Clinical Manager Data

Ivan Valverde

***** *** *** ***

Germantown, MD *0874

***************@*****.***

Summary

Knowledgeable and motivated Clinical Data Manager with experience working on complex clinical trials (in-house and outsourced), electronic, to include phase I-IV in different types of therapeutic areas.

Therapeutic Experience:

Infectious/Parasitic Disease: HIV, West Nile Virus, Anthrax, Atherosclerosis

Endocrine/Metabolic: Diabetes, Gout

Hematology: Deep Vein Thrombosis (DVT)

Dermatology: Psoriasis, Anti-fungal

Musculoskeletal: Osteoarthritis

Antibody: Multiple Sclerosis, Bleeding Disorder

Gastroenterology: Celiac Disease, Chronic Kidney Disease, Prostones

Cardiovascular: Hypertension, Stent

Oncology: HCC

Pediatrics: Constipation

Rare Disease/Orphan Disease: Phenylketonuria, Niemann-Pick Disease

Employment History:

Clinical Data Manager II, WuXi Apptec, Apr-2020 - Present

Responsibilities include:

Provide operational support for Data Operations

Serve as data management lead interacting directly with sponsor, sites and vendors on medium complexity paper-based or EDC projects with moderate to minimal supervision

Accountable for all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database

Function as the primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trial

Perform and accountable for all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database

Ensure approved study documentation is maintained and properly stored in the trial master files

Perform Business Development functions including but not limited to attendance and participation in client meetings

Notify project manager and supervisor of any potential out-of-scope requests or work issues that will affect project budget or timelines

Managing processes to ensure data integrity via appropriate data management processes, such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data or query quality checks, ensuring database updates are applied, etc.) in accordance with approved study documentation

Good understanding of departmental and company procedures which relate to tasks that are performed routinely

Working for Glaxo Smith Kline through Syneos Health (Contractor)

Sr. Clinical Data Manager, Syneos Health, Rockville, MD, Feb-2019 – Apr-2020

Responsibilities include:

Developed data management QC plans and quality control checks

Developed Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications working EDC/SAS programmers

Created UAT plans, Test Script and delegated execution of testing

Reviewed and approved vendor contracts change orders and invoices

Interacted with Sponsor and team on daily basis with updates and meetings to provide input on the ongoing process for each assigned study

Mentored Clinical Data Managers to follow DM Guidelines, SOP and GCP documents accordingly.

SAE and Lab reconciliation for third party data reviewed

Clinical Data Specialist II, Mallinckrodt Pharmaceuticals, formerly Sucampo Pharmaceuticals, Rockville, MD, Feb-2018 – Feb-2019

Responsibilities include:

Served as a Lead Data Manager from Study Start-up up to Database Lock

Represented Data Management in Kick Off Meeting and Request for Proposal submissions for future studies

Mentored Clinical Data Specialist to follow Data Management guidelines according to our SOP, GCP and ICH

Create CRF design spec

Oversee vendor studies and making sure timelines are met

Trained staff to perform UAT testing of clinical database according to Vendor timelines

Prepared study specific DMP, Manual Review Guidelines, External Edit Checks and CRF completion guidelines

Provided access to new users within the EDC system

Interaction with client and project team to establish data review guidelines and data flow procedures

Followed ICG guidelines, Applicable Regulatory Requirements, Good Clinical Practice, and Standard Operation Procedures

Reviewed and approved final CRF design, validation checks and reports necessary to assure high quality and consistent data

Clinical Data Specialist II, Sucampo Pharmaceuticals, Rockville, MD, Mar-2017 – Feb-2018

Responsibilities include:

Served as a Lead Data Manager from Study Start-up up to Database Lock

Represented Data Management in Kick Off Meeting and Request for Proposal submissions for future studies

Mentored Clinical Data Specialist to follow Data Management guidelines according to our SOP, GCP and ICH

Performed SAE and Third-Party Lab Reconciliation in accordance to our Data Management Plan

Coding of adverse events, medications, and other specified clinical variables for consistency throughout the study

Communicated/coordinated with project manager, statistician, clinical research associate to ensure clean database

