Source Job

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 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.

• 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.

• 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.