Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Drafting, negotiating, and executing clinical site and ancillary agreements in compliance with country regulations and project timelines.
Tracking site contracting progress, providing clear rationales for delays, and escalating issues with contingency plans.
Acting as a country-level subject matter expert on site contracts for internal and sponsor stakeholders.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. They have built a collaborative international team across North America, South America, Europe, Asia, and Australia, valuing teamwork, flexibility, and work-life balance.
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Review, draft, and negotiate a variety of legal agreements including clinical study agreements and confidentiality agreements.
Work closely with Clinical Operations study teams to ensure contract deliverables align with study timelines.
Establish, track, and report site contract metrics and support contract file maintenance.
Precision for Medicine provides clinical research services to the pharmaceutical and biotechnology industries. The company is part of Precision Medicine Group and fosters a collaborative culture focused on precision medicine.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Review, draft, and negotiate legal agreements including CDAs, CTAs, amendments, and site budgets.
Lead interactions with internal study teams and external sites and sponsors to resolve contractual issues.
Coordinate contract execution and maintain accurate contract files and databases.
Precision Medicine Group is a specialized contract research and clinical services organization. It is an equal opportunity employer with a global team, focused on supporting life sciences and biotech clients.
Collect, review, and prepare site and regulatory documentation for UK clinical trial submissions.
Support regulatory submission preparation and ICF adaptations in compliance with ICH-GCP and local regulations.
Liaise with investigative sites to obtain, track, and resolve outstanding documentation and maintain study tracking systems.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We seek out diverse talent with a relentless commitment to innovation and impact.
Coordinate participant recruitment start-up activities for assigned clinical trials, managing project timelines and deliverables.
Manage sponsor-funded recruitment budgets, track expenditures, and coordinate with finance and vendors.
Serve as primary operational contact for sponsors, regulatory submissions, and vendor management to ensure compliant and timely recruitment.
We are dedicated to enhancing clinical trial delivery within our communities as a leading network of advanced clinical trial sites. We leverage cutting-edge technology and support services, and since founding in 2018, we have grown to 20+ sites across the US and Canada.
Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.
Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.
Support clinical trial activities across patient engagement, study coordination, recruitment, regulatory support, data management, and operations.
Coordinate participant visits, recruitment, and regulatory documentation while maintaining accurate information in clinical research systems.
Foster communication between sponsors, CROs, investigators, and sites to ensure study compliance and milestone achievement.
This partner company supports fast-growing remote clinical research environments, helping keep clinical trials organized, compliant, and moving forward. They collaborate with research sites, sponsors, CROs, and healthcare organizations globally, offering multidisciplinary roles in a remote setting.
Manage and track customer contracts and renewals, proactively identifying expansion opportunities.
Prepare and issue proposals and quotations in partnership with Customer Success, Finance, and the commercial team.
Lead all client contract communications, serving as a trusted advisor and ensuring accurate execution.
Mural Health is a fast-growing clinical technology start-up that makes clinical trials easier for participants. Their mission is to eliminate any barriers participants or caregivers experience while being part of a clinical trial.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.
Identify and source clinical vendors through market research and protocol analysis.
Lead contract negotiations and vendor selection to ensure cost-effective procurement.
Manage vendor performance and compliance, serving as the escalation point for issues.
Care Access is making the future of health better for all by bringing world-class research and health services directly to communities. With hundreds of research locations, mobile clinics, and clinicians across the globe, we put people at the heart of medical progress.
Oversee CRO and vendor activities while directly contributing to study start-up and conduct including site initiation and monitoring visits.
Verify accuracy and completeness of clinical data, source documentation, and regulatory files ensuring compliance with GCP, GDPR, and regulations.
Identify and resolve discrepancies in study documentation and maintain Trial Master File for audit readiness.
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care through biomimetic TAVR valves. The company has a growing and inclusive team with offices in the US, Switzerland, and Australia.
Manage day-to-day clinical trial operations, including CRO/vendor oversight and site management.
Lead cross-functional study teams, develop study documents, and implement risk mitigation strategies.
Ensure high-quality deliverables within timelines and budget, from start-up through close-out.
Ultragenyx is a biopharmaceutical company dedicated to developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture focused on learning and growth, with a global team committed to innovation.
Support operational execution of clinical studies from initial synopsis through final deliverables.
Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
Oversee cross-functional study teams and ensure compliance with regulations and data integrity.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.