Maintained project tracking of subjects. Updated tracking report on a monthly basis with information from EDC system

Trained staff to perform UAT testing of clinical database according to Vendor timelines

Prepared study specific DMP, Manual Review Guidelines, External Edit Checks and CRF completion guidelines

Provided access to new users within the EDC system

Worked closely with the Clinical and Biostatistics team to identify issues for timely resolution to support continuous data cleaning and on time quality database lock

Interaction with client and project team to establish data review guidelines and data flow procedures

Followed ICG guidelines, Applicable Regulatory Requirements, Good Clinical Practice, and Standard Operation Procedures

Performed SAE and Third-Party Lab Reconciliation in accordance to our Data Management Plan

Coding of adverse events, medications, and other specified clinical variables for consistency throughout the study

Reviewed and approved final CRF design, validation checks and reports necessary to assure high quality and consistent data

Clinical Data Specialist, Sucampo Pharmaceuticals, Bethesda, MD, May-2014 – Mar-2017

Responsibilities include:

Trained staff to perform UAT testing of clinical database according to Vendor timelines

Prepared study specific DMP, Manual Review Guidelines, External Edit Checks and CRF completion guidelines

Provided access to new users within the EDC system

Reviewed and approved final CRF design, validation checks and reports necessary to assure high quality and consistent data

Worked closely with the Clinical and Biostatistics team to identify issues for timely resolution to support continuous data cleaning and on time quality database lock

Interaction with client and project team to establish data review guidelines and data flow procedures

Followed ICG guidelines, Applicable Regulatory Requirements, Good Clinical Practice, and Standard Operation Procedures

Performed SAE and Third-Party Lab Reconciliation in accordance to our Data Management Plan

Coding of adverse events, medications, and other specified clinical variables for consistency throughout the study

Communicated/coordinated with project manager, statistician, clinical research associate to ensure clean database

Working for Sucampo Pharmaceuticals through GreenKey Resources (Contractor)

Clinical Data Manager, Sucampo Pharmaceuticals, Bethesda, MD, Nov 2013 – May-2014

Responsibilities include:

Review of vendors Data Validation Specifications

Review of vendors Study Design Requirement specs

Performed review of data in EDC for cleanliness

Performed lab reconciliation

SAE Reconciliation

Freeze and Locked Database

Data reviewed of case report forms, preparing forms for data entry as determined by review guidelines and standard department procedures

Working for BioMarin through Gerard Group Inc. (Contractor)

Clinical Data Manager, BioMarin Pharmaceutical Inc, San Rafael, CA, Dec 2012 – Sept 2013

Responsibilities include:

•Performed Lab reconciliation

•Reviewed of data for cleanliness and discrepancies

•Reconciliation of System Data Conflicts and Electronics Edit Checks

•SAE Reconciliations

•Attended Sub-Team meeting

•Performed Database Lock procedures

•Reviewed and Update of Data Management Plan and eCRF Completion Guidelines

Working for Novartis Pharmaceutical through Kelly Services (Contractor)

Clinical Data Manager II, Novartis Pharmaceutical, East Hanover, NJ, July 2012 - Dec 2012

Responsibilities include:

•Provided timely and professional ongoing quality management of outsourced clinical studies in support of the assigned CRO contracted to perform data management functions

•Ensured that databases can be declared clean and locked according to strict performance standards

•Worked closely with Clinical trial team, provided ongoing database status reports, proactively identified issues for timely resolution in order to support continuous data cleaning and on time quality database lock.

