Source Job

• Provides operational leadership for global clinical trials, overseeing the clinical operations team and vendor performance.
• Ensures effective study delivery through cross-functional collaboration, proactive risk management, and strong execution oversight.
• Manages CROs, vendors, and strategic partners, driving financial accountability and maintaining inspection readiness.

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. With multiple global Phase 3 clinical studies, the company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

• 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.

• Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
• Review electronic medical records and source documentation for accuracy and data integrity.
• Support site staff and contribute to development of trial materials, SOPs, and training guides.

Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.

• 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.

• Lead interdisciplinary oncology clinical research projects from study launch through closeout, ensuring quality, timelines, budgets, and compliance.
• Serve as the primary liaison between the organization and the sponsor, overseeing project deliverables, risk management, and financial performance.
• Maintain accountability for study documentation, inspection readiness, and accurate information across relevant databases and systems.

Jobgether uses AI to match job seekers with roles. They are a platform that partners with hiring companies to manage applications and next steps.

• Manage Investigator sites and conduct on-site and centralized monitoring visits to ensure subject safety and data integrity.
• Collaborate with cross-functional teams and external partners to maintain quality study oversight from start-up through close-out.
• Support development of study documents, maintain TMF, and ensure inspection readiness while embodying core company values.

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The company combines cutting-edge technologies like optogenetics and spatial transcriptomics to identify novel drug targets, with a culture of integrity, collaboration, bravery, and dedication.

• Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
• Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
• Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.

• Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
• Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
• Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.

CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.

• Lead and oversee global clinical trials from inception to closure, managing cross-functional teams and vendors.
• Ensure compliance with ICH/GCP and regulatory standards while driving recruitment and risk management strategies.
• Manage study materials, systems (EDC, IRT, CTMS), and provide training to stakeholders.

AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines in immunology, oncology, neuroscience, and aesthetics. With a global presence, they emphasize integrity, innovation, and community service.

• 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.

• Take your career to the next level and lead challenging global clinical research projects.
• Manage the full scope of responsibilities and get hands-on involvement in every aspect of the study.
• Work remotely or hybrid while managing multi-functional project teams and client relationships.

PSI is a leading Contract Research Organization with 30 years of experience, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications, and invest in their people's professional development.

• Oversee strategic planning and execution of global clinical studies.
• Manage internal and external resources, including CROs, to ensure quality and compliance.
• Lead cross-functional teams and contribute to trial design and budgeting.

Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.

• Lead clinical trial execution and operational delivery across internal and external stakeholders from start-up through execution.
• Provide oversight of CROs, vendors, and clinical trial partners to ensure quality, compliance, timelines, and budget objectives are achieved.
• Serve as the Clinical Operations leader for the team of CTMs, CRAs, and CTAs for each assigned project.

Immatics is a global leader in precision targeting of PRAME for cancer immunotherapy, with a robust clinical pipeline spanning TCR T-cell therapies and TCR bispecifics. The company fosters a collaborative and innovative culture focused on making a meaningful impact on patients.

• Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
• Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
• Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.

• Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
• Manages external vendors, recruitment strategies, and cross-functional team coordination.
• Maintains inspection readiness and contributes to risk management and process improvement.

AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.

• 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.

• Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
• Gather site feedback and translate it into actionable improvements for study teams.
• Contribute to protocol development, site selection, and business development activities.

This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.

• 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.

• Manage global, multi-center clinical research projects in a variety of therapeutic areas.
• Deliver projects on time, within budget, and in accordance with high quality standards.
• Lead and mentor project teams, and serve as the primary point of contact to clients on all project matters.

PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. They focus on delivering quality and on-time services across a variety of therapeutic indications.