Clinical Data Management, Clinical Research, Data Quality & Review, Project Leadership, Global Operations, Safety, EDC
Orange County, California Area
ER Clinical Solutions. Inc.
Independent Consultant, Clinical Research and Data Management Professional
January 2015 to Present
Sr. Manager, Clinical Data Management
June 2009 to November 2014
Project Manager/e-Solutions Coach - R&D Information Systems
August 2007 to June 2009
Principal Clinical Research Associate - Global Development Operations, Ophthalmology TA
April 2005 to July 2007
Principal Clinical Data Analyst
June 2002 to March 2005
Chimeric Therapies, Inc
Clinical Data Manager/DBA
August 2000 to May 2002
Sr. Clinical Data Coordinator
1999 to August 2000
Clinical Data Reviewer
1998 to 1999
Clinical Research Coordinator, Biotech Division Immunotherapy/Gene Therapy
1996 to 1998
Baxter Healthcare - Edwards Laboratories
Sr. Research Scientist
1982 to 1995
Clinical Research consultation includes the following services, which may include, but not limited to the following: a) Data Management, Study Management, Clinical Trial Systems/Development (EDC, IxRS, ePRO, eCOA), Implementation and Integration b) Project Management, Oversight, Change In Scope Management c) Vendor Management; Bid Defense, CRO, FSP and Third Party d) Budget Management, Forecasting, Planning e) Standardization, Process... Clinical Research consultation includes the following services, which may include, but not limited to the following: a) Data Management, Study Management, Clinical Trial Systems/Development (EDC, IxRS, ePRO, eCOA), Implementation and Integration b) Project Management, Oversight, Change In Scope Management c) Vendor Management; Bid Defense, CRO, FSP and Third Party d) Budget Management, Forecasting, Planning e) Standardization, Process Improvement and Efficiencies f) Quality Review, Documentation, Specifications, Requirements g) Vendor Selection and Qualification h) Training and Development I) GxP Compliance, Local and International Regulations j) Global Clinical Trials Oversight
What company does Eloisa Rodriguez work for?
Eloisa Rodriguez works for ER Clinical Solutions. Inc.
What is Eloisa Rodriguez's role at ER Clinical Solutions. Inc.?
Eloisa Rodriguez is Independent Consultant, Clinical Research and Data Management Professional
What industry does Eloisa Rodriguez work in?
Eloisa Rodriguez works in the Pharmaceuticals industry.
I am someone with over 20 years of experience in pharmaceutical, biotechnology and CRO environment.I am a Clinical Data Management professional specializing in Project Management, Data Operations, Team Leadership, Budget and Vendor Relations. I have contributed to successful drug approvals in foreign and domestic markets. What I can do for you is to bring my data management expertise, leadership skills with internal or virtual teams and hands on approach in clinical trials ensuring data quality with focused on patient's safety all within budget and timely delivery.Independent Consultant, Clinical Research and Data Management Professional @ Clinical Research consultation includes the following services, which may include, but not limited to the following: a) Data Management, Study Management, Clinical Trial Systems/Development (EDC, IxRS, ePRO, eCOA), Implementation and Integration b) Project Management, Oversight, Change In Scope Management c) Vendor Management; Bid Defense, CRO, FSP and Third Party d) Budget Management, Forecasting, Planning e) Standardization, Process Improvement and Efficiencies f) Quality Review, Documentation, Specifications, Requirements g) Vendor Selection and Qualification h) Training and Development I) GxP Compliance, Local and International Regulations j) Global Clinical Trials Oversight From January 2015 to Present (1 year) Sr. Manager, Clinical Data Management @ Overall responsible for the execution of Data Operations, Technology setup, including data integration, data processing to support study start up to database lock across multiple studies. Provided project leadership, management and coordination of data operation activities across functional teams globally. Served as a the primary point of contact for project status, metrics, deliverables and project timelines. Served as a Data Management Team Lead (DMTL) supporting lead data managers. Functioned as Lead Data Manager (LDM) when no Data Manager is available to manage other studies to database lock. Reviewed data management plan, specifications, project plans and report outputs. Managed the quality control process for eCRFs and edit checks to ensure standards are utilized. Reviewed and provided input to protocol design, safety data review, medical coding and protocol deviations identification. Served as a Subject Matter Expert (SME) in creating EDC/IxRS training materials for project teams, CRA and sites. Provided study specific training for all clinical trial systems. Performed budget forecast for Clinical projects. Reviewed and approved changes in scope to ensure operating costs are within budget and if outsourced, within contractual agreement. Supported regulatory submissions for International studies including PMDA and CFDA. General areas of responsibility include: 1. Vendor Management activities such as selection and qualification of outsourced partners (CRO, FSP). Review of RFPs, assisted in writing contractual agreements, scope of work and invoice payments. 