Project Management North Carolina
Resume:
Vanessa Evans
Creedmoor, North Carolina 27522
**********@*****.***
PROFESSIONAL EXPERIENCE
IQVIA
March 2023-June 2025
Regulatory Start-Up Specialist
Served as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensured adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Performed start up and site activation activities according to applicable regulations, SOPs and work instructions. Distributed completed documents to sites and internal project team members.
Prepared site regulatory documents, reviewing for completeness and accuracy.
Ensured accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Reviewed and provide feedback to management on site performance metrics.
Reviewed, established and agreed on project planning and project timelines. Ensured monitoring measures were in place and implemented contingency plans as needed.
Informed team members of completion of regulatory and contractual documents for individual sites.
Reviewed, tracked and followed up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provided local expertise to SAMs and project team during initial and on-going project timeline planning.
Performed quality control of documents provided by sites.
Direct contact with sponsors on specific initiatives.
IQVIA
September 2016-March 2023
September 2016-September 2017 (Contractor)
Site Site ID Specialist
Took independent responsibility for assigned site identification projects.
Assisted Site ID lead on projects with increased protocol complexity, site
numbers and/or customer SOPs or processes.
Utilized historic site performance metrics, cluster sites, partner sites,
feasibility data, and other data to identify potential sites.
Submitted and reviewed investigators for quality assurance status as applicable.
Tracked all project activities in Database system.
Managed template documents for Confidential Disclosure Agreements
(CDAs) and Site Information Forms (SIFs).
Distributed, tracked and negotiated the Confidential Disclosure Agreements
(CDAs) with assistance from Management / Legal as appropriate.
Distribute, tracked and reviewed Site Information Forms (SIFs) for
completeness, site capability and availability.
Provided project progress reports to Internal and External project teams
INC Research
July 2016-September 2016
Project Specialist I (Contractor)
Supported Project Manager (PM) to ensure the contracted services and
expectations of a clinical study were carried out by the assigned project team
in accordance with the executed contract and the Customer’s expectations.
Tracked and analyzed project details. Maintained internal systems for
assigned projects within a therapeutic area. .Assured compliance with local
regulations, Code of Federal Regulations/International Conference of
Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and
Company and Sponsor Standard Operating Procedures (SOPs). Oversaw
regulatory documentation according to Essential Regulatory Document
Guidelines and Trial Master File (TMF). Conducted secondary review of the
Essential Regulatory Documents. Served as project representative for
internal and external TMF audits.
Trialcard Inc.
November 2015-July 2016
Program Specialist I (Contractor)
Assigned and/or processed EOBs and/or Enrollments for various programs.
Entered data into specific computer programs with accuracy and in a timely
manner. Reviewed and decided what specific action was required for a
document. Recognized and reported information as required by a client
(i.e.,Adverse Events).Completed special projects as assigned by
management. Trained new hires as requested. Received and processed
incoming mail. Processed outgoing mail via USPS or express mail (FedEx).
Troubleshot returned mail such as but not limited to patient/site letters
patient, checks and debit cards. Enrollments for various
Biogen
September 2013-November 2015
Senior Patient Data Coordinator
Received incoming documentation from patients, physician offices and other sources that authorized the enrollment of individuals into the services of Patient Services. Reviewed the received information for completeness and accuracy. Entered data into Siebel from multi-page documents while using technology simultaneously for availability to Case Managers and other Patient Services employees. Maintained thorough knowledge of SOPs, frequently changing job aids and process changes. Contacted physician offices to retrieve complete and accurate enrollment forms to initiate the case management process. Consulted and communicated with Case Managers on accuracy of information. Researched inaccurate and incomplete information by querying the database for pending information. Mentored employees on the processes and procedures of the department.
BioMerieux
July 2013-September 2013
Data Entry Associate (Contractor)
Supported data collection and entry efforts by collecting data from multiple sources by scanning or copying, organizing, and storing documents, and cross-checking documents for accuracy prior to entry. Performed data entry activities, including entering data from collected sources into an identified computer database, compiled and rearranged data from multiple sources, performed quality checks for accuracy, and maintained records in designated location.
Novella Clinical, Inc.
February 2013- March 2013
Client File Auditor (Contractor)
Audited files against CRF information in the database for accuracy and consistency.
Query resolution. Researched all discrepancies to provide information to the sponsor for possible changes needing to be made.
PharPoint Research, Inc.
July 2010- November 2012
Clinical Data Associate II, Data Management (Permanent)
Clinical Data Associate II, Data Management (Contractor)
Reviewed study specific documentation as part of the project team to obtain understanding of study specific data processing conventions. Prepared data for entry, through completion of transmittal verification, data tracking, and completion of manual review processes. Performed data entry in any clinical data management system used by Clinical Data Management. Conducted quality control including case report form to database review processes. Reported routine project status and data trends to project lead or departmental management as required. Performed Medical Coding. Issued and resolved site queries. Resolved database validations.
BioMerieux Inc.,
May 2010-July 2010
Data Management Specialist, Data Management
Controlled, reviewed and processed all data generated at the clinical sites and ensured the integrity and accuracy of the data entered into the clinical database. Entered data from case report forms, designed such CRF’s from study requirements. Generated data queries, and maintained study data documentation, including document control and archiving.
Health Decisions, Inc.
September 2008-November 2009
Data Manager
Handled study maintenance and close-out DM activities Completed Data Entry activities as necessary. Managed coding activities. Trained monitors and site coordinators in correct CRF completion. Troubleshot proprietary data management software, worked actively in project team environment by participating in internal and client meetings, reporting project status to project /functional management. Mentored and trained junior staff members. Communicated effectively with sites and site monitors to process queries.
Health Decisions, Inc.
April 2007- September 2008
Data Coordinator II
Created, implemented, validated, documented, reviewed and/or maintained efficient data entry for clinical databases. Performed quality control of clinical databases and reviewed critical variables. Issued queries to sites or monitors. Performed routine tasks of tracking case report forms.
Quintiles Inc.
October 2006-March 2007
Documentation Coordinator CEVA, (Contractor)
Performed CEVA project filing tracking and archiving. Pre-processed material for endpoint committee or core laboratory adjudication including. Tracked all material received for adjudication Notified CEVA Lead of any missing, required material for submission. Provided, assembled material to CEVA Lead for secondary review. Executed administrative aspects of committee and laboratory management.
Duke Clinical Research Institute
November 2005-October 2006
Clinical Data Assistant III (Contractor)
Performed a variety of technical database duties of a complex nature in support of multiple clinical trials. Generated and resolved queries on clinical trials data. Contacted sites to obtain data clarification as required. Performed routine quality control checks as specified in the Quality Control Plan. Assisted the CDS Specialist in the creation of trial specific forms. Identified problems in query/discrepancy management. Processed and made recommendations for improvement. Communicating effectively with sites and site monitors to process queries from generation to resolution. Participated in the execution of test plans for data integrity checks.
Quintiles Inc.,
November 2002-January 2005
Sr. Data Coordinator
Provided solid basic and comprehensive data management expertise to the department to offer efficient, quality data management products that met client’s needs. Provided leadership to the team as the CDM Lead. Performed comprehensive data management tasks and comprehensive QC. Assisted other team members in training and in developing data management expertise. Assigned codes to investigator descriptions of adverse events, medications, procedures, and diagnoses for subjects participating in clinical trials, using automated coding systems (WHO Drug & MedDRA) for dictionary auto-encoding and coding entry adhering to project specific guidelines.
Clinical Coding Associate- November 1998-November 2002
Assigned codes to investigator descriptions of adverse events, medications, procedures and diagnoses for subjects participating in clinical trials, using automated coding systems (WHO Drug) for dictionary auto-encoding and coding entry adhering to project specific guidelines. Attended project team meetings as the Clinical Coding representative. Developed project specific coding guidelines. Performed quality review data coded via the auto-encoder or manually.
Triangle Hospice, Inc.
April 1996 - November 1998
Accounts Receivable/Billing Specialist
Performed CPT & ICD-9 coding. Gathered & processed statistical information for the Chief Financial Officer. Processed contractor invoices for Accounts Payable. Performed billing process for the organization. Processed Accounts Receivables collections. Negotiated billing rates with insurance companies
COMPUTER SKILLS
Clintrial, Medidata Rave, Windows, Excel, Outlook, PowerPoint, Access, Medrio, Sharepoint, Florence, TMF, DrugDev, Clinical Analytics, Citeline
THERAPEUTIC AREA EXPERIENCE
·Oncology
·Respiratory
·Dermatology
·Endocrinology, including Diabetes
·Cardiology
·Pain Management
·Gastrointestinal Disorders
·Device Studies
·Ophthalmology
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EDUCATION
Durham Technical Community College (Attended) 1987-1988
Business Administration
North Carolina Central University (Attended) 1985-1987
Business Administration
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