Summary
Overview
Work History
Education
Skills
Accomplishments
Therapeutic Area Experience
Audit Experience
Computer Experience
Timeline
Generic

Tara Azevedo

Austin,TX

Summary

Accomplished Director and visionary leader with a proven track record in strong relationships and successful study implementation, driving self and teams to think creatively and with innovation for long term success. Expert problem-solving capability and in-depth understanding of team collaboration to promote effective and efficient study milestone accomplishments. Experience across all phases and multiple therapeutic areas, complexity levels, study programs, sizes, and across various database platforms, with special focus upon idiosyncrasies of the challenges in collection of local lab data.

Overview

18
18
years of professional experience

Work History

Director, Clinical Data Management

Alector
South San Francisco (Remote), CA
01.2022 - Current
  • Documented processes and drafted SOPs to comply with regulations and company policies.
  • Created outline of process and timelines for Standard eCRFs project
  • Oversight of operations and provided corrective feedback to achieve daily and long-term goals.
  • Monitored and coordinated workflows to optimize resources.
  • Expert oversight of 3 key programs, all corporate goals for 2022
  • Vendor selection for two studies on critical path due to key corporate goals
  • Key participant in CDM goal of preferred partnership clinical service providers
  • Line management of team of FTEs and Consultants/Contractors

DIRECTOR

PPD
Austin, USA
04.2020 - 12.2021
  • Oversight of Data Management processes, ensuring timelines and contacts are adhered to and quality standards are met.
  • Instrumental in bringing in new data management business through bidding activities, attending bid defense meetings and developing dynamic data management strategies.
  • Manages staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
  • Ensures that DM tasks are clearly understood and completed in line with protocol, contract, GCP and SOPs/WPDs.
  • Support of SOP/WPD creation and revisions.
  • Manages workload allocation and establishing priorities of assigned project teams, ensuring quality, efficiency and within given timeline and while meeting utilization targets.
  • Performs senior level customer communication / collaboration.
  • Develops, implements and tracks appropriate departmental performance metrics.
  • Supports HR activities and takes ownership for supporting management activities for allocated team.
  • Participates in formation and implementation of strategic development plans for data management with ability to identify improvement opportunities, devise strategy and implement necessary tactical activities to achieve strategy.
  • Ensures adherence to Company and Department policies and procedures and effectively manages quality and training compliance.
  • Oversight of PPD's Specialty Local Lab Team, inclusive of team and process development, hiring and training program.

ASSOCIATE DIRECTOR

PPD
Austin, TX
04.2018 - 03.2020
  • Provided supervisory function for senior staff within assigned team ensuring that DM tasks are clearly understood and completed in line with protocol, contract, GCP and SOPs/WPDs.
  • Performed ongoing performance appraisals and supports staff development for direct reports.
  • Supports HR activities and takes ownership for supporting management activities for allocated team.
  • Managed workload allocation and establishing priorities for assigned project teams; produce status reports for management and clients as required; and ensure quality, efficiency and timeliness of work for assigned staff.
  • Performed senior level customer communication/coordination.
  • Developed and presented proposals in response to requests from potential customers and supports business development activities presenting data management strategy at bid defense meetings.
  • Developed, implemented, and tracked appropriate departmental performance metrics.
  • Managed resources and workload of direct reports with focus on achieving or exceeding utilization targets.
  • Participated in formation and implementation of strategic development plans for data management.
  • Promoted repeat business relationships with existing clients and is instrumental in bringing new data management business to PPD through business development activities.
  • Oversight of PPD's Specialty Local Lab Team, inclusive of team and process development, hiring and training program.

