[All remote jobs](https://jobicy.com/jobs.md)Open role[![Alimentiv logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/d11f5845-221.png)](https://jobicy.com/company/alimentiv.md)Remote opportunity at[Alimentiv](https://jobicy.com/company/alimentiv.md) # Clinical Operations Lead Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/alimentiv.md)Share16 Aug 2026Published47Listing views2Application actions15 Sep 2026Apply before Opportunity details ## About this role. AI SummaryThis full-time, home-based Clinical Operations Lead role oversees regional clinical trial delivery, including CRA performance, investigator sites, monitoring quality, and compliance with protocols, ICH-GCP, and local regulations. The lead serves as the primary operational liaison between regional CRAs and the clinical project team, supporting study startup, enrollment, site performance, vendor activities, and issue escalation. Key deliverables include monitoring plans, training materials, site and CRA tools, visit-report review, protocol-deviation tracking, and corrective actions. Candidates need a life sciences, health sciences, or nursing background, significant related experience, at least three years of CRA experience, EDC proficiency, and strong written, verbal, and stakeholder-management capabilities. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThis is a senior clinical operations role requiring substantial clinical research experience, including at least three years as a CRA, plus strong command of ICH-GCP, monitoring, site performance, and study documentation. The lead must coordinate multiple stakeholders while maintaining quality, compliance, timelines, and escalation discipline across regional sites. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job medianMarket rate$115,000US market range$100k–$135k0$149k AI insightNo candidate compensation is disclosed in the posting. The figures below are estimated US-market annual base-salary benchmarks in USD for a mid-to-senior Clinical Operations Lead with CRA leadership, GCP compliance, site oversight, and project-delivery responsibilities; actual compensation may vary by employer, location, therapeutic area, and total-rewards structure. ## Core skills Skills and capabilities most closely associated with this opportunity. [Clinical Operations](https://jobicy.com/jobs?search_keywords=Clinical%20Operations.md)[Clinical Research](https://jobicy.com/jobs?search_keywords=Clinical%20Research.md)[CRA Leadership](https://jobicy.com/jobs?search_keywords=CRA%20Leadership.md)[ICH-GCP](https://jobicy.com/jobs?search_keywords=ICH-GCP.md)[Clinical Trial Monitoring](https://jobicy.com/jobs?search_keywords=Clinical%20Trial%20Monitoring.md)[Site Management](https://jobicy.com/jobs?search_keywords=Site%20Management.md)[Protocol Compliance](https://jobicy.com/jobs?search_keywords=Protocol%20Compliance.md)[EDC Systems](https://jobicy.com/jobs?search_keywords=EDC%20Systems.md)[Study Startup](https://jobicy.com/jobs?search_keywords=Study%20Startup.md)[Vendor Management](https://jobicy.com/jobs?search_keywords=Vendor%20Management.md) Cover letter sampleDear Hiring Team, I am excited to apply for the Clinical Operations Lead role. My clinical research operations experience includes CRA oversight, site management, monitoring-plan execution, and ensuring study delivery in line with ICH-GCP, protocol requirements, and local regulations. I bring a proactive, detail-oriented approach to managing regional performance, escalating risks, supporting enrollment strategies, and coaching CRAs to deliver high-quality monitoring outcomes. I would welcome the opportunity to support Alimentiv’s clinical project teams and investigator sites. Thank you for your consideration. Copy Sample interview questionsHow do you manage underperforming sites or CRAs while protecting study quality and timelines?I start by reviewing monitoring plans, protocol requirements, visit reports, enrollment metrics, data-query trends, and TMF completeness to identify risk early. I then set clear actions, owners, and due dates with the CRA and site, document the plan, and escalate material compliance or timeline risks to the project team promptly. Describe your approach to identifying and managing protocol deviations. I use ICH-GCP, the protocol, applicable local regulations, and documented evidence to assess the deviation and its impact on participant safety, data integrity, and study conduct. I ensure timely documentation, implement corrective and preventive actions, verify completion, and communicate significant issues through the appropriate escalation path. How would you train and mentor CRAs assigned to a new study? I establish a structured training plan covering the protocol, monitoring plan, EDC workflow, recruitment expectations, safety reporting, and country-specific requirements. I reinforce learning through regular CRA calls, co-monitoring or assessment visits, targeted follow-up, and documented completion of required training. Which metrics do you use to assess site and regional study performance? I track leading and lagging indicators such as enrollment against plan, activation timelines, monitoring visit timeliness, data-entry and query status, document collection, and TMF quality. I use these metrics to prioritize interventions and provide concise, actionable updates to the sponsor and clinical project team. How do you communicate a significant site-level risk to a study sponsor? I first confirm the facts, assess the operational and compliance impact, and align internally on the recommended path forward. I then provide the sponsor with a transparent status update, clear mitigation actions, responsible owners, expected dates, and an appropriate escalation route if the risk cannot be resolved at the working level. Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team. ### Project Oversight * Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines. * Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above. * May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for quality, compliance and appropriate site management. * Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan. * Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress. * Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review. * May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis. ### Project Liaison * Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls * Attend meetings with Study Sponsor to provide status updates on country and site progress * Provide operational support and guidance to the monitoring team throughout project. * Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented. * First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate. * Support line managers by providing status updates on utilization and performance of CRAs. * Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project. * Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities. ### Study Documents and Plans * Develop training materials and study tools for sites and CRAs, including monitoring plans. * Develop and implement enrolment and recruitment strategies together with clinical project team. * Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits. ### Qualifications * College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading OR * Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years’ experience + substantial on-going job-related training ### Other * Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation. * Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills. * Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized. * Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities. * Demonstrated ability in report writing and strong ability to critically understand clinical research documents. * Ability to handle multiple tasks to meet deadlines in a dynamic environment. ### Working Conditions * Home-based ### Compensation ### Additional Information Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@[alimentiv.com](http://alimentiv.com)”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. Show more [Apply now >](https://jobicy.com/jobs/150855-clinical-operations-lead.md) > Annual salary information is not provided for this position. 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