Lillian (Lilly) Frohlich Email and Phone Number

• Lead Study Management Teams for two Phase I studies and one Phase III study, with cross functional stakeholder alignment and ability to drive team and CRO against contracted budget and timelines• Proactively and independently manage vendors, including identifying risks and outlining mitigation plans• Build and manage study budgets• Develop risk based and study based approach to site and monitor oversight• Provide operational oversight to assigned clinical trials, including protocol development, study plan generation, supply logistics, and issue resolution• Provide leadership to multifunctional study management teams and acts as main point of contact for CRO on study progress, issues, and mitigation plans• Provide oversight to study support staff• Actively participate in initiatives and process improvements contributing to functional excellence in Trial Operations

• Supported the delivery of clinical studies under the direction of the Clinical Trial Lead• Assisted and led the development of project related documentation, coordinated project tasks, and communicated progress to team members for assigned projects• Created tracking mechanism and oversight of assigned vendor deliverables (vendor plans, study documents, etc.)• Provided oversight of CRA monitoring reports, with escalation of key concerns as necessary to the Clinical Trial Lead• Receipt, tracking and triage of study informed consents requiring internal review• Oversight of Trial Master File for assigned studies, including completeness checks, and audit readiness preparation• Provided critical input to Project Management for proactive resolutions and improvements

• Provided support to Manager, Clinical Trial Manager, and Clinical Operations department as appropriate• Assisted in the development of Clinical Trial related documentation, such as informed consent forms, study manuals and tools, subject recruitment materials, clinical trial protocols, including updates and amendments• Provided oversight of CRO and third-party-vendors, including set-up, logistics, documentation, and clinical supplies needed for clinical trials• Planned and executed Investigators’ Meeting for Global Phase III studies• Developed and implemented a process for Informed Consent form development, localization, and review across clinical trial portfolio• Conducted quality review of data outputs• Ensured cross-function alignment and oversight of ongoing Clinical Trial activities• Procured and maintained Clinical Trial Insurance across clinical trial portfolio• Provided oversight of the Trial Master File maintenance and overall health

• Facilitated cross-functional alignment amongst clinical development teams and external stakeholders• Provided support to Director of Clinical Operations Sciences to drive efficiency and consistency across programs• Identified interdependencies and synergies with other trials within Clinical Development Team programs and sought to proactively develop a process to enhance excellence in execution across studies• Worked cohesively with and provided guidance to study-level CTCs• Utilized and maintained appropriate study and program tracking and forecasting tools (budget, timeline maintenance and projection, and enrollment)• Maintained study-level clinical trial insurance across Biogen• Conducted a review of core study documents and processes across the program to identify and improve any inconsistencies (e.g., IFP, site reference materials, TMF review plans, communication plans, monitoring conventions etc.)

• Responsible for coordinating over 12 clinical research studies, including screening, recruiting, and enrolling study participants• Maintained study documents and patient files• Completed study Case Report Forms and perform data entry and reported to study sponsors• Assisted in writing study manuscripts• Calculated recruitment and retention statistics• Assisted Principal Investigators in study procedures• Worked cohesively with other study coordinators, physicians, nurses, and clinical assistants in the Emergency Department

• Aided in the writing of grant proposals• Aided in the development and implementation of Safe Kids Upstate NY programs and events• Collaborated with SIDS experts to create a ‘Safe Sleep’ education program for mothers of newborns in all Syracuse area hospital

• Shadowed ophthalmologist & optometrists • Aided medical technicians with patient testing & surgical consulting• Assisted administrative staff with daily tasks including answering phones & emails, booking & confirming appointments, & verifying patient insurance• Managed Practice social media and marketing