Maritza Ceja Email & Phone Number

Thousand Oaks, Ca, Us

Dublin, Ireland, Ie

Rare Disease

North Chicago, Illinois, Us

· Manage Virology HIV Phase IIb & HCV Phase I, II and III global studies· Experience in study initiation through study completion (including site feasibility, site selection, site audits, and CSR)· Proactively identify, resolve and/or escalate study related issues and opportunities for efficiency· Preparation and dissemination of Clinical Study team meeting agenda and meeting minutes· Support development of clinical study blueprint, protocol, informed consents, eCRFs, IRT, CSR· Collaborate with Quality Assurance and clinical site monitoring to address site audit findings· Responsible for regular updates to the cross-functional team and stakeholders on study status· Responsible for oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations· Manage and review TESLA Observations to ensure documentation is clear and accurate· Manage CRO run studies· Plan and execute Kick-Off meetings and Investigator Meetings for global studies· Create, disseminate, and provide study specific protocol training for the study team and study sites· Mentor to other Study Management Associates· Participate in process improvement initiatives

Morrisville, Nc, Us

· Supported Virology HCV Phase I, II and III studies· Main point of contact for external vendors and other internal functional areas; Data Management, Statistics, Monitors, and other cross-functional team members· Performed start-up activities including forming study team, setting up vendor systems, preparing and presenting at kick off meetings· Executed one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)· Collaborated with Study Project Manager in leading the cross functional study team· Supported the preparation of Clinical Study Team meetings (Agenda/Minutes)· Responsible for regular updates to the cross-functional team and stakeholders on study status; ensured CTMS is up to date· Supported the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)· Supported the vendor selection, scope development, management, and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations· Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies· Reviewed and approved study invoices according to executed budgets

Raleigh, North Carolina, Us

• Supported Oncology Non-Small Cell Lung Cancer Phase II study• Supported Substance Abuse Disorder study, as well as sister-study for Severe Opioid Addiction, Phase III with schedule 3 drug, FDA Approved Sublocade.• Successfully supported PRA FDA Inspection• Successfully supported Sponsor FDA Inspection• Co-Managed audit readiness efforts for multiple studies across one project• Managed and delegated tasks to large team during audit readiness efforts• Managed a heavy workload, and multiple projects with competing priorities and deadlines• Maintained constant communication with 3rd party auditors within sponsor's SharePoint in an effort to review, resolve and escalate issued findings• Exported external vendor data for query resolution. Proactively identified query issues within reasonable timelines aligned with project specific milestones and escalated accordingly• Resolved self-evident queries in Electronic Data Capture (EDC)• Liaison between project team members regarding study site issues• Supported investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements• Attended on-site monitoring visits to support monitoring activities as needed• Performed essential document collection, review, maintenance & close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines• Performed study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study• Tracked and facilitated the regulatory document review process. Reviewed site informed consents, Form FDA 1572, site delegation logs and other documents to ensure compliance with regulatory requirements.• ICF Translation QC Reviewer

• Responsible for maintaining an inventory of over 1,200 SKUs. Entering orders and creating new items in a proprietary inventory system. Maintaining data integrity by analyzing and resolving discrepancies.• Coordinating logistics for approximately 10 trade shows per year in the Chicagoland area and 2 shows per year in Las Vegas. • Conducting merchandise and sales research. Researching potential merchandise to analyze the market value and determine best candidates. • Managing administrative affairs and updating internal processes. Documenting procedures and determining best internal practices based on the needs of the business.• Accounts Payable and Accounts Receivable• Addressing logistical issues: Obtaining freight quotes, filling out customs and NAFTA forms when necessary for overseas customers.• Fielding any issues with purchase orders or invoices as needed by coworkers or buyers.

• Direct assistant to the Chief Medical Officer. Attended weekly meetings with the CMO to follow each initial Utilization Review all the way through to the appeal process if necessary.• Evaluated IMEs and URs, advised providers, account managers, and attorneys as to how to proceed with medical procedures, billing, and litigation. • Assisted in preparing depositions by researching the specifics of patients’ medical records and documenting the chronological order of UR, IME and any possible violations that occurred within the UR based on URAC Guidelines or IME violations based on Workers Compensation Laws.• Researched medical records to ensure providers responded to IME reports and/or Utilization Review determinations. • Served as the liaison for five clinics, providing training and support to employees at each clinic. • Maintained data integrity across three separate entities by analyzing and resolving system discrepancies.

Buffalo Grove, Illinois, Us

• Responsible for integration of new customers into the proprietary system. Provided ongoing data integrity reviews and managed mapping of various data relationships to assist customers in business decisions. • Provided outstanding customer support by serving as liaison between internal and external customers. • Facilitated communication for customer requests and procedure changes for several multi-million dollar accounts.• Developed and documented training material and trained all new incoming personnel.