Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
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.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Management and operational delivery of the clinical elements within a trial.
Successful execution of assigned trials and ensuring completion of trial deliverables.
Identify challenges to study timelines/deliverables and offer creative action plans.
Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
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.
Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
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.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Perform discovery visits to access sites for research partnerships.
Provide protocol and product/procedural training to clinical sites.
Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.
Considered as the primary point of contact for the investigative site and strengthens AbbVie’s positioning.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision.
Develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment.
AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues. They strive to have a remarkable impact on people's lives across several key therapeutic areas.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
Maintain knowledge of regulations applicable to submissions for medical devices.
Communicate technical and scientific information to project teams and regulatory authorities.
Collaborate with cross functional teams to develop regulatory strategy.
Cook Research Inc. manufactures medical devices and is part of the Cook Group companies. They are committed to equal employment opportunities and value diversity within their workforce.
Collaborate with dedicated research sites contributing to rare neurological disease research.
Make a significant impact in the scientific community alongside a dedicated team of CRAs.
Encompass important site monitoring and management activities including SIVs Interim and Remote Monitoring Visits as well as Final Onsite and Closeout Visits.
St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital providing health, social, and support services. They are dedicated to caring for the poor and underserved, and are known for quality quaternary care, medical education, and research.
Prepare budgets, proposal text and re-bids to support RFP responses.
Coordinate RFP development meetings with sales, operational review and finance teams.
Ensure accuracy and quality control of budget and proposal text edits.
Precision for Medicine is a precision medicine CRO with a uniquely integrated offering. They combine novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
Accountable for study level tracking as assigned by the Clinical Project Manager.
Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel.
Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients.
Independently oversees study site management, ensuring patient safety and data quality.
Manages site start-up procedures, including feasibility, regulatory submissions, and document review.
Conducts site visits, prepares reports, and communicates with site personnel and project management.
Precision for Medicine integrates new technologies, expertise, and operational scale to improve the speed, cost, and success rate of life-changing therapies. They integrate clinical trial execution with scientific knowledge, lab expertise, and data sciences with a focus on Oncology and Rare Disease.
Lead and oversee end-to-end clinical trial operations from study start-up through close-out.
Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.
Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single-asset companies to improve productivity.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.