Data Management Office Manager
Resume:
Brenda Troth
Bertram, Tx. *****
Phone: 512-***-****
*******@*****.***
Summary of Qualifications
Professional Experience
Served as Office Manager for 10 yrs with ARC Abatement
Payroll, Expenses, Per Diem, Coding, Job books on operating system Field Flo, filing, answering phones, TDH notices setting up hotels, ordering supplies and keeping the office running smoothly.
Served as Clinical Data Management for 20 years. Senior Lead on multiple protocols.
Experience includes a combination of Cardiac, Infections Blood Disease, Neurology, Endocrine, Digestive System, Dermatology and Oncology trial management experience.
Clinical data management experience includes working knowledge of several database platforms
Data Management tasks have included: Sponsor contact and communication, study start up. Investigator meetings, creating, designing CRFs, creating edit specification, creating data validation guidelines, validating. As well as test data, contacting sites for follow-up regarding queries, run and review SAS listings, auditing project databases, writing final QC reports and successfully locking databases upon completion of trial study.
Reviewed confidential disclosure agreements, regulatory documents and contract/budgets as required for site initiation, per job protocols.
Therapeutic Experience
Cardiac: COPD, Ventricular cardiac rhythm
Infections Blood Disease: Sepsis, MRSA (Methicillin-resistant Staphylococcus Aureus)
Neurology: Schizophrenia, Bipolar
Endocrine: Erectile Dysfunctions, Urinary Tract Disorders
Digestive System: Functional Digestive Disorders (IBS, IBD, Crohn’s Dyspepsia)
Dermatology: Psoriasis and Eczema
Oncology: Multiple Myeloma
Pain
Professional Experience
ARC Abatement
Office Manager
January 5th 2015 – January 31st 2025
Answering incoming high call volume phones, direct it to correct personal.
All filing
Creating job books in database (FF) Field Flo for work progress to be recorded daily
Payroll
Expenses
Per Diem
TDH 10 day notices
Hotel Reservations
Ordering Supplies
Reading writing job proposals
Coding of all applicable supplies
Maintaining Office is running smoothly
Self Employed
September 2013-2015
Started my own cleaning business on residential homes. Truly enjoyed my work and pleasing people. Only did it long enough to get my son through high school onto graduation, as we were flood victims and up rooted from our home and normal life.
Quintiles
Senior Project Manager (remote)
July 2012-2013
Ensures the contracted Data Management for clinical studies are carried out by current research team in accordance with the executed contract and the customer’s expectations.
Direct liaison with Finance and Contract department on required matters (e.g. invoicing, contract changes, etc.
Primary contact for internal liaison between Data Management and Project Management, Clinical Monitoring and other functional groups on ‘full service’ contracts; Ensures launch, delivery and completion of all Data Management task according to contractual agreement and relevant SOPs, guidelines and regulations.
Manages changes of scope of work, budget, revenue recognition and participation in monthly internal project reviews.
Manages changes of scope of work, budget, revenue recognition and participation in monthly internal project reviews.
Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.
Plans, manages and requests resource as required for assigned studies.
Develops and maintains:
oData Management Plans;
oProject Management Plans (for standalone contracts only)
Mentor, motivate and supervise data management staff
Perform Clinical Data Management (CDM) review of all study subject information captured during the conduct of clinical study
Work with project team and comply with all Standard Operating Procedures (SOPs) Work Instructions (WIs) regulatory guidelines and directives and study specific plans pertaining to collection, review and management of clinical study data.
INC Research
Project Manager, Data Management
September 2009-2012
Ensures the contracted Data Management for clinical studies are carried out by INC Research in accordance with the executed contract and the customer(s) expectations.
Direct liaison with Finance and Contract department on required matters (e.g. invoicing and contract changes.
Primary contact for internal liaison between Data Management and INC Project Management, Clinical Monitoring and other functional groups on ‘full service’ contracts; Ensures launch, delivery and completion of all Data Management according to contractual agreement and relevant SOPs, guidelines and regulations.
Manages changes of scope, budget, revenue recognition and participation in monthly internal project reviews.
Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.
