Source Job

• 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.

• 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.

• 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.

• Perform on-site monitoring visits and ensure site compliance with regulatory requirements and Good Clinical Practice.
• Ensure site maintains an accurate inventory and accountability of investigational drug and clinical supplies.
• Facilitate resolution of problems, queries and action items.

Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases.

• Ensure compliance with standard protocol and regulatory obligations in clinical site monitoring.
• Complete on-site and remote monitoring activities, including source document verification.
• Write and submit reports of investigational site findings and update tracking systems.

At Freenome, they are dedicated to changing the entire landscape of cancer.

• 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.

• 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.

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.

• 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 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.

• 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.

• 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.

• 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.

• 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.

• 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.