Clinical Data Associate or Clinical Data Management

Marie Finau 650-***-**** / ***********@*****.***

Hercules, CA LinkedIn

Clinical Data Manager

Detail-oriented Clinical Data Management Professional with extensive experience in the pharmaceutical industry. Proven expertise in overseeing clinical trial data management, ensuring compliance with GCP guidelines, regulatory standards, and SOPs. Adept at managing vendor relationships, overseeing budgets, and reconciling financials using platforms such as SAP and iBUY. Strong background in administrative support, including event coordination, database and record management, and executive-level assistance. Adept at streamlining operations, enhancing efficiency, and maintaining meticulous documentation to support clinical trial success. Recognized for exceptional organizational skills, attention to detail, and ability to manage multiple priorities in fast-paced environments.

Technical Skills

DB Management Systems: Bioclinica Express

Software: MS Office Suite (Outlook, Word, Excel, PowerPoint, Project, Access) Visio QuickBooks PRO 2009 Google Application WebEx Skype Adobe Acrobat Pro DC FileMaker PRO SAP (Concur, Fieldglass, iBUY) Smartsheet ORACLE (GUI, JobTracking) iGATE System ETT (inside UPS system) Lotus Notes 7.0 BMC Remedy SharePoint Electronic Data Capture (EDC) Citrix Veeva Vault Trial Interactive Slack IQVIA SCE Spotfire OnePager

Professional Overview

Alector – South San Francisco, CA Aug 2021 – Mar 2025

Senior Clinical Data Associate

Assisted in managing clinical trial databases, including design and review of edit checks and User Acceptance Testing (UAT), to ensure accurate data collection, entry, validation, and compliance with regulatory requirements.

Conducted data quality checks and discrepancy resolution to maintain data integrity throughout the study lifecycle.

Conducted quality control (QC) checks on electronic case report forms (eCRFs) to ensure alignment with study protocols and regulatory guidelines.

Oversaw all Clinical Data Management (CDM) activities, including project timelines, departmental coordination, and meeting documentation.

Conducted QC audits on closed queries, reviewing 1% of resolved cases to verify accuracy and completeness.

Conducted eTMF (Electronic Trial Master File) audits, ensuring all required documents were filed correctly, and collaborated with CRO teams to address discrepancies and missing records.

Managed the quality control of TMF documents in accordance with GCP and regulatory requirements, from study initiation through inspection readiness and archival.

Support the Alector eTMF system administration, implementation, and maintenance (e.g., Veeva Vault eTMF).

Maintained study documentation to ensure compliance and served as the subject matter expert (SME) for regulatory Inspection activities. This includes reporting eTMF quality metrics for studies, as well as creating and editing reports and dashboards to enhance study team awareness.

Performed reconciliation of post-lock biomarker vendor data, ensuring consistency between storage log and vendor datasets by cross-verifying key variables.

Conducted routine Data Quality Review Plan (DQRP) data listings per study-specific cadence, to identify discrepancies, outliers, and documented findings in data issue trackers to ensure timely query resolution and compliance with data standards.

Executed ongoing reconciliation of clinical and safety databases, ensuring consistency and accuracy across multiple platforms.

Managed user access control for Electronic Data Capture (EDC) and Virgil (MedAvante) systems, revoking permissions for individuals no longer affiliated with the company.

Reviewed Spotfire data visualizations for multiple studies to facilitate data cleaning and preparation before database lock.

Generated monthly EDC accounting listing reports to ensure comprehensive tracking and documentation of clinical data activities.

AstraZeneca (Formerly Acerta Pharma) – South San Francisco, CA Jan 2018 – Jul 2021

Clinical Data Associate Mar 2019 – Mar 2025

Oversaw all Clinical Data Management (CDM) activities, ensuring compliance with quality standards, project timelines, and budget constraints.

Managed data review and query resolution to maintain data integrity throughout clinical trial phases.

Provided global oversight and coordination of external vendors supplying clinical data and CDM-related services.

Directed data acquisition, integration, and analysis to support clinical program outcomes.

Ensured adherence to Good Clinical Practice (GCP) guidelines, company SOPs, and regulatory requirements.

Developed, reviewed, and implemented SOPs, templates, and departmental processes to enhance operational efficiency.

Led budget management for the Data Management department, including contract negotiations, vendor invoicing, procurement and financial reconciliation using SAP and iBUY.

Troubleshot and resolved invoice discrepancies between external vendors and Acerta Finance.

Executive/Administrative Assistant Jan 2018 – Feb 2019

Coordinated departmental scheduling, including conducting interviews, scheduling appointments, and prioritizing critical tasks.

Oversaw expense reporting for Data Management staff using Concur.

Maintained and filed Trial Master File (TMF) documentation, ensuring alignment with regulatory standards.

Processed purchase orders (POs), service agreements, and consulting contracts, reconciling payments with suppliers.

Assisted in migrating the Acerta eTMF to the AZ Veeva Clinical Vault eTMF, ensuring compliance with AZ TMF SOPs prior to migration.

CableCom – South San Francisco, CA Mar 2016 – Nov 2017

Senior Administrative Assistant

Provided administrative support to executive management, supervisors, and vendors, ensuring seamless project coordination and management.

Managed clerical tasks including data entry, scheduling meetings, handling correspondence, and preparing presentations and reports.

Answered phones and facilitated communication between internal and external stakeholders.

Maintained office operations by ordering supplies and streamlining administrative processes.

UPS – South San Francisco, CA Nov 2014 – Jan 2015

Helper Coordinator/Customer Service (Contract)

Coordinated daily staffing needs for package delivery helpers, optimizing workforce allocation and utilization.

Developed strong working relationships with package center management and HR representatives to troubleshoot and resolve operational issues.

Provided customer service support by addressing inquiries and ensuring the efficient deployment of helpers.

GamePlan Financial Marketing (Part-Time) – Woodstock, GA & Phoenix, AZ Feb 2013 – Oct 2019

Broker/Insurance Agent (License #0H20296)

Sold various life and accidental death insurance policies to individuals, assessing client needs and recommending tailored coverage solutions.

Scheduled and conducted client appointments to review existing policies, identify gaps, and suggest appropriate coverage options.

Maintained a database of prospective clients, ensuring timely follow-ups and fostering long-term relationships.

Provided exceptional customer service, guiding clients through the insurance process and addressing inquiries to enhance customer satisfaction.

Education & Credentials

HS Diploma – API FOOU College (Formerly St. Mary’s High School)

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