Sr Manager, Clinical EP

Senior Manager, Clinical EP

San Antonio, TX

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for a Senior Manager to join the Clinical Early Phase team in San Antonio, TX.

This is an onsite, in-clinic role overseeing clinical execution of research studies. In this role, you will work closely with the Director, Clinical Operations to develop operational strategy ensuring execution of clinical studies in adherence to GCP/ICH, SOPs, FDA guidelines. The Senior Manager will have the responsibility of managing direct reports and supporting management of the extended reporting line and will represent Clinical Operations in cross functional initiatives.

The role

• Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes thereby adding value to our business and ability to meet client needs.
• Supervise and oversee performance of licensed and un-licensed staff, providing expert operational oversight and guidance to support clinic activities.
• Ensure the clinical operations team is properly trained in accordance with ICON SOPs and study protocols.
• Ensure quality and adherence to SOPs and Work Instructions and compliance with federal and local regulations.
• Identify and develop trainings as necessary for improvement of team performance, driving innovation in all areas of responsibility.
• Work collaboratively with cross-functional internal and external teams for the successful completion of clinical trials.
• Identify any gaps in process or procedures and develop solutions as needed.
• Provide oversight of resourcing of all staff in reporting line.
• Ensure Investigator directives are carried out in regards to direct or indirect volunteer care.
• Assist Investigators as necessary in the performance of procedures such as delivery of injections, infusions or oral dosing, collection of specimens or other study related tasks for which trained and delegated.
• Assist study teams in the development and review of study documents, e.g. draft protocols, draft CRFs, study manuals and procedural timelines.
• Participate in business development activities as necessary (operational calls, site visits, bid defense, etc).
  

What you need

• Preferred education/licensure: RN, MSN, Paramedic or similar extensive experience may be substituted for education
• Minimum 5 years' experience in a clinical research setting with 5 or more years management experience
• Knowledge of ICH/GCP and FDA guidelines

Why join us?

Ongoing development is vital to us, and as a Project Manager, Labs you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

Benefits of working at ICON:

We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies. ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin