Offer summary

Qualifications:

Bachelor’s degree in life sciences or a related field; advanced degree preferred., 6+ years of experience in clinical operations with progressive responsibility., Prior experience managing global or regional clinical trials in a CRO or sponsor environment., Deep understanding of ICH GCP, FDA/EMA regulatory requirements, and clinical trial lifecycle..

Key responsabilities:

Lead clinical trial execution from planning through close-out, ensuring milestones are met on time.

Oversee site feasibility, selection, start-up, monitoring, and close-out in collaboration with CRAs and CTLs.

Serve as the primary point of contact for Clinical Operations across internal teams and external stakeholders.

Support onboarding and mentoring of junior team members and contribute to process improvement initiatives.

Job description

Position Summary

The Clinical Operations Manager (COM) is responsible for the strategic oversight and operational delivery of clinical trials within a defined program or portfolio. The COM leads cross-functional teams, manages vendor and site performance, ensures compliance with timelines, quality, and budget, and serves as a key point of contact for internal and external stakeholders. This role is critical in driving excellence across study execution and ensuring alignment with corporate goals, regulatory standards, and ICH GCP guidelines.

Key Responsibilities

Study Oversight & Execution

Lead clinical trial execution from planning through close-out, ensuring milestones are met on time and within scope.
Oversee site feasibility, selection, start-up, monitoring, and close-out in collaboration with CRAs and CTLs.
Coordinate and lead study team meetings, track action items, and drive issue resolution.
Monitor study progress via metrics, KPIs, and risk indicators; initiate mitigation strategies when necessary.

Cross-Functional Collaboration

Serve as the primary point of contact for Clinical Operations across internal teams (e.g., Regulatory, Data Management, Safety, Medical Affairs).
Collaborate closely with Project Managers, Clinical Trial Leads, and functional leads to align study goals and resourcing needs.
Interface with sponsor stakeholders (if CRO-based) or vendor partners (if sponsor-based) to ensure alignment and transparency.

Vendor & Site Management

Oversee vendor deliverables (e.g., CRO, labs, imaging, ePRO), ensuring contract adherence and performance management.
Track site performance metrics, enrollment, and quality trends; contribute to decisions on site actions or replacements.
Support resolution of protocol deviations, audit findings, and quality issues.

People & Process Leadership

Support onboarding and mentoring of junior team members.
Contribute to process improvement initiatives and development of clinical SOPs, templates, and tools.
Foster a culture of quality, accountability, and proactive problem-solving within Clinical Operations.

Qualifications

Education & Experience

Bachelor’s degree in life sciences or a related field; advanced degree (MS, MPH, PharmD) preferred.
6+ years of experience in clinical operations, with progressive responsibility.
Prior experience managing global or regional clinical trials in a CRO or sponsor environment.
Deep understanding of ICH GCP, FDA/EMA regulatory requirements, and clinical trial lifecycle.

Skills & Competencies

Strong organizational and leadership skills, with the ability to manage multiple priorities and drive decision-making.
Excellent communication and interpersonal skills to engage with diverse stakeholders.
Proficiency in EDC, CTMS, eTMF, and remote monitoring tools (e.g., Medidata, Veeva, etc.).
Analytical mindset with the ability to interpret metrics and identify trends.

Travel Requirements