This position supports the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data.
Responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts.
Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner.
Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures.
Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. They aim to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Their values inspire employees every day.
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.
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.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
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.
Leads the cross-functional Trial Team (CTT); tracking of project deliverables & timelines.
Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs)
Accountable for the delivery of the trial within agreed/projected life of trial budget.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
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.
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.
Own the post-onboarding education roadmap and programming calendar.
Translate data insights into targeted education plans and measurable adoption strategies.
Design cohort-based learning models (role-based, topic-based, and performance-based).
Midi is a virtual care company focused on women’s health and whole-person care, delivering high-quality care through a tech-forward platform. As they grow, Midi aims to scale post-onboarding education to maintain clinical excellence and practice consistency.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
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, they represent an outstanding opportunity for ambitious, mission-driven professionals.
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.
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.
Directly lead and manage a Patient Support team to ensure medication adherence or provide timely prior authorization and financial assistance.
Proactively manage support in assigned hospitals/clinics to ensure patients receive medications on time and that all service level goals are met.
Manage all aspects of ADP, Paid Time Off (PTO), and Time Reports for team members while completing audits of the team in supported systems.
Shields Health Solutions provides specialty pharmacy management services, helping patients get medications on time. They are a fast-growing company that values motivated self-starters focused on high quality.
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.
Ownership of scientific and operational statistical work for clinical trials.
Develop study Statistical Analysis Plans and study documents.
Provide statistical expertise in support of interactions with regulatory agencies.
Tarsus is dedicated to attracting and retaining top talent. The company offers comprehensive benefits, bonus, and stock equity to promote work-life balance.
Bring medical and scientific expertise to the design, execution, and interpretation of clinical studies ensuring patient safety and scientific integrity
Author and oversee key clinical documents including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions
Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding our presence and global footprint, searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team.
Manage complex medical issues, coordinating care, facilitating best diagnostic and therapeutic treatment options available world-wide, and navigating the healthcare system.
Offer high level clinical management and education to clients and families in a caring, compassionate manner.
Work closely with clinical and research team, identifying latest therapies and delivering comprehensive information on medical conditions, medications, treatments, and clinical trials.
Private Health Management (PHM) supports people with serious and complex medical conditions, helping them obtain the best possible medical care. They guide individuals and families to top specialists, advanced diagnostics, and personalized care offering independent, science-backed insights to help clients make informed decisions and access the best care.
Oversight of all project related quality activities
Drive project related quality improvement and providing quality advice
Client management including direct oversight for client quality related activities for project
PrimeVigilance, part of Ergomed Group, is a mid-sized pharmacovigilance service provider established in 2008. They offer services in medical information, pharmacovigilance, regulatory affairs, and quality assurance, with staff across Europe, North America, and Asia. They maintain long lasting relationships and becoming one of the global leaders in its fields.
Provide direct supervision, coaching, and performance oversight to clinical managers.
Serve as a primary operational liaison between clinical teams and health plan care management teams.
Oversee onboarding and training for care teams and clinical managers.
Tuesday Health is a value-based palliative care provider group dedicated to transforming serious illness and end-of-life care. They deliver goal-centered care focused on alleviating physical symptoms and emotional stress for individuals and their caregivers. They cultivate a dynamic and inclusive team environment.