Clinical Operations Manager
Who we are?
Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
THE ROLE
The Clinical Operations Manager (COM) leads and supports the clinical operations team. The primary function of the role is line management of clinical operations staff including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), Clinical Trial Assistants (CTAs) as applicable, and other relevant team members. This role drives team performance, development, and operational excellence. This is a leadership position focused on people management, team optimization, and resource allocation across clinical projects.
This role is home-based in Europe.
Key responsibilities
- Provide day-to-day line management, mentorship, and performance oversight for assigned clinical operations staff.
- Conduct regular 1:1s, performance evaluations, and career development planning for team members.
- Oversee onboarding, training, and ongoing development to ensure staff proficiency and compliance with GCP, SOPs, and regulatory standards.
- Collaborate with Project Managers and Functional Leads to allocate resources effectively across multiple clinical studies.
- Monitor workload, performance metrics, and utilization to ensure efficient and quality of project delivery.
- Foster a positive and collaborative team culture focused on quality, accountability, and continuous improvement.
- Proactively works to ensure staff retention and turnover rates remain within expected levels.
- Serve as an escalation point for staff-related issues, supporting resolution in collaboration with HR and senior leadership.
- Contribute to the development, implementation, and refinement of clinical operations processes and SOPs.
- Support recruitment and hiring and workforce planning initiatives as the organization grows.
- Ensure that staff are appropriately trained and up to date on sponsor and protocol-specific requirements.
- Ensure all staff follow required training and complete the required documentation.
- Conducting accompanied CRA visits and reviewing CRA outputs specifically visit reports, visit confirmation and follow up letters, action item follow up and TMF completeness.
- Manage resource availability for clinical operations team.
- Work closely with other departments to ensure quality performance on all studies as well as to correct process deficiencies as identified by staff, clients, and auditors.
- Drive work groups and cross departmental collaboration to support the development of corporate best practices and processes.
- Provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required.
- Interpreting project budgets and timesheets for CRAs to support their understanding of time per task
- Representing Clinical Operations at client audits
- Attending client meetings to support project teams
- Attending internal project meetings to understand upcoming project deliverables impacting clinical operations as required
- Facilitating delivery of CRA monthly meeting content and training sessions
Qualifications and attributes
- Bachelor's degree (or higher preferred) in Life Sciences, Nursing, or a related field.
- Min