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.
Coordinate planning, implementation, and delivery of device logistics projects for eCOA clinical trials.
Oversee budgets, deployment plans, and risk mitigation while collaborating with clinical teams and stakeholders.
Ensure inventory management, mobile device management, and global shipping are completed on schedule and within scope.
The hiring company is a life sciences organization specializing in device logistics and electronic clinical outcome assessments for clinical trials. They foster a collaborative, cross-functional remote culture aligned with US East Coast time zones.
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.
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.
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.
Lead medium- to high-complexity clinical trials with full accountability for timelines, budgets, resources, and quality.
Oversee financial performance, risk mitigation, and quality standards while ensuring regulatory compliance.
Mentor Project Leaders and represent project leadership in client meetings, bid activities, and conferences.
A clinical research organization managing complex clinical trials and therapies. It fosters a fast-paced, collaborative environment focused on innovation, accountability, and professional development.
Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.
Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.
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.
Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.
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.
Lead and oversee global Phase 0-4 clinical trials with cross-functional teams from inception to closure.
Manage external vendors, recruitment strategies, and study systems to ensure quality, efficiency, and inspection readiness.
Collaborate with study project managers to drive timelines, budgets, and compliance with ICH/GCP and AbbVie policies.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and Allergan Aesthetics. They are a global, science-driven pharmaceutical company committed to integrity, innovation, and serving the community.
Leads end-to-end project planning and delivery for small to medium customer implementation projects. - Serves as primary project contact, building trust through transparent communication and proactive issue resolution. - Creates and maintains project documentation including plans, status reports, and risk assessments.
Intelerad provides medical imaging solutions to streamline healthcare information flow. With nearly 800 employees across four countries, we empower over 2,000 healthcare organizations to improve patient outcomes.
Lead data management activities for assigned clinical trials, ensuring quality and integrity of data.
Serve as subject matter expert on multidisciplinary teams and oversee CRO/vendor compliance.
Support temporary remote role requiring 20 hours/week and US work eligibility.
Penumbra is a global healthcare company focused on innovative therapies for challenging medical conditions. It designs, develops, manufactures, and markets novel products, and fosters a collaborative teamwork environment where learning is constant and performance is rewarded.
Lead or co-lead medical writing and document quality projects, managing timelines.
Collaborate with cross-functional study teams to develop content strategies.
Review and verify documents against source materials for accuracy and compliance.
This partner company works in pharmaceutical and biotech development, creating scientifically rigorous medical content for evidence-based healthcare decisions. It emphasizes collaboration, professional development, and an inclusive culture.
Oversee commercial real estate, construction, and facilities-related projects from planning to delivery.
Manage budgets, schedules, design reviews, and coordination with clients, consultants, and contractors.
Monitor financial performance, identify risks, and ensure regulatory compliance for successful outcomes.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses technology to ensure applications are reviewed quickly and objectively.
Partner with Clinical Scientists and Clinician Services leaders to design and deliver study-specific training programs.
Develop calibration strategies, monitor clinician performance, and implement quality improvements.
Lead group training, coaching, and documentation while ensuring GCP and regulatory compliance.
Clario, part of Thermo Fisher Scientific, provides endpoint data solutions for clinical trials. Its global team has supported over 30,000 clinical trials and 70% of FDA drug approvals since 2015.
Serve as primary operational contact and mentor junior staff for global Phase 1-3 trials.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. It is a small, dynamic company offering an exciting opportunity to contribute to its immunology pipeline.
Lead the development and execution of clinical development plans for exploratory and biopharmaceutics programs.
Oversee global clinical trial operations, including timelines, budgets, vendors, and cross-functional collaboration.
Drive risk management and strategic decision-making across the molecule lifecycle.
The hiring company is a pharmaceutical organization focused on clinical development and biopharmaceutics. It values learning agility, innovation, inclusion, and collaboration in a virtual and matrixed environment.
Provide administrative and personal support including calendar management, scheduling, and meeting logistics.
Coordinate project communications, track progress, and prepare status reports for teams and leadership.
Manage virtual and in-person meetings, materials, and stakeholder follow-up.
The American Heart Association is a nonprofit organization dedicated to fighting cardiovascular disease and stroke. With over 100 years of leadership, it employs thousands and fosters a culture of work-life harmonization through resources like Heart U and employee support programs.