Source Job

• Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
• Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
• Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate all necessary activities required to set up and monitor a study.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.

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 boast extremely high CRA retention rates compared to industry averages.

As Clinical Trial Manager, you will lead CRAs and oversee clinical aspects of studies across multiple countries. You will ensure timeline adherence and scope, whilst ensuring quality delivery. Management and operational delivery of the clinical elements within a trial including site selection, start-up, and data cleaning activities. Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.

Precision for Medicine is a precision medicine CRO which combines novel clinical trial designs, experts and biomarker solutions.

• Lead and manage complex clinical oncology projects.
• Coordinate cross-functional activities and external vendors.
• Guide project planning, risk management, and compliance efforts.

This position is posted by Jobgether on behalf of a partner company.

Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.

This position is posted by Jobgether on behalf of a partner company.

Accountable for the operational management and execution of global clinical trial programs (Phases I-III). Ensure adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. Partner with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications.

• Assist with the development of the protocol and informed consent form and/or program design.
• Manage vendor budgets, payments, and timelines.
• Effectively track and report on internal project metrics and study progress.

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate activities to set up and monitor a study.
• Train and mentor junior staff members.

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the success rate of therapies for patients. They cultivate their culture and have high CRA retention rates compared to industry averages.

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.

ICON plc is a world-leading healthcare intelligence and clinical research organization. ICON fosters an inclusive environment driving innovation and excellence.

• Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.

Precision for Medicine combines novel clinical trial designs, operational and medical authorities, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology. They are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development.

The Medical Director oversees clinical trials, data collection, and protocol implementation. Manages program development, working cross-functionally with various disciplines. Supports data analysis and contributes to the preparation of abstracts, presentations, and manuscripts.

Iovance is committed to cultivating and offering a diverse and inclusive work environment as an equal-opportunity employer.

• Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities.
• Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs.
• Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease.

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

• Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
• Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
• Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.

• Lead complex clinical trials from initiation through completion.
• Oversee cross-functional teams and manage project scope.
• Contribute to high-impact clinical research projects.

This position is posted by Jobgether on behalf of a partner company.

• Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
• Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.

Fred Hutchinson Cancer Center is a non-profit organization focused on adult cancer treatment and research. They are based in Seattle and have a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines.

• Assist with daily site activities, acting as the primary point of contact for the site.
• Assist with training and mentoring research staff, upholding professional development goals.
• Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.

Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.

• Represent Iovance Medical Affairs as a TIL cell therapy expert in both internal and external venues.
• Provide high quality clinical input and review of disease strategy plans, slides, manuscripts and educational materials.
• Partner with Scientific Communications to develop timely publication strategies and plan, gap analysis, and key messages.

Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.