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.
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.
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.
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.
Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits.
Oversee the execution of Site Activation, site activation strategy, adhering to project timelines.
Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent.
Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities. With hundreds of research locations, mobile clinics, and clinicians across the globe, they focus on ensuring every person has the opportunity to understand their health and access the care they need.
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.
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.
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.
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.
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.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Ensure the development and implementation of action plans.
Lead regional/therapeutic area project resourcing.
Develop, mentor, manage and coach GCM Managers.
Precision for Medicine is a global precision medicine clinical research services organization. They improve the clinical research and development process for new therapeutics by integrating clinical operations excellence, laboratory expertise, and advanced data sciences.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Build and operationalize a scalable clinical trial site management model leveraging IVX Health’s clinical and operational infrastructure.
Lead execution of clinical trials across multiple sites, ensuring protocol adherence, predictable study start‑up, and high‑quality administration and documentation.
Serve as the senior accountable leader for regulatory compliance, quality, SOP governance, training, documentation integrity, and CAPA.
IVX Health is a national leader in high‑quality infusion and injection therapy, operating 150+ ambulatory centers across the U.S. They are backed by Linden Capital Partners and continue to scale rapidly—expanding services, accelerating growth, and building the leading ambulatory infusion platform in the country.
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.
Ensures complete study scoping, including testing requirements, facilities and other nuances.
Provides technical details to study team for study designs and updates.
Conducts investigations and assists with implementation of corrective actions, as needed.
ACM Global Laboratories impacts patients and their families by being purposefully patient-driven. Their dedication is reflected in the high-quality work provided by their teams every day around the globe.
Guide field CRM implementation and maintenance with CRM implementation vendor.
Manage field alignment including field roster, zip to terr, HCO/HCP targeting and alignment.
Coordinate/manage sample operations and logistics with sampling vendor and field colleagues.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are headquartered in Radnor, Pennsylvania and are a fully remote company.
Performs on-site or remote monitoring visit activities.
Identifies investigators and verifies qualifications.
Trains investigational site staff as necessary.
Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility, creative contribution and realistic career development.
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.