2. Functioned in line management role with direct reports supporting data management operations including CRO and FSPs. Managed, supported and provided mentoring in development/training of clinical data management personnel. In addition to Performance Evaluation. From June 2009 to November 2014 (5 years 6 months) Project Manager/e-Solutions Coach - R&D Information Systems @ Provided expertise in the study design and setup of EDC, IVRS and ePRO applied to system functionality and systems environment. Advised and mentored study teams on their roles and responsibilities applied to eSolutions process. Faciliated the adoption of the EDC and IVRS for in-house use, participated in the validation of the CORE system platforms for IVR/IWRS and hand-held devices contributing to the development of the IVR lifecycle development standards. Evaluated current systems process for future enhancement and improvement in collaboration with vendors. Provided input in vendor selection provess, contract and service level agreements. From August 2007 to June 2009 (1 year 11 months) Principal Clinical Research Associate - Global Development Operations, Ophthalmology TA @ Global site management for Ph III clinical trials, e.g. site recruitment, site training, site payments, Regulatory Document management and tracking usign CTMS IMPACT. Supported the Asia Pacific region in study startup of international site and tracking of regulatory requirements and EC submissions. Monitoring and co-monitoring activities, clinical trial supply management, vendor management and assessment of Reading centers and IVRS. Reviewed global monitoring plans. Served as the liaison with Data Management pertaining to clinical data issues. Trained clinical team in the conduct of manual data review, From April 2005 to July 2007 (2 years 4 months) Principal Clinical Data Analyst @ Coordinated internal resources and activities within BDMP, Clinical and Research Compliance to facilitate timely collaboration for multiple clinical projects. Lead and influenced multi-disciplinary Clinical Trial teams to effectively manage information flow, data collection, review and clarification activities in compliance to company regulations and departmental guidelines. Responsible for supporting the design, documentation, testing, implementation, validation, and utilization of systems and processed within the Clinical Data Management area applied to EDC and ePRO systems. Managed Contract Research Organization (CROs) and service providers’ activities for outsourced Clinical Trial services Served as a member of the steering committee in the implementation of global standards related From June 2002 to March 2005 (2 years 10 months) Clinical Data Manager/DBA @ Managed, hired, trained and supervised Clinical Data Associates and Data Entry personnel. Good working knowledge of DataFax, Oracle Clinical, Clintrial and the ability to work with data in a variety of formats including SAS, ASCII, and Excel. Designed CRF using FrameMaker software Established working relationships with CRO and management of deliverables. Managed project budget and reviewed expenses against progress of the trial. Assisted in the review of source documents for patient enrollment and randomization for the Leukemia trials. From August 2000 to May 2002 (1 year 10 months) Sr. Clinical Data Coordinator @ Developed data management documents such as: Data Entry guidelines, Data Handling procedures and Clinical Data Review guidelines. Participated in project specific database design from development to production. Generated queries from clinical data review, data listing review, electronic edits and customized reports. Coding experience with MedDRA, COSTART and WHO Drug. Provided training and orientation to new personnel joining the team. Attended team and clinical project meetings. From 1999 to August 2000 (1 year) Clinical Data Reviewer @ Performed clinical data review of pre-monitored and monitored CRF data using scanning and imaging technology.Processed validation checks, generated DCFs. Reviewed and resolved data issues of outstanding CRFs and queries with the sites. Data entry of SAEs using ARISLITE and Adverse Reaction Information System software. QC review of SAE narratives identifying data inconsistencies. Assisted with the system validation of Oracle Clinical database. Maintenance of documentation for clinical data management activities, development, initiation of study review manuals, review and modification of SOPs. From 1998 to 1999 (1 year) Clinical Research Coordinator, Biotech Division Immunotherapy/Gene Therapy @ Clinical research emphasis on: Oncology, Hematology, Immunology and Gene Therapy. Generated queries from inconsistent CRF data and update query resolutions in ACCESS Query Tracking database. Provided status reports of outstanding queries to the monitors prior to the site visits. Maintained regulatory/clinical documents (e.g. informed consent forms, Form FDA 1572, IRB documentation, investigator’s brochures, protocols, etc.). Assisted in maintenance of databases for Phase I/II studies in BBN/Clintrial. Interfaced with clinical monitors and other project team members to facilitate collection, review of CRFs to ensure accurate and consistent data. Participated in a mock FDA audit. From 1996 to 1998 (2 years) Sr. Research Scientist @ Laborotory research and data analysis focused on Immunology, Oncology and Gene Therapy. Performed experiments using immunology staining procedures, gene cloning techniques, tumor markers & selection, T-cell expansion and cell-separation under GLP requirements. From 1982 to 1995 (13 years) Cell/Cellular and Molecular Biology @ California State University-Long BeachBachelor of Science (B.S.), Biochemistry @ University of Santo Tomas Eloisa Rodriguez is skilled in: CRO, Clinical Trials, Data Management, GCP, CTMS, Clinical Development, Pharmaceutical Industry, EDC, Clinical Data Management, FDA, Oracle Clinical, SOP, CRF design, Biotechnology, Vendor Management
Introversion (I), Intuition (N), Thinking (T), Judging (J)
3 year(s), 2 month(s)
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