Manager, Feasibility and Site Activation (FSA) leading teams responsible for delivering high-quality feasibility assessments and efficient site activation for global clinical trials.
Compensation
Competitive base salary and performance related incentives
Responsibilities
Managing FSA project teams to deliver country and site feasibility, start-up strategies, and activation activities in line with timelines and quality expectations
Overseeing the coordination of essential documents, regulatory and ethics submissions, and contract/start-up packages for assigned studies
Reviewing feasibility data, assumptions, and risks, and partnering with stakeholders to develop mitigation plans and realistic start-up forecasts
Collaborating with business development and operational teams to support proposals, bid defences, and customer meetings with robust FSA input
Monitoring performance metrics for feasibility and site activation, identifying trends and driving continuous improvement initiatives
Requirements
Bachelor's degree in life sciences, healthcare, business, or a related field
Lead end-to-end delivery of complex clinical study programs for pharmaceutical/biotech clients, serving as the primary client contact and ensuring compliance with regulatory and quality standards.
Compensation
The salary range estimated for this position based in Maryland is $75,000.00–$112,500.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Responsibilities
Lead and manage full lifecycle clinical trial projects (start-up, conduct, close-out) for pharmaceutical/biotech clients
Act as the primary client-facing point of contact, building strong, consultative relationships
Drive study timelines, deliverables, and budgets while ensuring adherence to GCP, FDA, and ICH guidelines
Oversee cross-functional teams (clinical operations, labs, data management, supply chain, etc.) in a matrix environment
Proactively identify risks, develop mitigation strategies, and escalate issues appropriately
Requirements
High school diploma or GED required
Bachelor’s degree preferred (Life Sciences or Project Management preferred; e.g., Biology, Chemistry, Clinical Research, or related field)
Nice to have: PMP certification or equivalent
Nice to have: experience in a central lab, biomarker, or clinical services environment
Nice to have: prior experience in a client-facing or sponsor-facing role
Support ongoing clinical development programs within Rare Diseases, focusing on Pediatric Growth Hormone Deficiency and related endocrine disorders, acting as a field-based liaison to clinical trial sites, investigators, and stakeholders.
Locations (2)
Argentina
Colombia
Compensation
Amplity offers a competitive salary, comprehensive benefits package, and opportunities for long-term professional growth.
Responsibilities
Serve as a scientific and operational liaison between clinical trial sites and study teams
Support study start-up, site activation, patient recruitment, enrollment, and retention activities
Build and maintain strong relationships with investigators, study coordinators, referral centers, and research staff
Support sites in identifying and addressing recruitment barriers and enrollment challenges
Assist sites with patient identification strategies and referral pathway development
Lead clinical operations oversight for regional and global trials, ensuring compliance and quality delivery across monitoring and site management activities.
Responsibilities
Provide regional and/or global clinical operations oversight across assigned studies
Lead and oversee Clinical Operations Leads and CRAs, providing guidance, training, mentoring and operational support
Oversee key monitoring and site management deliverables, including visit schedules, reports, recruitment progress, and compliance
Lead and support country and site feasibility, selection and start-up activities
Serve as liaison between monitoring team, project management, cross-functional teams and sponsors
The Senior Clinical Operations Lead (Sr COL) provides clinical operations leadership and oversight for regional and global clinical trials, ensuring high-quality delivery across monitoring and site management activities.
Responsibilities
Provide regional and/or global clinical operations oversight across assigned studies, ensuring compliance with study protocols, Monitoring Plans, ICH-GCP, applicable regulations and project timelines.
Lead and oversee Clinical Operations Leads (COLs) and CRAs, providing study-specific guidance, training, mentoring and operational support throughout the project lifecycle.
Oversee key monitoring and site management deliverables, including monitoring visit schedules and reports, recruitment progress, essential document collection, protocol deviations and compliance with the Monitoring Plan.
Lead and support country and site feasibility, selection and start-up activities, providing Monitoring & Site Management input into country and site strategies.
Serve as a key liaison between the monitoring team, Clinical Project Management, cross-functional study teams and Sponsors, escalating risks and issues and supporting appropriate corrective actions.
Requirements
Bachelor’s degree in a relevant discipline
Nice to have: Clinical Operations Lead (COL) experience
Lead the planning and execution of European Union Clinical Trials Regulation Part II submissions throughout the study lifecycle.
Responsibilities
Lead the planning and execution of EU Clinical Trials Regulation Part II submissions
Partner with Clinical Trial Management and Regulatory Affairs to define country allocation, submission strategy, breakthroughs, and timelines
Coordinate Member State, institution, principal investigator, and site-level information and documentation required for clinical trial applications
Prepare and maintain accurate submission content in the Clinical Trials Information System and ensure alignment with national requirements
Collaborate with Clinical Transparency on document redactions and collect compliant documentation for In Vitro Diagnostic Regulation ethics submissions
Project Manager will provide staff oversight, project management, expertise, and administrative support for clinical trials in the Penn Infectious Diseases Clinical Research Unit.
Compensation
$63,085.00 - $78,231.00 Annual Rate
Responsibilities
Provide staff oversight and project management for clinical trials
Supervise research staff and manage study timelines
Develop and review regulatory submissions and study documents
Manage study budgets and ensure timely payments
Oversee data and sample management and compliance checks
Clinical research associate responsible for monitoring clinical trials, ensuring compliance, and supporting study execution across multiple sites.
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
Requirements
University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
Sr. Clinical Operations LeadAlimentiv · Toronto, Canada