Plans, manages and request resource as required for assigned studies.
Develops and maintains:
oData Management Plans;
oProject Management Plans (for standalone contracts only);
Mentor, motivate and supervise data management staff
Perform Clinical Data Management (CDM) review of all study subject information captured during the conduct of clinical study
Work with project team and comply with all Standard Operating Procedures (SOPs) Work Instructions (WIs) regulatory guidelines and directives and study specific plans pertaining to collection, review and management of clinical study data.
INC Research
Clinical Data Associate III
September 8, 2008 – September 2009
Mentor, motivate and supervise data management staff
Perform Clinical Data Management (CDM) review of all study subject information captured during the conduct of clinical study
Work with project team and comply with all Standard Operating Procedures (SOPs) Work Instructions (WIs) regulatory guidelines and directives and study specific plans pertaining to collection, review and management of clinical study data.
Create data management timelines with project team based on productivity standards and sponsor expectations.
Define expectations, roles and responsibilities of data management team members and provide realistic team goals on a regular basis.
Chiltern International
Sr. Clinical Data Associate
April 2007-June 2008
Acted as a Lead Clinical Data Manager for multiple projects, also provided support to other Lead Clinical Data Managers for one or more projects
Liaison with clients and colleagues in other functional groups as required.
Fulfilled all data management cleaning activities in accordance with the Data Validation Guideline (DVG) and/or client documentation.
Designated tasks appropriately within the team ensuring all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and DVM, DVGs.
Represented Clinical Data Management at internal and external meetings and presentations
Chiltern International
Sr. Data Manager
August 2006-January 2007
Acted as a Lead Clinical Data Manager for multiple projects, also provided support to other Lead Clinical Data Managers for one or more projects
Liaison with clients and colleagues in other functional groups as required.
Fulfilled all data management cleaning activities in accordance with the Data Validation Guideline (DVG) and/or client documentation.
Designated tasks appropriately within the team ensuring all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and DVM, DVGs.
Represented Clinical Data Management at internal and external meetings and presentations
Nustats International
Sr. Data Analyst
November 2005- August 2006
Acted as a Lead Clinical Data Manager for multiple projects, also provided support to other Lead Clinical Data Managers for one or more projects
Fulfilled all data management cleaning activities in accordance with the Data Validation Guideline (DVG) and/or client documentation.
Designated tasks appropriately within the team ensuring all work conducted were completed
Assent Consulting
Clinical Data Manager
November 2004 – July 2005
Acted as a Lead Clinical Data Manager for multiple projects, also provided support to other Lead Clinical Data Managers for one or more projects
Liaison with clients and colleagues in other functional groups as required.
Fulfilled all data management cleaning activities in accordance with the Data Validation Guideline (DVG) and/or client documentation.
Designated tasks appropriately within the team ensuring all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and DVM, DVGs.
Represented Clinical Data Management at internal and external meetings and presentations
PPD
Sr. Clinical Data Analyst
April 1 1993 – September 2004
Sr. Clinical Data Manager for multiple projects, also provided support to other Lead Clinical Data Managers for one or more projects
Liaison with clients and colleagues in other functional groups as required.
Fulfilled all data management cleaning activities in accordance with the Data Validation Guideline (DVG) and/or client documentation.
Designated tasks appropriately within the team ensuring all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and DVM, DVGs.
Represented Clinical Data Management at internal and external meetings and presentations
Mentor, motivated and supervised data management staff
Performed Clinical Data Management (CDM) review of all study subject information captured during the conduct of a clinical study trail.
Work on project team and comply with all Standard Operating Procedures (SOPs) Work Instructions (WIs) regulatory guidelines and directives and study specific plans pertaining to collection, review and management of clinical study data.
Create data management timelines with project team based on productivity standards and sponsor expectations.
Define expectations, roles and responsibilities of data management team membres and provide realistic team goals on a regular basis.
EDUCATION
Mansfield Business College, Austin Tx.
Associate Degree in Business Administrative Specilalist, 1990-1992
Medical Terminology, Austin Community College, 1996
Coding Specialist, Austin Community College, 1998
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