report to:
- Reporting to our SVP of Operations, you will work closely with our Clinical Operations Group and work cross collaboratively with our Business Development and Regulatory groups.
The other fine print:
- Location: This position can be headquartered remotely, but with the travel requirements outlined below
- Travel: Will require regular travel between research sites presently located in the Northeast and periodic travel to our main campus located in Buffalo, NY
- Exemption status: Full time, exempt
- Physical requirements:the following physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
- Regularly required to sit, walk, and stand
- Regularly required to use hands; reach with hands and arms; talk and hear
- May occasionally lift and/or move up to 50 pounds
- Specific vision abilities required include close vision, distance vision and the ability to adjust focus
- Other duties: the duties and responsibilities described are not a comprehensive list and that additional tasks may be assigned to the employee from time to time; or. the scope of the job may change as necessitated by business demands