Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management.
Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
Identify risks and propose solutions to facilitate clinical studies.
Nuvalent is working to create selective medicines designed to address the needs of patients with cancer. They are an exciting early-stage company with experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Oversee and manage regional operational activities of global pivotal trials.
Develop and oversee procedures for troubleshooting and problem solving.
Maintain effective communication with vendors and internal departments.
Prilenia is a private biopharmaceutical company focused on developing transformative medicines for neurodegenerative diseases. With a highly committed and talented global team, they are developing pridopidine, an investigational neuroprotective therapy for ALS and Huntington’s disease.
Support and observe clinical site monitoring services inhouse.
Provide monitoring and site management activities for full-service studies.
Conduct remote data review, support data query and closure activities.
Alimentiv is a global contract research organization (CRO) providing clinical trials and research services. While the employee count is not provided, they appear to foster a collaborative environment.
Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.
Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Responsible for operational oversight of the site, site health and monitoring activities.
Support sites in understanding study expectations, timelines, and required deliverables.
Build and maintain strong, trusted relationships with investigators and site staff.
CSL Behring is a global biotherapeutics leader committed to saving lives. They focus on serving patients’ needs by using the latest technologies to discover, develop, and deliver innovative therapies. CSL's parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
Provide medical expertise and leadership in clinical development strategies aligned with company objectives.
Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
Serve as medical monitor for clinical trials and ensure adherence to ICH GCP, patient safety, and data integrity.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of experience and global hubs in the U.S., France, and the U.K, they are committed to a culture of collaboration, excellence, and impact and empower every individual to be their true selves and grow alongside the company’s success.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Leads the Clinical Study Team for assigned projects from concept to protocol.
Manages external vendors and contract research organizations.
Manages operational activities at the study level and monitoring activities at clinical study sites to assure adherence to GCP, SOPs, and study protocols.
BridgeBio is committed to discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases with unmet needs. They build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Independently lead clinical projects in accordance with the study budget and scope of work.
Serve as the primary point-of-contact liaison with the client to provide excellent customer service.
Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
Precision for Medicine combines novel clinical trial designs, operational and medical authorities, advanced biomarker and data analytics solutions. They are a people focused CRO with a supportive and collaborative environment which promotes work life balance and encourages team development.
Lead and manage the day-to-day operational execution of assigned cell therapy trials.
Develop and manage study timelines, budgets, forecasts, and related operational metrics.
Partner with external vendors / CROs / service providers to ensure high quality and timely deliverables.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and are guided by their core values.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
Oversight of site level tasks associated with efficient site activation.
Support the CRA team in preparing for site initiation visits (SIVs).
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Fortrea helps to turn the impossible into I'm possible. They deliver exceptional service to their patients, fueled by a shared commitment to teamwork and excellence.
Develop, mentor, manage and coach PSS staff to progress their skills to maintain Precision quality standards.
Develop robust and flexible operational methodologies, standards and processes for the PSS role and ensure consistent, quality execution among the PSS personnel.
Manage and oversee the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team and sponsor input, and filing meeting agendas and minutes in the Trial Master File.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences to help life sciences improve the speed, cost and success rate of bringing therapies to patients. They have a strong focus on Oncology and Rare Disease.
Serves as the clinical trial lead responsible for the planning, conduct and oversight of clinical studies.
Develop study related clinical documents and generate potential site list from key stakeholders.
Manage processes for investigational product including drug accountability and reconciliation.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the speed, cost and success rate of bringing therapies to patients. They focus on Oncology and Rare Disease, providing deep scientific knowledge.
Lead the planning/execution of clinical studies, aligning with regulatory/business objectives.
Manage relationships with CROs, vendors, and external partners for timely/cost-effective study delivery.
Project manage clinical trials, overseeing timelines, budgets, and deliverables.
Jobgether is a platform that helps connect job seekers with companies. They use AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements.