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.
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.
Serve as primary point-of-contact and primary escalation point to the client.
Coordinate and oversees all functional services including external vendors to the established timeline and budget.
Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing therapies to patients. They focus on Oncology and Rare Disease and strive to ensure employees feel appreciated and valued for their contributions every day.
Oversee clinical budgets and develop monitoring plans for effective study oversight.
Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
Drive enrollment and lead study start-up activities, adhering to timelines.
Jobgether employs AI to match candidates to job openings, ensuring fair and objective reviews. They connect top candidates with hiring companies, who then manage the final decisions and interview process.
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.
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.
Oversees all aspects of study site management to ensure patient safety is protected and quality of data is generated.
Independently conducts all forms of site visits in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for complex disease states. They strive to ensure employees feel appreciated through a multitude of benefits and value their ideas and contributions.
Manages central laboratory and specialty vendors across clinical trials.
Provides support for sample related matters to clinical study teams.
Assists with vendor selection and oversight.
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.
Responsible for leading and managing early and late phase imaging projects.
Manage the study to contract specifications and timelines.
Prepare project plans and manage various study projects in varied phases of study lifecycle.
Perceptive's mission is to shape the future of clinical research. Our global team delivers unmatched scientific and technological expertise, global operational experience, and end-to-end solutions to help the global research community realize tomorrow’s new therapies.
Directs the operational oversight and execution of clinical site start-up.
Manages CRO relationship and oversight to ensure appropriate scope of work.
Develops collaborative relationships with investigative sites.
Bristol Myers Squibb is focused on developing innovative drugs against targets of solid tumors. They are a dynamic biotechnology company headquartered in San Diego, CA, and aim to be the global leader in radiopharmaceuticals.
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.
Manage and drive continuous process improvement initiatives.
Oversee all daily, end to end, clinical trial/patient matching operations.
Serve as a liaison between trial sites, sponsors, and drive project delivery.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for their work and each other.
Oversight for traveling clinical staff supporting decentralized operations at events and sites.
Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).
Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.
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.
Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
Establish and lead the clinical operations strategy, setting departmental goals.
Promote strong cross‑functional collaboration with internal stakeholders.
McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.
Coordinate and assist with trial start-up activities.
Facilitate resolution of laboratory queries.
Track and report on study progress.
Freenome is dedicated to changing the landscape of cancer through early detection. They value diversity and do not discriminate based on various statuses protected by law.
Provide leadership for the Data Management group and ensure quality data.
Oversee DM vendors' deliverables and maintain strong collaboration.
Create procedures for data collection, review, and cleaning processes.
Definium Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for brain health disorders. They aim to be a global leader in delivering innovative treatments to improve patient outcomes and are expanding their global presence.