Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Manage regulatory submissions and site activation readiness across the UK.
Negotiate budgets and contracts with sites and vendors.
Coordinate with ethics committees and competent authorities for approvals.
Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.
Lead planning, execution, and oversight of clinical studies across Latin America.
Act as primary client contact and ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
Mentor CRAs and partners while shaping country-level recruitment and monitoring strategies.
Precision Medicine Group provides clinical development, regulatory, and commercial solutions for life sciences companies. It fosters a collaborative, high-integrity culture with opportunities for growth and leadership in a global remote environment.
Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Monitor clinical investigative sites to ensure protocol execution and regulatory compliance.
Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1-4 studies.
Train site personnel, manage investigator payments, and identify new investigators and sites.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, and neuroscience. It is a global biopharmaceutical company committed to integrity, innovation, and transforming lives.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Provide medical oversight for clinical trials, safeguarding participant safety and ensuring protocol compliance.
Review adverse events and safety data, contributing to regulatory reporting and clinical documentation.
Collaborate with investigators and clinical teams to support study design, execution, and risk management.
This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.
Collaborate with project teams to support study startup and serve as primary point of contact for clinical sites.
Provide training on Beacon's devices and protocols, monitor progress, and maintain GCP/ICH compliance.
Address operational issues via Zendesk and Asana and deliver actionable site feedback for workflow improvements.
Beacon Biosignals is transforming precision medicine for the brain with at-home EEG and cardiopulmonary monitoring platforms for clinical development and diagnostics. They foster a remote-first culture with hubs in Boston, New York, and Paris, emphasizing curiosity, simplicity, and empathy.
Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.
Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and MedTech innovators turn breakthroughs into new treatments. The company fosters a collaborative culture focused on agility, continuous learning, and making an impact.
Oversee EMEA clinical trial operations, partnering with CROs and sites to ensure compliance and timely execution.
Lead regional regulatory submission strategies and proactively resolve operational challenges to maintain study timelines.
Mentor junior team members, review data and TMF documentation, and provide regular study updates to stakeholders.
Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformative treatments for metabolic diseases. The company fosters a collaborative culture of problem solvers dedicated to bringing bold scientific approaches to patients.
Monitor global regulatory developments across 150+ countries and assess impact on pharmaceutical and MedTech industries.
Ensure accurate structured data entry in the regulatory intelligence platform, combining GxP knowledge with data operations.
Communicate regulatory updates and trends clearly to support smarter, faster decisions across the enterprise.
Redica Systems is the Intelligence Cloud for life sciences, transforming regulatory complexity into connected, proactive intelligence. Their platform helps leading pharmaceutical and MedTech companies stay inspection-ready, manage supplier risk, and comply with global regulations in a fast-paced, high-growth environment.
Manage all clinical operational aspects of global trials including start-up, conduct, and close-out.
Oversee CRO and site adherence to GCP and SOPs, proactively identifying and resolving study risks.
Lead study team meetings, build investigator relationships, and support protocol development.
Vera Therapeutics is a commercial-stage biotech focused on transforming autoimmune disease treatment, starting with the kidney. Founded in 2016 in Brisbane, CA, the company values empathy, ownership, clarity, and urgency in a collaborative, fast-paced team.
Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
Oversee monitoring, compliance, and data analysis while mentoring junior staff.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Lead safety evaluation and benefit-risk assessments for assigned products.
Support pharmacovigilance and risk management activities across clinical development and marketed products.
Contribute to regulatory submissions and health authority interactions.
Alphanumeric is a staffing and recruiting company that connects specialized professionals with global organizations. It is currently supporting one of the world's largest pharmaceutical companies in filling a contract medical director position.