•Reviewed and contributed to the development of trial validation plan related documents and created and approved final CRF design, validation checks and reports necessary to assure high quality and consistent data

•Identified issues for resolution in order to support continuous data cleaning and on time quality database lock

•Reviewed and contributed to the preparation of protocols, CRF’s and contributed to operations manual

Working for Harvard Clinical Research Institute through Logix, Inc. (Contractor)

Data Manager, Harvard Clinical Research Institute, Boston, MA, Jan 2012 - July 2012

Responsibilities include:

•Served as a contact with sponsors and establishing relationship with sponsor’s management team

•Coordinating Data Clarification Forms for Project teams and paper and electronic archiving for completed projects

•Perform SAE, Lab and third party data reconciliation

•Ensure Validation of database and ready for transfer and/or database lock

•Review listings for discrepancies

•Locking forms

•QC data prior to database lock

•Established DM timelines to ensure DM project milestones are met

Clinical Data Manager, Outcome Sciences, Inc, Cambridge, MA, April 2011 - Jan 2012

Responsibilities include:

•Managed database development and data review for clinical trials and patient registry program in compliance with standard operating procedure, client guidelines, contractual obligations and regulatory agency guidelines

•Development of CRFs and eCRFS for completeness, content, standards, and database consideration

•Queried data inconsistencies in compliance with standard operating procedure, client guidelines and applicable regulatory agency guidelines

•Development of Data Management Plan, eCRF Completion Guidelines

•Writing edit checks and testscripts

•Managed and assisted with data quality audits as needed

•Performed SAE reconciliation

•Performed UAT testing

Working for Novartis Pharmaceutical through MedFocus LLC (Contractor)

Clinical Data Manager, Novartis Pharmaceutical, East Hanover, NJ, Mar 2008 -April 2011

Responsibilities include:

•Responsible for Secondary review of CRFs for safety, efficacy and Adverse Event reaction

•Reconciliation of SAE’s against database

•Track status of clinical studies reviewed

•Reviewing of patients for inconsistency and bad data

•Reconciliation of System Data Conflicts

•Reconciliation of Lab, ECG and Vital Signs

•Liaison between site and database management in clinical/technical issues

•Attend weekly TC regarding Timelines and General Questions of the study

MPI Data Entry Specialist (Part-Time Contractor), QuadraMED, Falls Church, VA September 2007 - Mar 2008

Responsibilities include:

•Organized and evaluate client patient medical records for deficiencies and merging of duplicate patient records

•Verified registration data complete all necessary tasks to create, maintain and update a complete confidential patient medical record

•Maintained a working knowledge of all basic Medical Records department policies, procedures and tasks, including HIPAA compliance

•Knowledge of IDX and Smart Merge software

•Consults medical record to verify that each record belongs to the same patient when match is questionable

•Made decisions regarding the validity of the proposed merge, identifying real duplicates, false positive matches, duplicate sets which have previously been merged and those that do not contain adequate information to make a decision to merge

Clinical Data Manager, PAREXEL International, Baltimore, MD, January 2005 - Mar2008

Responsibilities include:

•Interaction with client and project team to establish data review guidelines and data flows procedures.

•Developed project forms to meet specific project needs.

•Consult for case report form design and site instructions as necessary.

•Write CRF completion instructions for study sites.

•Coded adverse events and medications using the latest MeDRA and WHODrug.

•Review of Case Report Forms; prepare forms for data entry as determined by review guidelines and standard department procedures.

•Documented, resolved and integrated data queries.

•Completed all relevant audit trail materials.

•Reviewed data discrepancy listings, with associated data query documentation, resolution, and integration.

•Liaison between site/client and database management in clinical/technical issues.

•Tracked and reported data management status.

•Assisted in performing database audit(s) with project database manager.

•Communicate/coordinate with project manager, statistician, clinical research associate, database manager, and data support specialist to ensure clean database.

•Interaction with client as necessary.

•Worked on other duties as assigned by Associate Director of Data Management.

•Implementation of strategies to ensure timely subject recruitment.

Clinical Data Associate, PAREXEL International, Baltimore, MD, May 2002 - January 2005

Responsibilities included:

•Interaction with project team as necessary to assist in project set-up, establishing and maintaining data review guidelines and data flow procedures.

•Development of project forms to meet specific project needs.

•Coding of adverse events, medications, and other specified clinical variables.

•Data reviewed of case report forms, preparing forms for data entry as determined by review guidelines and standard department procedures.

•Data query documentation, resolution, and integration.

•Responsible for completing all relevant audit trail materials.

•Reviewed data discrepancy listings, with associated data query documentation, resolution, and integration. Liaison between site/ monitor and database management in clinical/technical issues. Tracking and reporting of data management status.

