Clinical Development Operations support

• Design, implement, and maintain post-marketing, decentralized, real-world evidence clinical trial platform• Develop specialty pharmacy work flows for patient recruitment• Provide strategic guidance for next-generation software platform• Responsible for protocol and GCP adherence during study conduct• Develop and manage study plan and recruitment forecast to ensure that milestones are achieved on schedule• Oversee subcontracting of ancillary services (e.g. patient recruitment sites, CROs, etc.) • Perform customized end-user training for software platform

• Responsibilities included overseeing conduct of multiple clinical studies for one or more drug program• Managed relationship of pharmaceutical partner and provided strategic guidance on clinical study execution• Revised clinical operations and regulatory Standard Operating Procedures (SOPs), Work Instructions (WIs), forms and templates

• Implemented a scalable clinical operations outsourcing model based on vendor core competencies with an integrated risk mitigation strategy• Successfully rescued a Phase 1 first-in-human oncology study that was failing to enroll patients• Advanced clinical development of two drugs while simultaneously initiating a first-in-human study in another drug• Refined and executed complex biomarker strategy involving the processing of tissue, whole blood, and plasma samples at multiple labs for multiple drug programs• Supported operational aspects of international studies including country-specific import licensing, regulatory submission, patient privacy, and safety reporting requirements• Directed and managed cross-functional teams in the planning and execution of clinical trials from start-up through close-out• Collaborated with internal stakeholders to ensure timelines and budget forecasts were current and accurate• Participated in the authoring, review, and finalization of clinical documents such as protocols, informed consent forms, clinical study reports, pharmacy manuals, and regulatory submissions• Developed and implemented plans to ensure inspection readiness• Supported SOP gap analysis and participated in revision and authoring of SOPs, WIs, forms, and templates

• Managed complex, randomized, multicenter, double-blind, placebo-controlled Phase II study for novel cell therapy addressing acute kidney injury occurring in cardiac surgery patients post cardiopulmonary bypass using principal investigators from multiple disciplines, including intensivists, thoracic surgeons, anesthesiologists, and nephrologists• Supported fully-outsourced study utilizing vendors for data management, statistics, site monitoring, safety, drug distribution, and in-home nursing for a study population that was transitioned from in-patient to home-based setting while on-study

• Oversaw all aspects of clinical trial conduct for a cutting-edge radiopharmaceutical diagnostic and therapeutic compound for the treatment of pheochromocytoma / paraganglioma• Provided general strategic support for all ongoing clinical studies with focuses on vendor management, risk analysis, and data management

• Managed all aspects of day to day operations for two studies: o Phase III study for activated macrophage solution for the treatment of chronic diabetic wounds o Pivotal study for combination device / biologic product for posterolateral spinal fusion procedures• Functioned as primary sponsor study contact for all study-related activities, and accountable for internal departmental study leads' performance• Responsible for ensuring the quality of clinical projects, and that they were conducted according to ICH/GCP, Averion and/or Sponsor SOPs, guidelines, and requirements• Collaborated on the management of site monitoring, database development and maintenance, data management and entry, programming, safety, statistics, report writing, and agency presentations• Authored and reviewed study documents to ensure quality standards were met (e.g. Protocol, Case Report Forms, Monitoring Plan, Data Management Plan) • Proactively identified issues and developed solutions for assuring study timelines and budgets were met without compromising quality deliverables• Generated monthly status reports reflecting each aspect of the clinical project’s progress, and used to provide Sponsor with timeline and budget forecasting• Developed and oversaw investigational product supply and distribution processes• Performed investigational site selection per sponsor requirements and according to approved budget and timeline• Provided review of investigational site contracts, budgets, and informed consents to ensure consistency and adherence to study-specific and regulatory requirements• Led third-party vendor selection activities according to requirements defined in sponsor contract

• Oversaw internal and external project activities including project timelines and budgets, to ensure study execution was in accordance with regulations, GCP, and corporate standards• Managed vendors, investigative sites, senior management deliverables, cross-departmental clinical communications• Coordinated and communicated project activities; produced project status reports; conducted project meetings• Reviewed vendor requests for proposals, scopes of work, budgets, and operating procedures• Directed investigator recruitment and selection; conducted investigator and site staff training• Managed reporting of serious adverse events to safety medical monitor and to regulatory agencies• Authored standard operating procedures, work instructions, and participated in cross-divisional team meetings for revising clinical affairs standards

• Managed all aspects of in-house clinical trials, including oversight the activities of medical writing, clinical data management, biostatistics, drug supply, regulatory, independent contract site monitors, central laboratories, central reading centers, central institutional review boards, interactive voice/web response system provider• Collaborated with the medical director and biostatistician to design clinical trials that were in alignment with the clinical development plan and that maximized a study’s potential• Assessed feasibility of clinical sites (e.g. design, size, location, site staff experience, and patient population) to determine probability of success in clinical trial participation• Ensured clinical trial conduct was in compliance with good clinical practice, country-specific regulations, and corporate standard operating procedures• Reviewed all vendor requests for proposals, scopes of work, budgets, and operating procedures• Led periodic reviews of study data to ensure that the correct patients were recruited, data trends were detected, and study objectives were met• Projected and tracked patient recruitment, and developed contingency plans to ensure target enrollment was met• Worked with departmental members, as well as across functional groups, in the development of study-related documents (e.g. study synopses, study reference guide, regulatory binder, case report forms, model informed consent, monitoring plan, pharmacy guideline, statistical analysis plan, drug handling and administration instructions)• Developed, tracked, and ensured adherence to clinical trial timelines and budgets• Participated in non-study related initiatives such as clinical quality improvement program, implementation of remote data capture technology, and development of patient enrollment algorithm to improve accuracy of recruitment forecasting

• Conducted site visits, including site qualification, initiation, monitoring, and close-out• Performed site training, source data verification, study drug accountability, regulatory binder review, and assisted in data query management• Co-monitored with contract monitors to ensure their quality and compliance

• Acted as lead clinical data manager on multiple studies concurrently, performing all data management functions from study start-up to close-out, including developing data management plans, designing case report forms, specifying edit checks, issuing and integrating data queries, tracking case report forms and queries, authoring audit plans, coding medical terms, and reconciling the serious adverse event and clinical databases• Managed all data management activities performed by contract research organizations and external vendors supplying data, including negotiating scopes of work, budgets, and timelines• Played a key role in the implementation of electronic data capture technology, and spear-headed process and documentation improvements associated with the system

• Designed electronic case report forms, specified edit checks, developed validation plans and test data, annotated electronic case report forms, specified mappings for sponsor specific data tables, converted protocols and case report form instructions into HTML• Simultaneously managed multiple sponsors and trials in various life-cycle stages, including study start-up, change-orders, and study close-out, and assisted sponsors in creating new work-flows associated with the deployment of electronic case report forms• Solely responsible for implementation of new patient diary technology, including the creation of specifications, work-flow, and validation processes

• Performed all data management functions from study start-up to close-out, including designing case report forms, authoring case report form guidelines, specifying edit checks, designing data entry databases in SAS, programming and validating edit checks, manually reviewing data, issuing and integrating data queries, tracking case report forms and queries, authoring audit plans, and reconciling the serious adverse event and clinical databases• Managed data management timelines and budgets, acted as principal data management contact for sponsors, collaborated with internal clinical operations and statistical teams in the execution of studies• Trained and mentored new hires, authored new work instructions and standard operating procedures, developed and implemented new technologies