Director Clinical Operations

TalentCraft; Yukon (OK); On-site; USD 120,000 - 180,000; Full time

Job summary

TalentCraft is seeking a Regional Director of Clinical Operations to oversee site performance, revenue generation, and quality of research across assigned regions. This leader will drive KPI attainment, ensure proper staffing, and coordinate with executives to mitigate business risks and report progress.

The role requires extensive experience in clinical research leadership, strong regulatory and project management skills, and the ability to collaborate with sponsors and investigators to meet

Qualifications

• Must have regulatory knowledge and project oversight experience.
• Experience coordinating clinical procedures and study start-up.
• Ability to interact with sponsors and manage sponsor expectations.
• Strong HR understanding for team leadership and staffing.
• Proven leadership and oversight in a clinical research setting.

Responsibilities

• Strategically track study start-up performance to protect revenue and timelines.
• Monitor site revenue production and provide feedback to hit revenue goals.
• Ensure sites meet recruitment targets and scheduling to optimize outcomes.
• Oversee staffing and training to ensure compliant conduct at sites.
• Ensure sites have equipment and resources for study activities.
• Supervise QC activities and coordinate with QA for audits/inspections.
• Coordinate with managers and PIs to ensure investigator coverage.
• Communicate and verify site goals with leadership and PIs.
• Report progress and risks to Executive Director/COO and mitigate risks.
• Address other duties as assigned.

Skills

Regulatory

Project Management

Clinical procedures

Sponsor interaction

Human Resources

Education

College or Specialized Degree

7-10 years’ experience in the Clinical Research Industry

Job description

The Regional Director of Clinical Operations is responsible for overseeing site performance, revenue generation, and quality of research conducted. The Regional Director of Clinical Operations is responsible for holding sites accountable to KPIs and revenue goals. The Regional Director is responsible assisting site in mitigating business risks and for reporting progress and risks to the Executive Director.

Job Description:

• Strategically track and assess study start up performance and provide feedback to ensure successful start-up for revenue production and future business
• Strategically assess site revenue production and provide feedback to meet revenue goals
• Hold sites accountable to adequate scheduling to meet/exceed recruitment and revenue goals
• Provide oversight of sites to ensure site is amply staffed and that staff are trained to meet study conduct requirements
• Provide oversight of sites to ensure the site is equipped for study conduct
• Provide oversight of sites are completing visits, edc, queries according to contractual terms
• Support sites as a resource for clinical research questions
• Ensure sites are conducting QC at site level and enlists the help of QA when needed for audits, inspections, or other QA needs
• Interact with managers and PIs to make sure sites have ample investigator coverage
• Communicate and verify site goals with manager and PI
• Report site performance progress and risks to Executive Director and/or COO
• Provide solutions for mitigating business risks
• Other duties as assigned

Reports to: Executive Director/COO

Required Skills/Abilities:

• Knowledge in the following areas:
• Regulatory
• Project Management
• Clinical procedures
• Sponsor interaction
• Human Resources

Education and Experience:

• College or Specialized Degree
• 7-10 years’ experience in the Clinical Research Industry
• 5+ years experience in supervisory/management role