•Assisted in performing database audits(s) with project database manager. Communication/coordination with PMs, Statisticians, CRAs, DBMs, DSS.

•Interaction with clients as necessary.

Project Assistant, PAREXEL International, January 2001 - April 2002

Responsibilities included:

•Prepared regulatory documents (e.g. 1572) as directed by Project Manager.

•Provided administrative support to Project Manager (utilizing Word, Excel, PowerPoint, MS Project and other software).

•Composed professional business correspondence for Project Manager, clients and outside vendors. Coordinate all incoming and outgoing communications for the project and develop appropriate systems (i.e. follow-up systems, tracking).

•Supported other members of Project Management group as needed.

•Foster team environment by assisting other Project Assistants with questions and sharing tools/ideas. Book travel and prepare expense reports for Project Manager.

•File appropriate material in regulatory binder.

•Support Project Manager in organizing and follow-up of meetings (i.e. Technical Meetings, Internal Meetings).

•Support communication among team members with timely and accurate distribution of materials and by maintaining Project Management files and meeting minutes of key meetings.

•Maintain project tracking. Update tracking reports on a monthly basis with project information derived from TIMS reports.

•Maintain project timelines.

•Assist in training of Project Assistants and mentoring of new hires.

•Acquire additional information and skills to enhance job performance, maintain an up-to-date knowledge of PAREXEL’s systems, services, policies and procedures.

Sr. Administrative Assistant, Georgetown-PAREXEL, Washington, DC, January 2000 – January 2001

Responsibilities included:

•Provided support for the Vice President, Project Management Team and Clinical Unit. Handled travel arrangement for Vice President and Management Team.

•Created mail merge documents for Project Managers of clients.

•Worked on presentations using PowerPoint for Vice President and Managers.

•Assigned and create source codes for specific drug descriptions.

•Organized filing structure of the Clinical Pharmacology Research Unit Group and Senior Management Team.

•Helped IS team with installing network cards and troubleshoot printers.

•Handled confidential documents of clients: pending, proposal agreed and rejected.

•Created template for all office forms for better use and access.

•Provided technical support for the Vice President and Project Management Team regarding Word, Excel, and PowerPoint.

•Maintained a calendar of activities/appointments for the Team. Created slide presentations for sales meetings and training seminars.

•Submitted expenses for Vice President and Project Management team.

•Coordinated client meetings by ordering refreshments, organizing the boardrooms.

•Contacted AT&T for teleconference set up.

•Developed organizational chart and kept track of changes.

Administrative Assistant, PAREXEL-MMS, Alexandria, VA, September 1999-January 2000

Responsibilities included:

•Provided support for the Reimbursement Hotline and Patient Assistance Program Hotline.

•Created mail merge documents for managers and analysts of clients.

•Worked on presentations using PowerPoint for Directors and Managers.

•Assigned and create source codes for specific drug descriptions.

•Organized filing structure of the Reimbursement Group and Senior Management Team.

•Provided technical support for analysts regarding Word, Excel, and PowerPoint.

•Imported graphs from Harvard Graphics to Excel to be more user friendly.

•Organized all travel arrangements for the Georgetown-PAREXEL CPRU staff.

•Maintained a calendar of activities/appointments for the Director.

•Created and edited slide presentations for sales meetings and training seminars.

•Reported to coordinator all monthly reports.

•Submitted expenses for senior management.

•Coordinated client meetings by ordering refreshments, organizing the boardrooms.

•Contacted AT&T for teleconference set up.

•Developed organizational chart and kept track of changes.

Skills Section:

Beginner: SAS, SAS Enterprise Guide

Intermediate: IReview, SQL, Medidata Rave, InForm, WHODrug Sept 2012, MeDRA 16.0.

Expert: MS Office

EDC experience

Education:

High School and Some Community College credits

2001: A+ Certified, Digital Corporation

1997: Computer Business Systems and Network Administration, Computer Learning Center

Language Skills:

English: (Speak, Read, Write)

Spanish: (Speak, Read, Write)

Contact this candidate