Elizabeth Keane Email & Phone Number

Boston, Ma, Us

Waltham, Massachusetts, Us

[Mural Oncology split from Alkermes in November 2023]Directs operations, clinical strategy, execution and delivery for 5 studies within an oncology program with $250M in operating expenses. I drive strategic planning and guide best practices, collaborating across the organization to ensure studies meet regulatory requirements, project milestones are achieved, budgets are optimized, and study start up and operations are successful. I establish strong relationships with key stakeholders, CROs, partners and vendors and align study performance goals and targets with cross-functional teams in clinical development, biostatistics, medical affairs and translational medicine. Represent the organization at industry conferences. I lead, mentor and develop 2 clinical trial managers.Highlights include:• Successfully initiating a Phase 3 international ovarian cancer study with multiple stakeholders and external collaborators, and transitioned to a new CRO during active trial while maintaining study timeline and deliverables. • Being recognized with Alkermes IMPACT “silver” award for going above and beyond to support company’s mission in 2021. • Ensuring business continuity and successfully maintaining study operations during multiple leadership transitions, leading to selection to leadership team for clinical development operations in 2022.

Dublin, Ie

As a key member of the clinical team, led operations, planning and execution of clinical studies within the R&D portfolio including schizophrenia and opioid use disorder programs. I managed project design, feasibility, country selection, budgets and timelines and performance tracking. I created, monitored and analyzed study performance metrics, evaluated and selected vendors and oversaw CROs, established partnerships, managed relationships and negotiated contracts. Managed a team of trial managers and associates.Achievements included: contributing to data integration and technology initiatives, collaborating with data management and supply chain teams to implement IVRS and ePro and streamlining workflow. Clinical Program Manager2017 - 2019Senior Clinical Trial Manager2012 - 2017Oversaw conduct and execution of Phase 1 through Phase 4 clinical studies, managing timelines, key deliverables, CROs and vendors and ensuring programs met critical goals. I provided project status and reporting to key stakeholders and senior management, and communicated across multidisciplinary teams to resolve challenges and facilitate progress. Managed and developed a clinical trial manager and clinical trial associate. Successes included:• Coordinating department training for standard operating procedures and contributing to annual company-wide curricula review to ensure compliance with SOPs. • Being a key member of the team that successfully completed a Phase 3 global study for schizophrenia, resulting in FDA product approval and subsequent approvals for sNDAs. • Effective recordkeeping and trial process communication to ensure FDA inspection readiness. Clinical Operations Specialist II2010 - 2012Clinical Operations Specialist I2008 - 2010

Us

I supported execution of two Phase 3 multicenter, international echocardiographic imaging clinical trials. I collaborated with the CRO and cross functional team on the design of CRFs and study tools, conducted site qualification, study initiation, monitoring and close-out visits and ensured compliance with study protocols, company procedures, GCP and Federal regulations. Provided ongoing communication and reported on study progress to project stakeholders and CROs. Together with a project manager, I supervised a team of European-based contract CRAs. Achievements included:• Initiating reviews and updates for department SOPs, study consent forms and documentation, collaborating with clinical operations team to ensure completeness and accuracy and facilitating workflow efficiencies. • Contributing to development and implementation of grant programs for clinical sites. • Being recognized for excellence with “Top 10 Performer” awards. Clinical Research Coordinator2007 – 2008Administrative Assistant, Clinical Research2000 – 2003