Independently manage all operational aspects of Phase I clinical trials from startup through closeout, ensuring adherence to protocols and regulations.
Oversee CROs and vendors to ensure alignment with study goals, budget, and timelines.
Lead the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Lead global Phase I virology clinical trials from start-up through closeout with minimal supervision.
Oversee CROs, vendors, and cross-functional teams to ensure high-quality, compliant study execution.
Proactively identify risks, drive mitigation strategies, and maintain inspection-ready documentation.
Syneos Health is a leading fully-integrated life sciences services organization that partners with innovators across drug development and commercialization. With over 25,000 employees globally, the company fosters a collaborative, inclusive culture focused on accelerating customer success and patient progress.
Direct strategic change projects across Global Clinical Trial Operations (GCTO) to ensure on-time, high-quality delivery.
Drive cross-initiative change management efforts, including liaising with change agent networks and aligning training plans.
Establish process standards and promote best practices for how teams approach projects and initiatives.
Merck & Co., Inc. is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out.
Lead sponsor-side CRO and vendor management across the full study lifecycle.
Translate study requirements into operational plans and drive study-level strategic decision-making.
Oura empowers people to own their inner potential with award-winning products that provide insights into readiness, activity, and sleep quality. As a quickly growing company, we focus on helping people live healthier and happier lives, ensuring our team members have what they need to do their best work.
Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.
AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.
Lead design and execution of clinical trials for novel antibody-based therapies in rheumatology and I&I diseases.
Collaborate cross-functionally with clinical operations, regulatory, translational science to ensure robust study designs and data quality.
Interpret clinical data and present findings internally and externally, supporting regulatory submissions and scientific publications.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology diseases. As a small, young company, it fosters a fast-paced, collaborative culture focused on advancing meaningful medicines for patients.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
Ensure CTMs have proper resources and training to deliver high-quality study conduct.
Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.
Lead and manage the clinical operations team, setting and executing departmental strategy.
Oversee clinical trial agreements, budgets, expenditures, and ensure timely execution of clinical programs.
Establish and maintain good working relationships with clinical study site personnel and oversee study conduct.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer. The company is pioneering a transformational approach to treating cancer and is committed to continuous innovation in cell therapy, including gene-edited cell therapy.
Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.
Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.
Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.
Provide clinical development leadership at the study level for clinical stage assets in early and/or late development.
Serve as medical monitor for one or more studies and perform ongoing clinical trial data review.
Contribute to clinical development strategy and author clinical and regulatory documents.
Deciphera is a biopharmaceutical company focused on developing new medicines to improve the lives of people with cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Provide strategic leadership and oversight for all clinical data management activities across the development program.
Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
Oversee vendor management, data governance, and delivery of inspection-ready clinical data.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.
Oversee project administration and management of early phase clinical trials for the Pediatric Early Phase Clinical Trial Network.
Manage grants administration, budget oversight, and progress reporting for a $3M+ annual grant.
Lead and mentor a team, ensuring study development and implementation within sponsor timelines.
COG Research Foundation, LLC is a California 501(c)(3) entity that serves as a fiscal sponsor for research programs, providing legal, fiduciary, and administrative oversight. The foundation supports the Children's Oncology Group, which unites over 13,500 experts at more than 220 leading children's hospitals and cancer centers across multiple countries.
Lead and mentor a high-performing team of Clinical Research Associates, ensuring operational excellence and efficient resource utilization.
Manage hiring, onboarding, performance management, and professional development activities for CRA staff.
Collaborate with Project Managers and cross-functional teams to support successful delivery of clinical trials.
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Serve as primary point-of-contact and escalation point for clients, coordinating all functional services and external vendors.
Manage study budgets, project profitability, and billing compliance to ensure financial health and alignment with scope.
Develop robust project plans, track metrics, and prepare status updates for clients and senior management.
Precision Medicine Group is a global contract research organization specializing in oncology and precision medicine. The company values collaboration and quality, employing a diverse team of professionals dedicated to advancing clinical research.
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.
Provide strategic oversight and leadership for a portfolio of complex global clinical trials in dermatology and rheumatology.
Serve as the key client contact, ensuring alignment on objectives, communication, and satisfaction throughout the study lifecycle.
Monitor budgets, timelines, risks, and quality while mentoring project managers and driving operational improvements.
The company is a specialized Contract Research Organization (CRO) focused on dermatology and rheumatology clinical trials. It fosters an international, collaborative, and science-driven environment with a commitment to operational excellence and innovation.