Director, Clinical Trial Management
Job Location:
Jacksonville, FL - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
ABOUT ALIMENTIV
Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour operational excellence and deep therapeutic expertise including supporting more than 70% of IBD compounds in development.
We operate as a private profit-with-purpose company channeling our commercial success back into scientific research technology and our people. With approximately 700 people across multiple countries and three service lines we are growing deliberately and the capability of our leaders and our organization is central to how we get there.
If you want to do meaningful work build something real and invest back in research that changes lives we want to meet you.
THE OPPORTUNITY
This role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads) ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment the role supports operational excellence through effective planning resource management process improvement and a strong focus on quality and compliance.
Partnering closely with sponsors researchers and cross-functional project teams throughout the study lifecycle this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development overseeing site and compliance monitoring practices managing staff and contractor performance and ensuring teams including third-party providers consistently deliver timely high-quality service aligned with corporate standards industry best practices and global regulatory requirements.
- Working in conjunction with clinical monitoring and project leadership team members identify develop plan for monitor approve and/or report on project specific processes and services related to site selection clinical monitoring ICH-GCP compliance issue resolution and global project harmonization including SOP and QS document maintenance periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis.
- Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement to address sponsor/site concerns and to integrate new technologies and processes.
- Ensure regulatory compliance industry best practices and organizational goals and targets are met and/or exceeded.
- Manage members of the Clinical Monitoring teams ensuring functional areas are adequately staffed with qualified personnel providing ongoing support to staff in the areas of work allocation resource planning training and development technology process development expense management employee engagement and performance management (staff role development evaluations performance improvement and lost time management).
- Identify procure and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services including needs assessment recruitment contract negotiations Corporate and Sponsor policy compliance training and development cost monitoring and performance management ensuring corporate industry and regulatory service level guidelines and regulations are maintained.
- Provide expertise developing tools to support project teams and business development in the areas of clinical site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors.
- The successful candidate should have a College Diploma/University Degree in a relevant field (Health Sciences Life Sciences preferred or SoCRA and/or ACRP Certification/Designation) and a minimum of 4-6 years related experience substantial on-going training.
- Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting.
- Ability to work in a remote global capacity
- Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP.
- Team player that has a customer service approach and is solution oriented.
- Demonstrated leadership skills
- Strong verbal written and organizational skills.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Home-based
Required Experience:
Director
About Company
Accelerate your GI clinical trials with Alimentiv’s site network, clinical trial services, medical imaging, and biomarker discovery
