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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.
Minimum 8+ years of experience in clinical research, including experience in line management, team lead, or supervisory role within a CRO or pharmaceutical environment, with demonstrated competency and capability to manage and develop staff.
Depth of clinical trial experience as evidenced by work on wide range of trial phases and therapeutic areas.
Strong understanding of clinical trial execution, ICH-GCP guidelines and regional regulations.
Proven ability to lead, mentor, and develop high-performing teams.
Exceptional interpersonal and communication skills.
Ability to work with resource planning and performance management tools.
Expertise with clinical trial management systems (CTMS), Microsoft Office, and remote team collaboration platforms.
Fluency in oral and written English, with solid capability in writing medical and scientific materials or content.
Ability to work effectively in a fast-paced, matrixed environment.
Strong leadership, tactical and strategic thinking skills.
Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas.
Ability to accommodate working in a global environment and across time zones, as needed.
Experience at a small CRO is highly desirable.
Ability to travel as necessary, both domestic and international.
What we offer:
A dynamic and innovative workplace that embraces new ideas.
Work with new and exciting technologies.
Supportive colleagues that are driven by their passion for our mission.
Opportunities for accelerated career advancement as the team grows.
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