Clinipace is hiring a Director, Clinical Monitoring to provide strategic leadership and drive growth for the regional Clinical Monitoring function. In this role, you will be integral to Clinical Operations, responsible for the delivery of quality services, the development of your team, and supporting business development activities.
What You'll Do
- Provide guidance and oversight to the regional Clinical Monitoring team to ensure adherence to project scope, SOPs, timelines, and budgets.
- Identify and manage regional monitoring resources, overseeing CRA and CTM utilization and performance metrics.
- Ensure CRAs and CTMs achieve benchmark targets for trip report compliance and manage monitoring backlogs.
- Conduct weekly reviews of time and expenses.
- Provide support for the remote monitoring program.
- Support hiring initiatives by screening and interviewing potential new CRAs and CTMs.
- Develop new hire training materials and oversee the onboarding process.
- Collaborate with project management on field team structuring and efficient resource assignment.
- Assist project teams with monitoring services as required, including visits and report reviews.
- Oversee regional training, quality initiatives, and metrics for consistent service delivery.
- Drive departmental training and development for Clinical Operations Managers, CRAs, and CTMs.
- Provide performance feedback, conduct reviews, and develop corrective action plans for team members.
- Ensure regional compliance with SOPs, ICH/GCP, and regulatory requirements.
- Assure timely submission of clinical project metrics for the region.
- Develop, identify, and revise work processes and tools in collaboration with global counterparts.
- Provide leadership on company-level initiatives and represent departmental needs.
- Participate in regular Project, Business Development, Finance, and Strategic Development meetings.
- Assist in developing RFPs and budgets, participate in conferences, and contribute to business development strategy.
- Provide work direction and carry out supervisory responsibilities for CRAs and CTMs.
What We're Looking For
- BA/BS degree or equivalent relevant experience.
- 5 to 7 years of CRO or Sponsor experience in healthcare product development.
- 3 to 5 years of CRO management experience.
- Direct monitoring experience is required.
- Extensive knowledge of clinical research.
- Business management and quality process skills.
- Knowledge of field organizational strategies.
- Ability to adapt to a rapidly changing work environment.
- Demonstrated ability to make decisions critical to staffing, quality, and resource allocation.
- Experience managing a large number of direct and indirect reports or large teams.
- Strong Business Development presentation and sales skills.
- Demonstrated experience leading and facilitating.
- Successful management skills and positive leadership.
- Ability to speak to a group in a training environment and deliver feedback effectively.
- Practices professionalism and integrity in all actions.
- Ability to develop, mentor, and lead people and teams.
- Creative, acts as a change agent pursuing positive improvements.
- Effective as both a team member and team leader.
- Ability to work remotely.
- Ability to travel up to 30%.
Nice to Have
- An advanced degree.
- A health or science-related degree.
- Clinical coordinator experience.
Team & Environment
You will provide work direction and oversight to Clinical Research Associates (CRAs) and Clinical Trial Managers (CTMs).
Work Mode
This is a remote position.