GROUP MANAGER

PPD
Austin, TX
10.2014 - 03.2018
  • Created PPD's Specialty Local Lab Team, inclusive of team and process development.
  • Developed Client-specific handbooks to support operational work within Data Management, Programming, Biostatistics and Medical Writing.
  • Managed day-to-day operations for a group of CDM projects or key functions as well as manage project staff and workloads for direct reports.
  • Responsible for customer contact, functional, administrative and financial oversight of projects assigned.
  • Provided supervisory functions for individual contributing staff within CDM department including training and mentoring of staff.
  • Participated in business development activities as required.
  • Performed Project Management role for studies that do not have clinical component or act as Franchise Manager for allocated clients.
  • Assisted CDM senior management with formation and implementation of strategic development plans for department.
  • Participated in development and implementation of processes, procedures and training for data management function.

MANAGER

PPD
Austin, TX
04.2013 - 10.2014
  • Management of Clinical trails, responsible for all study level resourcing, forecasting and actualization of budgets. Ensured timelines were met with quality and within budget.
  • Provided supervisory function for team of allocated staff within Clinical Data Management department including training and mentoring.
  • Supported HR and Clinical Data Management senior management with hiring and development of Clinical Data Management personnel.
  • Allocated clear responsibilities within Clinical Data Management team for each assigned project to enable all targets to be met.
  • Ensured that all data management activities are conducted in line with regulatory guidelines, global Standard Operating Procedures (SOPs), and client expectations.
  • Participated in development and implementation of processes, procedures and training for Clinical Data Management function.

PRINCIPAL CLINICAL DATA MANAGER

PPD
Austin, TX
12.2010 - 03.2013
  • Acted as lead data manager and/or study manager for projects, dependent upon study need.
  • Independently led and managed multiple, high volume and extremely complex studies within development program.
  • Responsible for all study level resourcing, forecasting and actualization of budgets.
  • Creation and/or Review of eCRF, Data Management Plans, eCRF Guidelines, and Edit Check Specifications.
  • UAT of eCRF and Edit Checks, if necessary within role being performed.
  • Independently and efficiently performed, with quality, all data management activities within assigned study.
  • Mentored junior level staff and peers on all associated tasks within study or program.
  • Responsible for customer contact, functional, administrative and financial oversight of projects assigned.
  • Participated in development and implementation of processes, procedures and training for data management function.
  • Participated in business development activities as required.
  • Assigned, review and check work of others performing similar duties.

CLINICAL DATA MANAGER II

PPD
Austin, TX
05.2008 - 12.2010
  • Acted as lead data manager for multiple, high volume/highly complex studies.
  • Independently led, with quality, all data management activities within assigned studies end to end.
  • Creation of eCRF, Data Management Plans, eCRF Guidelines, and Edit Check Specifications.
  • UAT of eCRF and Edit Checks.
  • Mentored junior level staff on all associated tasks within studies.
  • Liaised with sponsors as required and communicate with management regarding all data management activities within studies.
  • Participated in business development activities as required.
  • Designated tasks appropriately within team ensuring all work conducted is completed to acceptable quality in accordance with global Standard Operating Procedure (SOPs) and Data Management Plan.
  • Represented Clinical Data Management at internal and external meetings and presentations.

CLINICAL DATA MANAGER I

PPD
Austin, TX
04.2007 - 05.2008
  • Acted as lead data manager for multiple projects within program of studies.
  • Led all data management activities for individual, limited volume/complexity studies with mentoring from CDM II or Manager, CDM.
  • Independently and efficiently perform, with quality, all data management activities within assigned studies.
  • Creation of eCRF, Data Management Plans, eCRF Guidelines, and Edit Check Specifications.
  • UAT of eCRF and Edit Checks.
  • Mentored associate level staff on all associated tasks within studies.
  • Liaised with sponsor and communicated with management regarding all data management activities within studies.
  • Designated tasks appropriately within team ensuring all work conducted is completed to acceptable quality in accordance with global Standard Operating Procedure (SOPs) and Data Management Plan.
  • Represented Clinical Data Management at internal and external meetings and presentations.

