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.
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.
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.
Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
Train investigational site staff and support regulatory submissions as applicable.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.
Facilitate negotiations of site agreements and budgets to ensure alignment with the site activation plan.
Customize and prepare country- and site-specific agreements and organize their translations.
Track the status of site agreement and budget negotiation, preparing executable versions and coordinating the signature process.
We are a dynamic, global company founded in 1995, bringing together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives and bringing new medicines to those who need them.
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.
Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
Identify study risks and propose mitigation strategies while maintaining high quality and detail.
Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.
Coordinate participant recruitment start-up activities for assigned clinical trials.
Manage sponsor-funded marketing budgets and track expenditures to optimize ROI.
Liaise with vendors, sponsors, and regulatory bodies to ensure compliant campaign launches.
Headlands Research is a leading network of advanced clinical trial sites that leverages technology and support services to enhance clinical trial delivery and community outreach. Founded in 2018, the company operates 20+ sites across the US and Canada and is rapidly growing.
Review, draft, negotiate, and track legal agreements, including confidentiality and clinical study agreements.
Manage site contract strategy and execution across APAC, including budget negotiations.
Collaborate with clinical operations teams to align deliverables with study timelines.
Precision for Medicine is a CRO that integrates new technologies, operational scale, and advanced data sciences to improve the speed and success of life-changing therapies. Its culture emphasizes detail-oriented, multi-faceted problem-solving and collaboration within project teams.
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.
Review, draft, and negotiate clinical study agreements, confidentiality agreements, and other legal contracts.
Collaborate with Clinical Operations study teams to ensure contract deliverables align with study timelines.
Track, report, and manage site contract metrics while maintaining contract files and databases.
Precision for Medicine is a clinical research organization focused on advancing precision medicine through clinical trials and related services. It is part of the broader Precision Medicine Group, which emphasizes innovation, collaboration, and high-quality delivery.
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 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.
Manage all clinical aspects of assigned studies across multiple countries, ensuring timeline adherence and quality.
Lead CRAs and support site selection, start-up, enrolment, monitoring, data cleaning, and close-out.
Identify risks to timelines and collaborate with teams to deliver high client satisfaction.
Precision for Medicine is a precision medicine CRO combining novel trial designs, operational experts, and biomarker analytics with a focus on oncology and rare diseases. It encourages high-energy professionals who thrive in dynamic environments.
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.
Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Lead clinical research project planning, execution, and delivery, ensuring regulatory compliance and quality.
Coordinate cross-functional teams and manage timelines, budgets, and study documentation.
Serve as the primary sponsor and client contact, providing regular project updates and resolving issues.
Alimentiv is a global CRO advancing therapies for gastrointestinal diseases, with deep expertise in IBD drug development. With about 700 employees across multiple countries, it is a private, profit-with-purpose company focused on scientific research and its people.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.