Summary
Overview
Work History
Education
Skills
Formal Educational History
Clinical Trial Experience
Therapeutic Experience
Publications Doctoral Thesis
Business Title
Certification
Timeline
Generic

Sacnite Albarran

Data Team Lead (DTL)
Morelia,Michoacan

Summary

8 years in clinical research filling positions as a Clinical Data Associate, Sr. Clinical Data Associate, Lead Clinical Data Manager where my responsibilities covered; however were not limited to: Operational experience in Data Management (DM) that has spanned the full duration of studies, from study start-up to database lock on various global/multi-national studies (Phase I, II, III) across USA, South America, United Kingdom, Europe, Asia, India, Japan and Australia with significant experience working on Chronic Lymphocytic Leukemia, Influenza A (H1N1), Diabetic Macular Edema, Solid Tumor Configuration, Alzheimer's Disease, Postherpetic Neuralgia studies. On 30 October 2020 I took on the responsibilities of a Data Team Lead (DTL). The responsibilities of a DTL include but are not limited to: independently manage end-to-end delivery of data management services for projects, ensuring quality deliverables on time and within budget; providing comprehensive data management expertise to the Clinical Data Management (CDM) team; provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables to ensure high quality data management products that meet the customer needs.

Overview

16
16
years of professional experience
1
1
Certification
2
2
Languages

Work History

Lead Clinical Data Manager

IQVIA and its Affiliated Companies
10.2020 - Current
  • Lead negotiations with customers, participates in pricing discussions and supports the Request for Proposal (RFP) process
  • Manage Scope of Work (SOW) and/or budget, ensuring that services are met according to the SOW/contract
  • Serve as point of contact for customers on data management deliverables, ensuring open communications with the customer and IQVIA management to meet contractual obligations
  • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
  • Meet with Data Operations team members to ensure milestones meet timelines and quality deliverables
  • Manage process improvements and workload projections
  • Manage DM service delivery with comprehensive DM process and technical expertise
  • Create and/or review and sign-off on all data management plan (DMP) documents
  • Ensures service and quality meet agreed upon specifications per the DMP and contract/SOW
  • Ensure appropriate resources are assigned to meet project deliverables
  • Implement quality management plans
  • Provide training and development and data management expertise to DM team members
  • Train, mentor and provide leadership to the DTL team
  • Ensure project milestones are met according to agreed upon timelines
  • Serve as the escalation point for unresolved data issues working with client data managers, vendors, internal team members for resolution
  • Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
  • Ensure timely follow-up and resolution of issues
  • Escalate problems/issues to the attention of the Project Manager and Line Manager.

Senior Clinical Data Associate

Syneos Health
11.2019 - 10.2020
  • Performs tasks in compliance with Standard Operating Procedures (SOPs)/Work Instructions (WIs), regulatory directives, and study specific plans and guidelines
  • Performs advanced Case Report Form (CRF) /electronic Case Report Form (eCRF) data review including query creation, closure and re-queries as necessary and listing review with increased independence and efficiency
  • Performs essential functions which supports database testing including user acceptance testing (UAT) and SAS mapping, quality control (QC) as well as additional Data Management (DM) activities such as Serious Adverse Event (SAE) and external data reconciliations, create/update eCCGs (Electronic CRF Completion Guidelines) and Communicate with Project Manager (full services studies) or Biometrics Project Manager (single service studies).

University Teacher

Biology Faculty in Iztacala UNAM
02.2015 - 08.2020
  • Teacher of Comparative Animal Morphophysiology lectures

Clinical Data Associate III

Syneos Health (Formerly INC Research)
11.2018 - 10.2019
  • Performs tasks in compliance with Standard Operating Procedures (SOPs)/Work Instructions (WIs), regulatory directives, and study specific plans and guidelines
  • Performs advanced Case Report Form (CRF) /electronic Case Report Form (eCRF) data review including query creation, closure and re-queries as necessary and listing review with increased independence and efficiency
  • Performs essential functions which supports database testing including user acceptance testing (UAT) and SAS mapping, quality control (QC) as well as additional Data Management (DM) activities such as Serious Adverse Event (SAE) and external data reconciliations, create/update eCCGs (Electronic CRF Completion Guidelines) and Communicate with Project Manager (full services studies) or Biometrics Project Manager (single service studies).

