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.
Lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight.
Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.
CoMind is developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring.
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 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.
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.
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.
Lead Braveheart’s global PV strategy and partner closely with Clinical, Regulatory, and other development functions.
Lead all PV contributions to Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions worldwide, with responsibility for developing high-quality safety sections.
Shape the future PV function— its people, structure, and operating model— as Braveheart transitions from clinical development to post-market commercialization.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
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.
Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
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 and are exemplified by each and every one of their team members.
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.
Accountable for the management, performance, quality improvement and scalability of our HCP contractor base. Work cross-functionally with Product, Medical Directors, Data, Regulatory, Patient Experience, and Pharmacy teams. Combine people leadership, operational rigour, analytical ownership, and applied AI/automation in a regulated healthcare environment.
Founded in 2019, Felix is a patient-driven digital healthcare company that puts you in control of your health and wellbeing.
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.
The Senior Manager of Clinical Data Management (CDM) is responsible for overseeing the execution, quality, and operational excellence of data management activities across Phase IV, post-marketing, and real-world evidence (RWE) studies. Plays a key role in shaping data delivery strategy, driving cross-functional collaboration, and ensuring consistent, high-quality outcomes across a growing portfolio. Requires strong technical expertise, exceptional leadership capability, and the ability to operate strategically while maintaining hands-on oversight of complex data workflows.
Paradigm is rebuilding the clinical research ecosystem by enabling equitable access to trials for all patients.
The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.
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.