[Remote] Director, Clinical Trial Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global CRO focused on advancing therapies for gastrointestinal diseases. The Director of Clinical Trial Management is responsible for the leadership and operational reputed company of the Clinical Monitoring unit, ensuring high-quality clinical trial execution and compliance across global studies.
Responsibilities
- Working in conjunction with clinical monitoring and project leadership team members, identify, reputed company, plan for, monitor, approve and/or report on project specific processes and services reputed company 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 reputed company
- 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 reputed company 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) reputed company 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
- reputed company 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
Skills
- College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation)
- Minimum of 4-6 years reputed company experience + substantial on-going training
- Experience in managing CRA staff and ability to reputed company training and/or mentorship to colleagues on a 1:1 reputed company or meeting setting
- Ability to work in a remote global reputed company
- 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
Company Overview