Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.
Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
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.
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.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Collaborate with project teams and clinical sites to support study startup, training, and device deployment.
Ensure compliance with GCP, ICH guidelines, and regulatory standards while monitoring project progress.
Address operational issues and provide feedback to improve devices and workflows.
Beacon Biosignals is transforming precision medicine for the brain by offering at-home EEG platforms for clinical development and diagnostics. The company fosters a remote-first culture with office hubs in Boston, New York, and Paris, emphasizing asynchronous work and collaboration.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
Conduct on-site or remote monitoring visits including Pre-Study, Initiation, Interim, and Close-Out activities to ensure site adequacy and compliance.
Verify investigator qualifications, resources, and facilities, and train investigational site staff as necessary.
Support regulatory submissions and mentor junior staff through co-monitoring visits and training.
Ergomed Group is a clinical research organization (CRO) that helps biopharmaceutical companies develop, deliver, and safeguard therapies in oncology, rare disease, and other complex areas. The company fosters a culture of kindness, curiosity, and a shared sense of purpose, with a diverse team of experts in clinical research, pharmacovigilance, and quality consulting.
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.
Oversee clinical study operations from startup through close-out, ensuring quality and compliance.
Act as primary operational partner to sponsors, project teams, and clinical sites.
Foster a culture of quality by coaching peers on GCP compliance and documentation discipline.
Beacon Biosignals is transforming precision medicine for the brain, offering EEG and cardiopulmonary platforms for clinical development and diagnostics. The company has office hubs in Boston, New York, and Paris, and fosters a first-class remote work culture with a focus on diversity and impact.
Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
Maintain expertise in GCP, EU regulations, and support business development activities.
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.
Lead all clinical study operations, providing strategic planning and direction from inception through completion.
Serve as the primary contact with sponsors and oversee study budgets, timelines, and vendor management.
Mentor and motivate study team members while ensuring compliance with GCP, protocols, and regulatory requirements.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Our team of skilled professionals is committed to advancing clinical research with care, integrity, and excellence, fostering a collaborative and supportive culture.
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.
Provide high-level logistical support for clinical study operations, including study start-up, site management, and monitoring.
Develop and manage study-related documents such as protocols, informed consent forms, and monitoring plans.
Oversee clinical trial supplies, vendor management, and ensure compliance with regulatory requirements.
Natera is a global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health. Our team consists of highly dedicated professionals from world-class institutions who care deeply for our work and each other, working hard and growing quickly.
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.
Conduct risk-based quality control assessments and on-site visits to ensure investigational sites adhere to study protocols, GCP, and company procedures.
Develop and maintain study-specific QC plans, tools, and reports, and drive trend analysis and issue resolution with clinical operations teams.
Support inspection readiness and contribute to training and process improvements based on QC findings and regulatory insights.
Zai Lab is a commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and worldwide. Founded in 2014, the company has a global team of about 2,000 employees, with a strong commitment to gender diversity and a culture that promotes women in biotech.