Clinical Data Associate II

Syneos Health (Formerly INC Research)
05.2017 - 11.2018
  • Performs tasks in compliance with Standard Operating Procedures (SOPs)/Work Instructions (WIs), regulatory directives, and study specific plans and guidelines
  • Performs advanced Case Report Form (CRF) /electronic Case Report Form (eCRF) data review including query creation, closure and re-queries as necessary and listing review with increased independence and efficiency
  • Performs essential functions which supports database testing including user acceptance testing (UAT) and SAS mapping, quality control (QC) as well as additional Data Management (DM) activities such as Serious Adverse Event (SAE) and external data reconciliations.

Clinical Data Associate I

INC Research, LLC
11.2015 - 05.2017
  • Performs Case Report Form /electronic Case Report Form (CRF/eCRF) data review in compliance with Standard Operating Procedures/Work Instructions (SOPs/WIs), regulatory directives, and study specific plans, and guidelines.

University Teacher

School of Chemistry and Pharmacology at UMSNH
02.2008 - 08.2010
  • Teacher of Biochemistry and Celular Biology lectures

Education

Ph.D. - Neurosciences-Parkinson's Disease

CINVESTAV, Mexico
Mexico City
05.2001 -

Master of Science - Experimental Biology

Chemistry And Biological Research Institute, UMSNH
Morelia
05.2001 -

Bachelor of Science -

School of Chemistry And Pharmacology, UMSNH
Morelia
05.2001 -

Skills

    - Problem Solver - Organized - Attention to details - Good Listener - Works under pressure - Teamwork - Emphatic - Quick Learner

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Formal Educational History

  • 11/2010, CINVESTAV, Mexico, Doctor of Philosophy, Neurosciences-Parkinson's disease, Attended - not Completed
  • 11/2007, Chemistry and Biological Research Institute, UMSNH - Mexico, Mexico, Master of Science, Experimental Biology, Completed
  • 06/2006, School of Chemistry and Pharmacology, UMSNH - Mexico, Mexico, Bachelor of Pharmacy, Pharmacology, Completed

Clinical Trial Experience

  • Phase 2, Hypertriglyceridemia, Other, 5, 35, 320, Lead Data Manager, Database Build, DM activities during start up. EDC updates per Protocol Amendments (CRFs updates).
  • Phase 2, Dyslipidemia, Other, 5, 25, 180, Lead Data Manager, Database build, DM activities during start up. EDC updates for Protocol Amendments (CRFs updates).
  • Phase 3, Myelofibrosis, Small Molecule (Kinase Inhibitor), 16, 136, 310, Lead Data Manager, All DM functional lead activities, from database build, UT, DM metrics, development and maintenance of DM Project Documentation, Data Review listings specifications, coordinate with the EDC programmer for Protocol Amendment updates in EDC. Query management, Data Reconciliations.
  • Phase 3, Fabry's Disease, Rare Diseases, Biosimilars, 1, 5, 30, Lead Data Manager, DM functional lead activities, from database build, UT, DM metrics, development and maintenance of DM Project Documentation, Data Review listings specifications, coordinate with the EDC programmer for Protocol Amendment updates in EDC. Query management, Data Reconciliations.
  • Phase 1, Solid Tumor Configuration, Chemotherapy, 3, 30, 300, Lead Data Manager, DM functional lead activities, from database build, UT, DM metrics, development and maintenance of DM Project Documentation, Data Review listings specifications, coordinate with the EDC programmer for Protocol Amendment updates in EDC. Query management, Data Reconciliations.
  • Phase 3, Malignant Tumor of Ovary, Critical / Trauma Care, Chemotherapy, 7, 250, 418, Clinical Data Manager, All DM functional lead activities, from database updates, UT, DM metrics, development and maintenance of DM Project Documentation, Data Review listings specifications, coordinate with the EDC programmer for Protocol Amendment updates in EDC. Query management, Data Reconciliations.

