Highly talented and accomplished Project Management Associate with extensive experience in Clinical Trials & Site Management at a Fortune 500 pharmaceutical company. Significant exposure in managing Phase I-III Oncology trials (Non-Hodgkin’s Lymphoma, Leukemia, Colorectal Cancer & Metastatic Breast Cancer) throughout Study Start-up, Conduct and Close down, including resource and financial management. Possess a strong background in all
Highly talented and accomplished Project Management Associate with extensive experience in Clinical Trials & Site Management at a Fortune 500 pharmaceutical company. Significant exposure in managing Phase I-III Oncology trials (Non-Hodgkin’s Lymphoma, Leukemia, Colorectal Cancer & Metastatic Breast Cancer) throughout Study Start-up, Conduct and Close down, including resource and financial management. Possess a strong background in all aspects of operations, with expertise in Trial Master File, problem resolution and project management. Frequently recognized for ability to build strong, positive relationships with all stakeholders, internal and external. Consistently successful in meeting timelines and producing high quality work.
Therapeutic Area Expertise: Oncology; Non-Hodgkin's Lymphoma, Leukemia, Colorectal Cancer, Metastatic Breast Cancer
Clinical Research Study Manager @ From September 2015 to Present (4 months) Senior Clinical Trial Specialist @ From June 2014 to Present (1 year 7 months) Associate Project Manager, Study Start Up @ Tracked project progress against financial milestones as agreed upon with the client. Designed, implemented, tracked and revised project plans. Managed and tracked project resource needs and contigency planning for key resources. Created, modified and implemented billing guides as necessary based on project deliverables. Directed and managed team members to ensure timeliness were met and clinical trial sites were activated to begin enrollment. Developed country level cite study budgets and oversaw and approved all budget negotiations on behalf of the client. Led weekly teleconferences with team members to ensure awareness of impending timelines, recieved updates on outstanding regulatory approvals and mitigated and planned for any potential issues that may have delayed site activation. From October 2012 to May 2014 (1 year 8 months) Country Senior Study Analyst @ Was responsible for coordination and support of one or more Local Study Teams to ensure the standardization and consistency of clinical development processes across studies in accordance with ICH-GCP guidelines, local regulations, Roche SOPs, applicable local operating guidelines and current best practices. From August 2008 to October 2012 (4 years 3 months) Clinical Operations Coordinator @ Completed tasks assigned by Local Study Teams that enabled the team to meet project goals and deliverables for all phases of the clinical trial process. Tasks included creating regulatory and general communication documents, coordinating internal local study team processes to meet safety and regulatory requirements as outlined in Roche SOPs and co-monitoring to support site management activities. From November 2006 to August 2008 (1 year 10 months) Clinical Sample Coordinator @ Liaised with Pharma Development Operations for the organization of their PK/PD and genomics sampling for Phase II through IV clinical trials. Identified client needs and proposed sample kits for the various trials, while ensuring consistency throughout all Roche studies. In addition, played an integral role in the tracking of all biological specimens through inspection and reporting of non-compliance. Managed clinical trial supplies, prepared and dispatched study material to clinical sites. Assisted sites in any issues that arose in regards to clinical trial samples. Liaised with vendors to ensure timely delivery of samples and performed troubleshooting with various project teams in relation to vendor processes. Served as back-up to the Local Site Head. From 2004 to 2006 (2 years)
BA, Business @ Fairleigh Dickinson University Shannon Ibabekci is skilled in: Project Management, Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Trial Managment, Oncology, ICH-GCP, EDC, Sop, Clinical Development, Clinical Operations, GCP, CTMS, Clinical Monitoring, CRO, Therapeutic Areas, Drug Development, Clinical Data Management
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