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.
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.
Lead the development, manufacturing, assembly, and commercialization of high‑concentration biologic delivery systems.
Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks.
Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. It appears to be a growing company with a focus on innovation.
Serve as primary operational lead and chair for both PRC (promotional) and MRC (medical) workflows.
Oversee development-to-distribution workflows for all approved print and digital materials.
Build and maintain scalable SOPs, workflows, templates and governance frameworks.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company, preparing for its first commercial launch, with an entrepreneurial culture and a focus on establishing foundational capabilities for commercialization.
Lead the end-to-end clinical data management strategy for Phase 3 and late-stage clinical trials.
Provide hands-on oversight of CROs and external data management vendors, ensuring delivery against timelines, quality, and budget.
Partner closely with Biostatistics to support interim analyses, database locks, and final clinical study reports.
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 high-profile and rapidly evolving therapeutic area.
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.
Own and scale Snorkel’s BPO and supply partner ecosystem to support global, 24/7 delivery.
Define and execute the strategy for partner expansion, ensuring balanced geographic coverage and reduced concentration risk.
Manage partner relationships end to end, including quality standards, performance tracking, communication, and regular operating cadences.
Snorkel AI helps enterprises transform expert knowledge into specialized AI at scale. They started as a research project in the Stanford AI Lab and work with some of the world’s largest organizations. As a rapidly scaling company with robust funding, Snorkel AI offers a unique combination of stability and the excitement of high growth.
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.
Assist in design, author and/or review clinical study synopses, protocols, study reports and other study-related documents.
Act as a medical monitor for assigned study and discuss study design with investigators and key opinion leaders.
Track emerging efficacy and safety profile of drugs in clinical trials; inform Clinical Development team of changes in the efficacy/safety profiles.
Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. The company aims to improve cancer treatment by targeting cellular drivers of tumor growth and is publicly traded.
Play a key role in the safe, efficient, and effective Investigational Product preparation and administration in clinical trials.
Review and provide input on Investigational Product Preparation Instructions, Site Investigational Product Procedures Manual, and monitoring guidelines.
Establish and maintain good and productive working relationships with internal and external stakeholders.
ICON plc is a world-leading healthcare intelligence and clinical research organization. They pride themselves on fostering an inclusive environment and welcome people to join their mission to shape the future of clinical development.
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 and drive the global API strategy across Praxis’ portfolio.
Lead the design, development, and industrialization of robust, phase-appropriate drug substance processes.
Build and lead a high-performing, multidisciplinary ecosystem of internal talent and external partners.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Serve as the primary Project Manager for Global (Non US) Clinical Training and Programming
Develop and implement a Global Clinical Training and Programming strategy that is sustainable for continued growth
Coordinate logistics such as creating virtual events platforms, finding clinical providers, ensuring materials are prepared, tracking reporting and evaluation metrics
Spring Health is on a mission to revolutionize mental healthcare by removing every barrier that prevents people from getting the help they need, when they need it. The company partners with over 450 companies, from startups to multinational Fortune 500 corporations, providing care for 10 million people.
Support the design, specifications, and development of eCRFs
Develop Data Management Plan documents
Manage effective communication of data issues and discrepancies to study sites via the query management process
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 redefining what’s possible.
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.
The Clinical Team Manager will be responsible for site level operational study management.
Proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary.
Verifying and ensuring that project team members are trained to perform their assignments.
Ergomed is a full-service mid-sized CRO specializing in Oncology and Rare Disease. They have operations in Europe, North America, and Asia and have nourished a true international culture. They value employee experience, well-being and mental health.
Stand up and run the daily clinical operations for PIN/CHI delivery.
Define the care team structure, supervision ratios, and operating cadence.
Ensure billing-ready documentation is completed correctly every time. Partner with Compliance + RCM support to prevent leakage/denials caused by ops errors.
Carewell is focused on providing the most trusted and reputable retail source for caregiving products. They have been recognized as one of the fastest-growing companies in the US.
AppDirect offers a subscription commerce platform to sell any product, through any channel, on any device - as a service, powering millions of subscriptions worldwide for organizations. Their values-driven culture enables you to Be Seen, Be Yourself, and Do Your Best Work.