Therapeutic Experience

  • Neurology, Parkinson's Disease, Investigational Laboratory Research (Pre-clinical study)
  • Alzheimer's Disease, Clinical Data Reviewer
  • Narcolepsy, Clinical Data Reviewer
  • Endocrinology, Diabetes Mellitus Type 2, Investigational Laboratory Research (Pre-clinical study)
  • Cardiovascular, Dyslipidemia, Lead Clinical Data Manager, Hypertriglyceridemia
  • Infectious Disease, Influenza A (H1N1), Lead Clinical Data Reviewer
  • Dermatology, Postherpetic Neuralgia, Clinical Data Reviewer
  • Ophthalmology, Diabetic Macular Edema, Lead Clinical Data Reviewer
  • Other, Fabry's Disease, Lead Clinical Data Manager
  • Oncology, Chronic Lymphocytic Leukemia, Lead Clinical Data Manager Backup, Solid Tumor Configuration, Lead Clinical Data Manager Backup Lead Clinical Data Manager, Malignant Tumor of Ovary, Lead Clinical Data Manager

Publications Doctoral Thesis

  • Severity of Dyskinesia and D3R Signaling Changes Induced by L-DOPA Treatment of Hemiparkinsonian Rats Are Features Inherent to the Treated Subjects by Sacnité Albarrán-Bravo, José Arturo Ávalos-Fuentes, Hernán Cortés, Marina Rodriguez-Sánchez, Norberto Leyva-García, Claudia Rangel-Barajas, David Erlij and Benjamín Florán. Biomolecules 2019, 9(9), 431; https://doi.org/10.3390/biom9090431
  • Dopaminergic denervation switches dopamine D3 receptor signaling and disrupts its Ca2 + dependent modulation by CaMKII and calmodulin in striatonigral projections of the rat by Arturo Avalos-Fuentes, Sacnité Albarrán-Bravo, Santiago Loya-Lopéz, Hernán Cortés, Sergio Recillas-Morales, Jonathan J. Magaña, Francisco Paz-Bermúdez, Claudia Rangel-Barajas, Jorge Aceves, David Erlij, Benjamín Florán. Neurobiology of Disease, Volume 74, February 2015, Pages 336-346.
  • Pathophysiology of L-Dopa Induced Dyskinesia ? Changes in D1/D3 Receptors and Their Signaling Pathway" "A Synopsis of Parkinson's Disease by Sacnité Albarrán-Bravo, Claudia Rangel-Barajas and Benjamín Florán. IntechOpen. Submitted: September 12th 2013Reviewed: September 20th 2013Published: March 26th 2014. DOI: 10.5772/57102

Business Title

Lead Clinical Data Manager

Certification

DIACR Qualified Clinical Research Data Associate

Timeline

DIACR Qualified Clinical Research Data Associate

04-2024

Lead Clinical Data Manager

IQVIA and its Affiliated Companies
10.2020 - Current

Senior Clinical Data Associate

Syneos Health
11.2019 - 10.2020

Clinical Data Associate III

Syneos Health (Formerly INC Research)
11.2018 - 10.2019

Clinical Data Associate II

Syneos Health (Formerly INC Research)
05.2017 - 11.2018

Clinical Data Associate I

INC Research, LLC
11.2015 - 05.2017

University Teacher

Biology Faculty in Iztacala UNAM
02.2015 - 08.2020

University Teacher

School of Chemistry and Pharmacology at UMSNH
02.2008 - 08.2010

Ph.D. - Neurosciences-Parkinson's Disease

CINVESTAV, Mexico
05.2001 -

Master of Science - Experimental Biology

Chemistry And Biological Research Institute, UMSNH
05.2001 -

Bachelor of Science -

School of Chemistry And Pharmacology, UMSNH
05.2001 -
Sacnite AlbarranData Team Lead (DTL)