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Click here or scroll down to respond to this candidateCandidate's Name
Woodinville, WA Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLEPROFESSIONAL SUMMARYProactive, resilient dedicated pharmaceutical global Project Manager with 18+ years of progressive experience in clinical research and the drug development process (pharmacokinetics, pharmacodynamics, first in human, biologics, targeted therapeutics, cancer vaccines, medical device, adaptive trial designs, accelerated drug development, formulation changes, registrational trials & post-marketing commitments). Wide breadth and depth of research experience across roles, functions, geographies, and organizations and indications. Initiative- taking individual with strong interpersonal and organizational skills. Resilient and adaptable in an ever- changing environment. Self-directed, lifelong learner through active membership in several professional development organization. Currently working on Lean Six Sigma completed my Green Belt 3/2024. Virtually attending University of Washington to obtain a certificate in Biotechnology Project Management anticipated data of completion 10/2024. Studying for my certificate in Project Management (PMP) / Program Management(PgMP) plan to site for the exams in Nov 2024.SKILLS Project management expertise - Ph1- IV,NHV, Special Populations renal and hepaticpost-marketing studies. Enjoy engaging with managing key projects,stakeholders, and personnel, such as,researchers, scientists, health care consultantsand physicians as well as the oncologyleadership team and board of directors. 5+ years CRA monitoring experienceincluding risk-based monitoring. Currently manage a cross functional coreteam of 6-8 people that report to me as well as8-vendors. Exceptional trainer internal / external Continuously demonstrate ethics and integrity Strong technical and professional writing andpresentation skills. Adept in budgeting, forecastingcritical thinking, analytical decision-making,and problem-solving. Experience contributing to virtual FDA meetings(i.e. Type C) as well as Health Canada meetings. Extensive audit experience; internal, clinicalsites, FDA, Health Canada (including 1-forcause audit) and EMEA. Ability to successfully manage multiple projects across multiple time zones. On time and on budgetby going above and beyond, leading by example,,active listening, developing flexibility, empathycoaching, and mentoring. Advanced proficiency with MS Office,PowerPoint, SharePoint, Kanban, Excel, MSProject, Veeva RIM, Veeva Vault, CTMS, RAVEViso, 4G, Mural Advance training and direct clinical trialexperience as a nurse practitioner, in oncology as well as other therapeutic areas such as womenshealth, diabetes I / II, COPD and chronic plaquetype psoriasis. Participated on a subcommittee that successfully completed GDPR compliance in 2021. Timely project completion establishing andmaintaining timelines for drug trials andensuring proper, compliant completion ofeach one. Maintaining detailed records on the progressof research, trials, and approvals from onephase to the next, in accordance withregulatory mandates and corporategovernance rules. Excel at building relationships by contributingto and attending congresses, advisory boards,KOL meetings and investigator / coordinatormeetings. Building proactive, collaborative partnershipswith vendors responsible for the fulloversight of multiple vendors includinggovernance and KPIs Comprehensive understanding of andcompliance with global regulatory guidelines. Recent experience with FDA, PMDA, HC, EU,UK, and TGA (Australian) clinical trialsubmissions. Motivation to always be flexible, agile, andadaptable to change while. Effective at modeling white glove service forour clinical sites. Leading by example. Alwaysstriving to be the sponsor of choice throughsuperior customer service and support. Active contribute to a sub-committee exploringdiversity plans to improve enrollment ofparticipants from underrepresented racial andethnic populations in clinical trials.WORK HISTORYSr Global Clinical Project Manager, 10/2019 - Current Sumitomo Pharma America Cambridge, MA Currently managing a global myelofibrosis study with 75 sites in 10 countries Managed global expansion in multiple countries enabling footprint expansion and improved recruitment. Manage Healthy Normal Volunteer (NHV) studies as part of formulation development. Promoted high morale through dynamic communication, prompt problem resolution, proactive oversight practices and facilitation of positive work environment. Successful management of multiple vendors needed to accomplish project goals. Analyzed project performance data to identify areas of improvement. Developed and implemented project plans to ensure successful execution. Monitored project progress, identified risks, and took corrective action as needed. Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules, and conflicts. Maintained open communication by presenting regular updates on project status to Executive Management. Skilled at working independently and collaboratively in team environment. Developed strong organizational, leadership and communication skills. Proven ability to learn quickly and adapt to new and dynamic situations. Passionate about learning and committed to continual improvement. Proven success working within tight deadlines and fast-paced, dynamic environment. Co-lead of cross functional team that includes representatives from, clinical development, CMC, regulatory, clinical operations, medical affairs, business operations, research, and development. Launched study coordinator and investigator meetings at two major conferences in past year to support clinical sites, boost recruitment and increase company visibility. North American Project Manager II, 05/2019 - 09/2019 PRA Health Sciences Toronto, Ontario Worked with Beigene pharma on a hematology - oncology trial. Met project deadlines without sacrificing quality. Identified plans and resources required to meet project goals and objectives. Provided detailed project status updates to stakeholders and executive management. Prepared and submitted project invoices for review and approval. Coordinated with cross-functional teams to resolve project issues and mitigate risks. Reported regularly to managers on project budget, progress, and risks. Monitored project progress, identified risks, and took corrective action as needed. Maximized performance by monitoring daily activities and mentoring team members. Clinical Operations Manager & CRA Line Manager, 05/2017 - 04/2019 Syneos Health Toronto, Ontario Ensured operational consistency and quality across group of studies that were awarded by Sumitomo Pharma America Completed 3-studies on time. Successfully locked databases per agreed timelines Defined by scope provided leadership, mentoring and technical support to Clinical Operations team to ensure quality of deliverables. Used critical thinking to break down problems, evaluate solutions and make decisions. Excellent communication skills, both verbal and written. Organized and detail-oriented with strong work ethic. Demonstrated high level of initiative and creativity while tackling difficult tasks. Passionate about learning and committed to continual improvement. Managed continuous improvement initiatives to drive gains in quality, flow, and output. Handled job duties for staff members which were unavailable or out of office. Wrote and conducted formal performance reviews for direct reports. Provided administrative line management, which included oversight of training, compliance, performance, career management and development of direct reports. Evaluated employee performance and provided feedback and training as needed. Lead Clinical Research Associate, 05/2015 - 05/2017 Chiltern Raleigh-Durham, NC Provided expert advice, guidance, and general supervision to Clinical Monitoring team activities for designated projects. Monitored specific sites to ensure quality and integrity of data, compliance with Chiltern International or Client's SOPs, ICH, GCP, regulatory requirements. Delivery of protocol specific training to; CRAs and other team members as appropriate Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns. Distilled large amounts of information and produced reports, spreadsheets and documents outlining key details. Participated in business development proposals, defense meetings and proposal development. Successful in winning 4-bids bringing this work to Chiltern. Participated in auditing program to address risks and evaluate compliance with regulatory requirements. Communicated with audit staff to obtain necessary information for audits. Adapted plans and schedules to meet changing priorities of work objectives, resources and workload demands. Performed observations and evaluated supporting documents to supplement audit findings. Senior Site Manager, 02/2013 - 07/2014InVentiv Health Mississauga, Ontario In-sourced to Roche Canada in the role of Clinical Trial Monitor / Site Manager Dedicated to oncology clinical trials. Monitored using a Fit-for-Purpose / Risk Based Monitoring Model Responsible for all aspects of site management including training, monitoring, document collection and oversight. Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. Maintained compliance with protocols covering patient care and clinical trial operations. Developed and maintained courteous and effective working relationships. Provided professional services and support in a dynamic work environment. Organized and detail-oriented with a strong work ethic. Associate Project Manager - Special Populations, 07/2011 - 02/2013 Celerion West Conshohocken, PA Project management support for early clinical trials conducted in special populations (renal, hepatic conducted as part of post-marketing commitments). Supported senior managers and department leaders by completing projects and problem resolution under tight budgets and schedule demands. Partnered with project team members to identify and quickly address problems. Delivered high level of service to clients to both maintain and extend relationship for future business opportunities. Monitored and tracked project metrics and collected data to share with project members. Identified and resolved risks to minimize project disruption. Reported regularly to managers on project budget, progress, and technical problems. Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules, and conflicts. Developed and implemented project plans and budgets to ensure successful execution. Director / Owner, 11/2007 - 02/2011MedSci Clinical Consulting Hamilton, ON Succeeded in conducting numerous non-oncology trials including; chronic plaque type psoriasis, acne, eczema, womens health contraceptive pill, Diabetes T2. Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality. Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues. Conducted clinical trial in accordance with protocol and recorded and monitored progress. Applied extensive ICH GCP knowledge to troubleshoot and resolve regulatory document issues. Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion. Conducted meetings with sponsor representatives to discuss clinical study developments. Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials. Reviewed data queries and listings and worked with study centers to resolve data discrepancies. Conducted initiation, monitoring, and closeout visits to verify study procedures, regulatory documents, and data completion. Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication. Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.Associate Project Manager, 09/2006 - 11/2007Ontario Oncology Group - McMaster University Hamilton, ON Delivered high level of service to investigators to both maintain and extend relationship for future collaboration opportunities. Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets. Monitored and tracked project metrics and collected data to share with project members. Identified and resolved risks to minimize project disruption. Facilitated workshops to collect project requirements and user feedback. Implemented diverse instructional methods, optimizing staff engagement. Championed new initiatives and developed training material to support the move from paper case report forms to electronic data capture. Administered assessments before, during and after courses. Edited and proofread technical documents for accuracy and consistency. Identified and leveraged resources to understand underlying science and project strategy. Associate Project Manager - MaRS Tumor Bank, 01/2005 - 09/2006 McMaster University Hamilton, Ontario Accountable for set-up and day-to-day operation of a biobank Facilitate the collection, processing and storage of human tissue, peripheral blood, and derivative products with de-identified clinical data. Used critical thinking to break down problems, evaluate solutions and make decisions. Adaptable and proficient in learning new concepts quickly and efficiently. Resolved problems, improved operations, and provided exceptional service. Cultivated interpersonal skills by building positive relationships with pathology, operating room and surgical staff. Learned and adapted quickly to new technology and software applications. Produced training manuals, presentations, and resources for enhanced learning. EDUCATIONSix Sigma Global Institute (SSGI) Jan 2024 Ongoing University of Washington Certificate in Biotechnology Project Management. Seattle, WA 03/2024 OngoingMcMaster University - Hamilton, Ontario 02/2002Advanced classes in nursing BScNBachelor of Arts Gerontology & Psychology: 09/1992 06/1995 McMaster University - Hamilton, ONDiploma Nursing Registered Nurse: 09/1986 - 04/1989 Mohawk College - Hamilton, ONCertificate - Project Management, 02/2007PUBLICATIONSGoldlust, S., Chang, J. H., Narita, Y., Welch, M., Green, R. M., Drappatz, J., Piccioni, D., Kim, Y. J., Melear, J. M., Tanaka, S., Wei, K., Fink, K., Pitz, M., Cloughesy, T. F., De Groot, J. F., McClellan, N., Hitron, M., Xu, B., Jin, B., & Lebedinsky, C. (2023). Ombipepimut dosing emulsion (ODE) + bevacizumab (bev) vs bev alone in patients (pts) with recurrent or progressive glioblastoma (rGBM). Journal of Clinical Oncology, 41(16_suppl), 2022. https://doi.org/10.1200/jco.2023.41.16_suppl.2022 Elavathil, L. & Goulbourne, M. & Zaidi, A. & McClellan (Howatt), N. & Ceballos, K. & Tadross, O. & Gohla, G. & Aziz, T. & Strang, B. & Dhesy-Thind, S. & Lytwyn, A. (2007). Tertiary center breast cancer pathology review: Positive impact on patient care. 30A-30ALytwyn, A. & Hodgson, N. & Hileeto, Denise & Bacopoulus, S. & Browing, D. & McClellan, N. & Elavathil, L. (2007). Adenoid cystic carcinoma of the breast: Frequent margin involvement after primary surgery. 40A- 40A.Elavathil, Leela & McClellan, Nanci & Hirte, Hal & Singh, Gurmit & Zanke, Brent & Kodeeswaran, Sugy & Mishra, Amrita & Lytwyn, Alice. (2006). Ontario tumour bank initiative at Hamilton Health Sciences and the Juravinski Cancer Centre. 52-52.AFFILIATIONSWomen Leaders in PharmaFeb 2023 - PresentWomen In Bio (WIB) SeattleFeb 2023 PresentProject Management Institute Member & Member of PMI Puget Sound Chapter Feb 2022 Present \Active Member Association of Clinical Research Project Managers (CRPM Association) Toastmasters Virtual Leading Ladies Washington State June 2024CRO Steering Committee Member - American Association of Pharmaceutical Scientists (AAPS) 2012-2013Appointed to the Ethics and Public Policy Committee of the Association of Clinical Steering Committee Member - American Association of Pharmaceutical Scientists (AAPS) -2012 -2014Past Member of the Canadian Association of Research Ethics Boards (CAREB) Ottawa, Ontario CanadaTOPRA North American Leadership Committee Science and Technology Jan 2012 to Sep 2016Consultant Editor Regulatory Rapporteur - TOPRANov 2012 June 2020Canadian Associate of Professionals in Regulatory Affairs (CAPRA) - Publications Officer and News of Course (NOC) EditorFeb 2012 Aug 2014HOBBIESMy Siberian Huskies Mia & Joe, true crime, hiking, road trips, time with family. My interests also include patient advocacy and continued education in my field. |
