Manage day-to-day clinical trial operations, including CRO/vendor oversight and site management.
Lead cross-functional study teams, develop study documents, and implement risk mitigation strategies.
Ensure high-quality deliverables within timelines and budget, from start-up through close-out.
Ultragenyx is a biopharmaceutical company dedicated to developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture focused on learning and growth, with a global team committed to innovation.
Manage operational activities for all phases of clinical studies, from start-up to close-out.
Provide sponsor oversight of CROs and vendors to ensure compliance and quality.
Support data review, TMF maintenance, and cross-functional collaboration for trial success.
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing off-the-shelf cell therapies for devastating diseases. The company fosters an open, collaborative culture where diverse perspectives are welcomed, with teams working from Berkeley or remotely.
Support operational execution of clinical studies from initial synopsis through final deliverables.
Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
Oversee cross-functional study teams and ensure compliance with regulations and data integrity.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.
Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
Manages external vendors, recruitment strategies, and cross-functional team coordination.
Maintains inspection readiness and contributes to risk management and process improvement.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
Support program-level compound training and mentor new team members in Trial Management.
Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.
Oversee strategic planning and execution of global clinical studies.
Manage internal and external resources, including CROs, to ensure quality and compliance.
Lead cross-functional teams and contribute to trial design and budgeting.
Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.
Lead and manage a team of Project Directors and Project Managers for global clinical trials.
Oversee project delivery, sponsor interactions, and profitability across clinical programs.
Ensure compliance with GCP/ICH and drive continuous improvement and KPIs.
Precision Medicine Group is a precision medicine company providing clinical research and development services. They emphasize quality, people, clients, and performance, with a collaborative team environment.
Identify, source, and manage clinical vendor relationships to support study objectives and cost-effective procurement.
Review clinical protocols to determine vendor scope, lead RFPs, and negotiate contracts with legal and finance teams.
Monitor vendor performance, resolve issues, and drive continuous improvement across clinical operations.
Care Access brings world-class clinical research and health services directly to communities, with hundreds of locations and clinicians globally. They are dedicated to building a more accessible future of health, emphasizing people at the heart of medical progress.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
Design and implement scalable operational processes across sales, marketing, customer success, and clinical teams.
Build and optimize commercial playbooks, CRM workflows, and reporting to drive business growth and efficiency.
Lead cross-functional strategic projects and executive presentations to support organizational expansion and market leadership.
They are a rapidly growing healthcare technology organization focused on improving patient outcomes through scalable technology solutions. The company culture is collaborative, mission-driven, and emphasizes innovation, learning, and professional growth.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.
Lead global Pharmacovigilance Operations, Quality & Compliance strategy to ensure scalable, inspection-ready systems.
Oversee case processing, vendor governance, PSMF, quality systems, audits, and regulatory inspections.
Build and mentor a global team, collaborating cross-functionally to support portfolio growth and commercialization.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.
Provide strategic and operational leadership for Immunome's clinical trial monitoring function, including implementing contract field monitoring team and standardizing monitoring strategy across the oncology portfolio.
Lead and develop a high-performing field monitoring function, partnering closely with Clinical Site and Trial Operations, Data Management, and Quality to ensure data quality and patient safety.
Manage monitoring budgets, resources, and vendor oversight, ensuring compliance with ICH-GCP, FDA, EMA regulations and driving inspection readiness.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. They have a leadership team experienced in design, development, and commercialization of cutting-edge therapies including antibody-drug conjugates.
Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.
Manage global, multi-center clinical research projects in various therapeutic areas.
Deliver projects on time, within budget, and to high quality standards while leading multifunctional teams.
Serve as primary client contact, participate in bid defenses, and ensure compliance with procedures.
PSI is a leading Contract Research Organization with 30 years of experience in the industry, offering a balance between stability and innovation. We focus on delivering quality and timely services across various therapeutic indications, investing in our people's professional development.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Identify and source clinical vendors through market research and protocol analysis.
Lead contract negotiations and vendor selection to ensure cost-effective procurement.
Manage vendor performance and compliance, serving as the escalation point for issues.
Care Access is 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, we put people at the heart of medical progress.