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.
Absci is a clinical-stage biotechnology company leveraging generative AI for drug discovery through its Integrated Drug Creation platform. The company has a global presence with offices in the US, Switzerland, and Serbia, and fosters a collaborative, innovative culture.
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.
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.
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.
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.
Manage clinical operations including study management, biospecimen acquisition, and regulatory compliance.
Lead and mentor a team of CRAs and clinical trial logistics personnel.
Develop and implement processes and tools for high-quality trial management.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to delivering better solutions and have an innovative culture focused on collaboration and cutting edge solutions.
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.
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.
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.
Provide therapeutic and operational leadership throughout the clinical program and project delivery lifecycle.
Collaborate with cross-functional teams to develop effective delivery strategies and resolve operational challenges.
Ensure clinical projects within the assigned franchise are appropriately resourced and aligned with operational goals.
Our partner is a global clinical research organization dedicated to advancing healthcare innovation and improving patient outcomes through high-quality clinical trials. They offer a collaborative and inclusive environment with experienced professionals across global therapeutic and operational teams, focusing on professional growth and meaningful impact.
Independently negotiate and manage complex clinical trial agreements, site budgets, and amendments with minimal training.
Partner cross-functionally with Clinical Operations, Finance, and Legal to ensure compliant and timely study startup.
Serve as subject matter expert and escalation point for contract and budget issues across global studies.
CareDx is a leading precision medicine solutions company focused on improving outcomes for transplant patients through innovative diagnostics, services, and digital health solutions. As a leader in genomics-based transplant information, the company offers a competitive Total Rewards package and fosters a mission-driven culture where employees directly impact patient lives.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Act as a strategic partner for key customers, leading governance, growth initiatives, financial performance, and cross-functional collaboration.
Lead and oversee global, multiregional, or complex regional Clinical FSP partnerships, ensuring alignment with contractual agreements and strategic priorities.
Provide executive oversight for clinical FSP delivery, ensuring quality, timelines, key performance indicators, and contractual commitments are achieved.
The employer is a global clinical research organization that partners with pharmaceutical and biotech companies to deliver clinical trials. They are a large, established company with a culture focused on innovation, collaboration, and advancing healthcare worldwide.
Set strategic direction and lead large clinical trials and data collection efforts.
Manage clinical research operations, including site selection, budgets, and regulatory compliance.
Author publications and represent the company at major annual conferences.
Hanger is the world's premier provider of orthotic and prosthetic services and products, offering advanced solutions and clinical programs. With 160 years of history, the company operates nationwide clinics and employs thousands, focusing on empowering human potential through superior patient care.
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.
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.
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.
Acts as primary point of contact for investigative sites, providing training and support to ensure compliance with protocols and regulations.
Conducts site evaluation, monitoring, and closure activities while managing recruitment and retention plans based on patient journey.
Collaborates with central monitoring to assess risks and ensure data quality, safety reporting, and audit readiness at assigned sites.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, and neuroscience. It is a large pharmaceutical company with a global presence and a culture focused on remarkable impact.
Lead the strategy and execution of oncology site relationship development and engagement initiatives for clinical trials.
Build and strengthen long-term partnerships with key clinical research sites and networks using data-driven approaches.
Collaborate with cross-functional teams to incorporate site insights into trial strategies and present engagement plans during client meetings.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They process applications and share shortlists with employers, focusing on efficient and objective recruitment.
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.