Alexandra Acosta
North Brunswick
Summary
Knowledgeable [Desired Position] with solid background in managing clinical trials from inception to completion. Successfully led diverse teams, ensuring compliance with regulatory standards and optimizing trial efficiency. Demonstrated expertise in protocol development and risk management.
Overview
9
9
years of professional experience
Work History
Clinical Trial Leader
Novartis Biomedical Research
04.2022 - Current
- Lead the clinical protocol development process in collaboration with the clinical trial team. Responsible author for clinical protocols, protocol amendments and related documents
- Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, Development Safety Update Report’s, IND/NDA submission documents, and responses to Health Authorities questions
- Develop effective working relationship with investigators to optimize scientific quality and innovation of clinical study design, execution, reporting and publications
- Lead investigator meetings, protocol training meetings and is responsible for all internal clinical meetings related to the clinical trial
- Lead and manage the global clinical trial team to ensure all trial deliverables are met according to timelines, budget, and resource requirements
- Lead the clinical trial data for ongoing medical and scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal and external presentations
- Prepare and lead dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data,to provide consolidated information for dose escalation meetings with investigators
- Forecast trial resources and needs by being accountable for the development, management and tracking of the trial budget
- Oversee the Trial Master File and assures quality of the documentation were in compliance with SOPs, GCP, and ICH guidelines
- Manage central vendors to ensure laboratory supplies and ECG machine distribution occurs according to schedule for all assigned investigate sites
- Collaborate with clinical trial manager and clinical trial team to ensure alignment with supply forecast and study and program requirements for the on-time delivery of clinical supplies
- Mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure global alignment of work practices across the team.
- Manage trials within Oncology which include: Phase Ib CLL and Ib NHL
Associate Clinical Trial Leader
Novartis Biomedical Research
01.2021 - 04.2022
- Supported the clinical protocol development process in collaboration with the clinical trial team
- Contributed to the development of clinical sections of regulatory documents such as Investigators’ Brochures, Development Safety Update Report’s, IND/NDA submission documents, and responses to Health Authorities questions
- Supported the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedure
- Supported the ongoing review and cleaning of the clinical trial data, supported final analysis and interpretation including the development of clinical trial reports, publications and internal and external presentations.
- Supported in preparing dose escalation meetings with investigators. Coordinated the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators
- Responsible for the accuracy of trial information in all trial databases and tracking systems
- Attended relevant meetings to support ongoing execution of clinical trial and program level activities
- Ensured that program specific standards and activities such as CRFs, UAT testing, database specifications, Data Handling plan, outsourcing specifications including imaging, biomarkers, PK, data monitoring, validation plans and data transfer specifications are applied to the clinical trial
- Oversaw the Trial Master File and assures quality of the documentation were in compliance with SOPs, GCP, and ICH guidelines
- Supported trials within Oncology which include: Phase Ib CLL, Phase Ib NHL and Phase Ib Metastatic Breast Cancer
Associate Project Manager
Theradex Oncology
11.2018 - 12.2020
- Responsible for the management and oversight of phase I-III oncology trials from feasibility through close-out/database lock
- Monitored the progress of assigned investigative sites by maintaining close contact with site personnel and site monitors
- Assisted the sponsors and investigative sites with any concern or questions related to project requirements specification that may occur throughout the clinical trial process, and kept the project team informed of all changes to project specifications as they occurred
- Ensured on-time trial start by monitoring the status of or initiating clinical trial supply delivery, provided trial training, prepared and distributed ISF Binders, Questionnaire Booklets, Protocols, Lab Manuals, and Patient Diaries
