Director Clinical Operations
- Reporting to the Chief Medical Officer, leads individual clinical development programs
- Ensures the effective selection, initiation and motivation of clinical study sites
- Oversee patient recruitment and retention
- Ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol
- Takes the initiative to move the project/program forward and leads in country and global projects where applicable
- Is customer focused on both internal and external stakeholders
- Oversees the management of clinical vendors with focus on deliverables
- Supports Clinical Affairs in the development and review of the protocol/study design, case report forms, informed consent forms and other documents
- Ensure transparent and proactive communication regarding study progress and trial issues through use of dashboard, trackers and update communication tools
- Oversees the study managers development and approval of clinical study execution plans and tools including data capture instruments and the trial master file.
- Oversees study managers who drives the successful activation of trial sites according to time, quality/scope and budget parameters
- Serves as escalation point of contact for all clinical management and vendor management issues. • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
- Oversees integration of study mangers and Data Management vendor to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
- Escalates issues and provides first point of escalation path for study managers
- Performs any other duties required to ensure the success of the trial
- Forecasts and administers clinical development program budget and timelines
- Interfaces with KOLs and other external stakeholders (Advisory Boards) to provide input to study feasibility, study design including executability, and recruitment timelines.
- Oversees the identification, selection and qualification of all clinical vendors.
- MEDICAL DEVICE EXPERIENCE
- Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required.
- Read, write and speak fluent English
- 10-15+ years’ experience in clinical trial management
- Experience with complex trials
- Budget/finance experience on a project level and demonstrates a full understanding of project financials
- Understanding of either drug development or experience with device development strongly preferred
- Demonstrated track record of successfully supporting, developing and executing clinical development plans
- Proven ability to strategize prioritize and manage multiple projects simultaneously to ensure quality, timely, on-target accomplishment of tasks
- An ability to collaborate and communicate effectively internally and externally and to collaborate effectively with internal and external partners including the ability to work in matrixed environments including both company staff and consultants.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Pre Clinical Development
Clinical Trial Management Systems
Trial Master File
Case Report Forms
Clinical Study Design