Independently manages the study start up activities for multi-center, US and/or global based studies.
Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the immune system, and are committed to continuous innovation in cell therapy.
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.
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.
Take ownership of clinical project delivery, ensuring contracted deliverables are met while managing quality, timelines, and budgets.
Lead communication and collaboration with clients, project managers, functional leads, vendors, and clinical teams worldwide.
Mentor team members, use data-driven tools to anticipate risks, and drive continuous improvement in study execution.
Our partner is a specialized clinical research organization focused on advancing pharmaceutical and medical device development. They foster a multicultural, matrixed environment emphasizing quality, collaboration, and innovation.
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.
Lead strategic development and continuous evolution of the Medical Information function to support COMP360 and pipeline assets.
Oversee development of compliant medical information response documents and collaborate cross-functionally to ensure alignment.
Establish scalable capabilities, metrics, and innovation in technology and service delivery to enhance operational excellence.
Compass Pathways plc is a biotechnology company dedicated to developing new treatment options in mental health care, with a focus on COMP360 psilocybin for treatment-resistant depression and PTSD. The company is headquartered in London, UK, with a US office in New Jersey, and leads one of the largest clinical programs in psychedelic treatments.
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.