- Created and devloped study plans such as Commnication Plan, Monitoring Plan, eTMF plan, Protocol Deviation Plan, and Risk Management Plan
- Managed CRAs in successfully monitoring clinical trials by reviewing and approving site reports, conducting weekly meetings, resolving individual and site issues, and maintaining training records
- Coordinated data management activities, ensured timely data entry, data quality and data issue resolution
- Managed clinical trial team meetings and reported trial status to the project team
- Managed and selected central vendors and ensured laboratory supplies, drug supply distribution, and central imaging occured according to schedule for all assigned investigate sites
- Supported Change Orders and Out of Scope work and assisted in communication of budget allocations and approval of invoices
- Oversaw the Trial Master File and Electronic Study Files and assured quality of the documentation were in compliance with SOPs, GCP, and ICH guidelines
- Managed trials within Oncology which included: Phase I AML, Phase I Solid Tumors, Phase II Glioblastoma, and Phase III Atypical Lung Neuroendocrine Tumor
In-House Clinical Research Associate (On Assignment with Sanofi-Aventis)
PRA Health Sciences
07.2017 - 11.2018
- Responsible for the quality and completeness of clinical trial documents by supporting the clinical team in preparation for audits and inspections
- Performed ongoing reviews of eTMF and LSF to assure quality of the documentation files and compliance with SOPs, GCP and ICH guidelines
- Assisted clinical team with the negotiation and execution of the site contract, budget, and payment plan, with final approval from clinical management
- Adhered to a payment schedule for assigned study sites based on site contracts by keeping track and processing site/vendor payments and following up on any issues if required
- Tracked and monitored Institutional Review Board (IRB) annual renewals and Informed Consent Form (ICF) amendments according to site regulations and study requirements
- Tracked the progress of study site activation, enrollment, and monitoring visits
- Managed and contributed to oversight of Third-Party Vendors such as Firecrest, Brookwood, IVRS/IWRS, and Covance
- Ensured all site supplies are available on site for site initiation visits by preparing and distubuting ISF Binders, SIV Binders, Questionare Booklets, Protocols, Lab Manuals, and Patient Diaries
- Supported clinical trials within the U.S. and Global which includes: Phase III Respiratory Diseases (Asthma), Phase II Neurology (Parkinson’s disease), Phase II Rare Diseases (Acid Sphingomyelinase Deficiency) during study start-up, maintenance, and close-out visits
Associate Clinical Data Manager
Novartis Pharmaceuticals Corporation
03.2016 - 07.2017
- Performed activities for start-up of a trial which included Protocol Review, Electronic Case Report Forms, and User Acceptance Testing
- Developed the Data Handling Plan, Data Review Plan, and the Study Specification Documentation for assigned trials
- Wrote specifications for study specific validation checks to ensure high quality and consistent data
- Performed data review throughout the conduct of the study and identified and resolved inconsistencies by initiating the resolution as specified in the Data Handling Plan
- Participated in the activities necessary for database finalization by adhering to the timelines established by the study team
- Tracked and reported the status of assigned tasks and ensured appropriate tracking systems were up to date and accurate
- Performed 3rd Party reconciliation activities according to SOPs and Working Practices
- Supported global trials within Oncology which included: Phase II Lymphoma and Phase III Melanoma
Education
Bachelor of Science - Medical Laboratory Science
Rutgers University
Newark, NJ10.2015
Skills
- Proficient in Oracle Clinical EDC and RAVE EDC
- Proficient in ICH/GCP and related regulations
- Therapeutic areas of expertise include: Oncology, Immuno-Oncology and Hematology
- Skilled in MS Word, PowerPoint, and Excel
- Proficient in English, Spanish, and Portuguese
Timeline
Clinical Trial Leader
Novartis Biomedical Research
04.2022 - Current
Associate Clinical Trial Leader
Novartis Biomedical Research
01.2021 - 04.2022
Associate Project Manager
Theradex Oncology
11.2018 - 12.2020
In-House Clinical Research Associate (On Assignment with Sanofi-Aventis)
PRA Health Sciences
07.2017 - 11.2018
Associate Clinical Data Manager
Novartis Pharmaceuticals Corporation
03.2016 - 07.2017
Bachelor of Science - Medical Laboratory Science
Rutgers University
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