Ellen Rocca Email & Phone Number

Remote (Nj)

Accountable for the successful conduct of site monitoring and TMF Operations activities across all Prothena studies.-Provide oversight and leadership to TMF Operations team to ensure TMF completeness, accessibility, quality, and compliance; activities include process development, inspection readiness review, training, and business system ownership.-Developed oversight strategy for organization to ensure effective site monitoring, including review of documentation from site visits (i.e., monitoring visit reports and follow-up letters) and execution of monitoring oversight visits. -Lead direct reports to ensure Monitoring and TMF Operations activities support the overall study plan with respect to timelines, cost, and quality.-Create and deliver new hire orientation materials such as onboarding presentations and supportive tools, a mentoring program, and new hire checklists.-Lead Clinical Trial Liaison team in implementing site relationship management and patient recruitment.

Accountable for effective execution of global clinical monitoring, patient recruitment, and study start up activities within established corporate timelines.-Manage people managers; recruit, hire, manage, and mentor direct reports and support their professional development, ensuring strong leadership and delivery through all levels of the team.-Oversaw line function performance and established KPI’s for study start up, recruitment and monitoring for successful delivery of global development portfolio.-Build and lead in-house study start up capabilities to improve site selection, qualification, and contract/budget negotiations timelines to accelerate time to site initiation and activation.-Deliver regional monitoring resource model to optimize productivity and ensure quality monitoring in preparation for site/sponsor audit activities.-Active participation and leadership in global clinical operations and cross-functional organizational initiatives to drive improvements in efficiency and operations.-Partner with Global IT to implement key systems and tools to advance the Clinical Operations delivery platform, including CTMS, eTMF, RBQM and related technology. -Responsible for the creation of departmental SOPs and process documents and ensure quality delivery and execution to ICH/GCP guidelines; active participation in cross-functional process improvement initiatives. -Develop risk-based monitoring strategy; manage implementation, including tools/resources needed for execution within timelines established.

Responsible for study-level risk management activities including determination of critical processes/data; identification, evaluation, control, review, and reporting of risks; implementation of central monitoring; and facilitation of Quality Tolerance Limits (QTLs).-Lead discussion regarding risk/issue management and monitoring strategy across line functions and within project team, including COVID-19 risk mitigations such as remote monitoring and decentralized processes.-Oversee functional area risk management activities.-Improve Shionogi risk management processes (use of lessons learned, updating SOPs, and creating standards) and implement new systems/procedures/tools related to risk management.-Create training materials and deliver training courses on risk management practices in clinical trials.-Act as main point of contact for CRO on all risk management activities, including centralized monitoring and QTLs.

Responsible for accurate and compliant execution of Clinical Monitoring activities across PPD clinical portfolio.-Supervise and coordinate Clinical Monitoring functions, including mentoring managers in day-to-day activities and responsibilities related to the clinical deliverables with a focus on quality.-Oversaw 9 Line Managers with a staff of >150 Clinical Research Associates and Remote Site Monitors.Manage clinical resource levels and participate in resource calls to ensure teams are provided with adequate levels of appropriately qualified resources.-Ensure staff is trained and mentored according to company policies and procedures as well as develop, implement and review key performance metrics.-Lead Global Risk-based Monitoring change management team for Clinical Monitoring to ensure appropriate stakeholder management, training, communication, and execution.-Participated in multiple bid defense meetings for clients and responsible for Monitoring oversight of several key clients.-Responsible for the conduct of North American face-to-face and virtual training meetings all Clinical Research Associates and Remote Site Monitors.

Home Based

Coordinate change management and communications across all Medical Affairs technology projects including stakeholder engagement, organizational alignment and training, and performance support to attain rapid worldwide user adoption.-Serve as chair of business and technology governance committees to provide program oversight, operational support, and infrastructure to realize benefits of new solutions and capabilities.-Lead for multi-solution platform that enables diverse Medical Affairs activities.-Responsible for the business ownership, development, training delivery, and overall management of the Investigator Initiated Trials (IIT) solution.-Global, cross-functional interaction within and beyond Medical Affairs to ensure optimized processes, best practices, consistent performance, and quality related to information maintenance and reporting.

Head of Trial Master File and centralized services within Clinical Operations including essential document management, study start-up and clinical systems ownership. -Responsible for the strategic planning and implementation of requirements, systems, and processes for handling, filing, storage and archiving of essential documents.-Lead TMF governance board in cross-functional meetings to ensure essential document inspection readiness, consistent quality of TMF information and process improvements.-Directed the planning, leadership, and deliverables of the Central Services support team globally to manage centralized activities across clinical studies such as study start-up, IRB/EC submission and safety report distribution. -Business owner of multiple clinical systems including the CTMS, safety event distribution portal, electronic TMF, centralized document repositories, and site facing learning management system.-Responsible for resourcing management, training, performance, and development of Central Services and TMF teams.

Accountable for execution of study management and vendor oversight for multiple clinical studies. -Supervise various levels of Clinical Trial Management staff including hiring, resourcing, training, and performance management.-Develop orientation programs for new employees and oversaw their training and transition to the company to ensure better-prepared employees. -Direct implementation of the New Jersey satellite office, ensuring no delays in executing procedures and policies from the head office. -Spearhead development of a Working Practice manual for process improvement and execution.

Florham Park, Nj

Accountable for conduct of accurate and timely study support deliverables.-Responsible for hiring, management, and resourcing of in-house Clinical Operations support professionals and ensuring adequate training and development of direct reports.-Compose departmental SOPs; provide training/oversight to ensure compliant execution.-Provide project support oversight to clinical studies, including timeline management and participation in cross-functional study teams.-Oversee the maintenance, security, and quality control of the TMF to stay compliant with company guidelines, FDA regulations, and GCPs.-Develop and deliver presentations on multiple Clinical Operations topics to internal and external audiences.-Designed and implemented the CTMS for all study activities.

Master Of Science In Jurisprudence, Health Law And Policy

Bachelor Of Science In Nursing, Nursing

Activities and Societies: Sigma Theta Tau - Nursing Honor Society President Student Nurses Association