CLINICAL DATA ASSOCIATE III

PPD
Austin, TX
06.2006 - 04.2007
  • Performed all aspects of data cleaning process in accordance with GCPs and SOPs/WPDs.
  • Key responsibilities were data listing reviews, reconciliation of Serious Adverse Events and third-party vendor data.
  • Supported Lead Data Manager by performing activities such as CRF design, database design and Data Validation Manual creation.
  • Performed initial review of data discrepancies and database updates.

CLINICAL DATA ASSOCIATE II

PPD
Austin, TX
12.2005 - 06.2006
  • Performed advanced aspects of data cleaning process with high degree of accuracy and in accordance with GCPs and SOPs/WPDs.
  • Key responsibilities were to perform initial review of data discrepancies and database updates, data listing reviews, reconciliation of Serious Adverse Events and third-party vendor data.

CLINICAL DATA ASSOCIATE I

PPD
Austin, TX
03.2005 - 12.2005
  • Performed entry level aspects of data cleaning process, with high degree of accuracy and in accordance with GCPs and SOPs/WPDs.
  • Key responsibilities were to perform initial review of data discrepancies and database updates.

CLINICAL STUDY RECRUITER

PPD
Austin, TX
03.2004 - 03.2005
  • Responsible for successful conduct of multiple ongoing clinical trials involving patients or healthy volunteers.
  • Prepared required paperwork (i.e. Source documents, clinical labels, physical forms) and any other form required by study protocol.
  • Supported Clinical trial assessments necessary as per protocol Schedule of Events.

Education

Bachelor of Arts - Psychology

Texas State University
San Marcos, TX
2002

Skills

  • Effective leader
  • Solution oriented
  • Forward thinking
  • Client relations
  • Risk Mitigation
  • Issues resolution / Negotiation
  • Financial Management
  • Strategic planning and execution
  • Team building / Specialty Team creation
  • Business Development
  • Excellent oral and written communication
  • Strong mentor and collaborative team member
  • Excellent organization, prioritization and time management

Accomplishments

  • CEO Performance Excellence Award, 2015, for creation of a Client Specific Biometrics Handbook which helped secure a partnership.
  • CEO Performance Excellence Award, 2017, for strong Client relationships and successful study executions.

Therapeutic Area Experience

  • Cardiovascular
  • Critical Care
  • Endocrine / Metabolic
  • Gastrointestinal
  • Immunology
  • Hematology / Oncology
  • Neurology
  • Musculoskeletal
  • Pain
  • Respiratory

Audit Experience

  • Internal Process Audit
  • Trial Master File (TMF) Audit
  • Regulatory Authority Audit (FDA, MHRA)
  • Client Audits

Computer Experience

  • MS Office Suite, Adobe Professional, Synergy
  • eTMF (Veeva Vault)
  • EDC (Oracle Clinical (Classic), OC-RDC, Oracle Inform, Medidata Rave, OmniComm TrialMaster
  • SAS Viewer
  • Clarity FORUM

Timeline

Director, Clinical Data Management

Alector
01.2022 - Current

DIRECTOR

PPD
04.2020 - 12.2021

ASSOCIATE DIRECTOR

PPD
04.2018 - 03.2020

GROUP MANAGER

PPD
10.2014 - 03.2018

MANAGER

PPD
04.2013 - 10.2014

PRINCIPAL CLINICAL DATA MANAGER

PPD
12.2010 - 03.2013

CLINICAL DATA MANAGER II

PPD
05.2008 - 12.2010

CLINICAL DATA MANAGER I

PPD
04.2007 - 05.2008

CLINICAL DATA ASSOCIATE III

PPD
06.2006 - 04.2007

CLINICAL DATA ASSOCIATE II

PPD
12.2005 - 06.2006

CLINICAL DATA ASSOCIATE I

PPD
03.2005 - 12.2005

CLINICAL STUDY RECRUITER

PPD
03.2004 - 03.2005

Bachelor of Arts - Psychology

Texas State University

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Tara Azevedo