Project Manager Management

Elaine Vernot (B.S in Biology, M.S. Management/Project Management)

Dacula, GA 770-***-**** ady4w0@r.postjobfree.com

Clinical Trial Manager/Project Manager/Medical Device Reporting Agent

PROFESSIONAL SKILLS & STRENGTHS

Highly skilled in the coordination and management of clinical projects and delivery of high quality data throughout the project life cycle.

Knowledge of project management processes and tools (MS Project).

Excellent leadership, project management, presentation and organization skills.

Ability to review and approve investigations performed by the manufacturing site or OEM supplier.

Experience in User Acceptance Testing (UAT) of clinical trial databases assuring compliance with protocol and institutional processes, procedures and Database setup. Medical Device reporting electronically, initial and follow-ups, Vigilance reporting

Ability to coordinate clinical trial site management activities including scheduling and management of site visits. Experience with trial master files (TMF) for studies. Purchasing lab materials and reconciling invoices.

Experience in Audit, investigations, business analysis, customer relations and problem solving.

Working knowledge of GCP, ICH-9, CRF-Part-11, SAS. Ability to work independently and group.

Ability to track overall progress, key project milestones, adjust project plans to meet customer needs.

Multi-tasking skills with demonstrated ability to manage expectations and deliver results.

Ability to develop and maintain good working relationship with team members and customers.

Computer Skills: PC, MAC, MS Office Tools (Excel, Word, Outlook, Access, PowerPoint & Project), Oracle Clinical and RAVE EDC, SAS, SQL, SharePoint, PeopleSoft, Dashboard, Trackwise. ETQ System, Electronic Filing, MS Project, Celoxis, CRM

Pharmaceutical/Medical Device Skills: CDISC, STDM, LOINC codes, GCP, ICH-9, CRF-Part-11, Queries, DCF’s, Setup Databases, QSR and ISO13485, Medical Device Reporting FDA submission, FTP: FileZilla, ASCII, Binary

PROFESSIONAL EXPERIENCE:

Winder Laboratories, Winder Ga. Project Manager (Dec. 2019 -Jan. 2020)

Lead multiple concurrent small, mid-sized or large projects ensuring that project deliverables are compliant with all applicable regulations including FDA, cGMPs,and 21 CFR Part 11.

Coordinated project activities with Director and lab team.

Worked with construction vendors, AC vendors and several manufacturing vendors to organized completion of manufacturing construction for laboratory validation.

Setup meetings, took meeting minutes and distributed them to the management team. Assisted with arranging internal laboratory audits.

Ordered manufacturing supplies for production of pharmaceutical drugs. Reconciled invoices with supplies ordered.

WuxiApptec, Inc. Marietta, Ga Operation, Project Manager (Jan. 2017- Sept 2019)

Managed one or more highly complex technology projects or programs that span multiple areas and business functions, in addition to handling medium to smaller projects.

Managed Key accounts and Produces Metrics for Each Accounts Performance. Work with key accounts to expand business relationship.

Managed Custom Schedules for clients and operations

Proactively managed changes in scope through a change control process

Provided Custom Quote and Proposal Development with Ownership and accountability for bringing Project to Fruition

Participated in Revenue Forecast Communications and Testing Forecasts to Senior Management

Lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical staff and business development staff.

Kept clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.

Maintained project documentation - communications, schedules, sample submission paperwork, meeting minutes, etc.

Informed internal resources of project updates / timely communications

Provided Custom Quote and Proposal Development with assistance of Technical Team

Ensured that testing is performed as per executed contract and brings all scope changes to the attention of management.

Performed client billing upon completion of report. Invoiced Projects as per the executed contract. Worked with minimal to no supervision act

Fountain Group (Halyard Healthcare) Medical Device Reporting Agent (Aug. 2016-Dec. 2016)

Prepared and submitted all MedWatch Reports, both Initial and Follow-up reports, to the FDA in compliance with regulations, guidelines and the required timeframe. Online electronic filing.

Assured accuracy, integrity, completeness and consistent content of all product complaint investigations and MDR and Vigilance reports.

Receive and evaluate product complaints for FDA, EU, Canadian and other Health Regulatory Authorities as required for reporting requirements.

Interfaced with Global Clinical Affairs staff to appropriately executed Vigilance Reports internationally.

Maintained records from FDA Medical Device and International Vigilance Report investigations that are submitted.

Took responsibility for maintaining efficient Medical Device Report work flow and work assignments to achieve complete and timely closures.

Provided data analysis of files and reporting logs as required.

Interfaced with internal and external customers to obtain additional information for complaint files.

Assured that medical reviews and reportability reviews are completed in a timely manner for submission.

Participated in FDA and ISO audits if required or as needed. Performs all other related duties as directed by management.

Elaine Vernot (page 2)

770-***-**** ady4w0@r.postjobfree.com

CR Bard (Alpha Scientific) Legal Field Assurance Specialist: (Sept 2014 – Aug 2016)

Performed complaint and quality investigations related to manufacturing, design or clinical use issues.

Reviewed and approve investigations performed by the manufacturing site or OEM supplier. Ensure consistency and attention to detail in performing and documenting complaint investigations. Maintain the records of all Medical Device Report and document rationale for not filing MDRs.

Performed final review for closure of complaint files to ensure accuracy, completeness, and attention to details. Generated results letters to customers.

Approved vigilance/international competent authority reports. Approve decision trees for vigilance reports/international competent authority. Review Medical Records and submit MDR’s to the FDA. Review and monitor trending codes. Training in QSR and ISO13485.

Quintiles Laboratories (Q2) Clinical Data Analyst/Clinical Team Lead (May 2007 – Apr. 2014)

Managed delivery of projects through full data management study life cycle.

Performed comprehensive quality control procedures and collaborated with Stakeholders to establish appropriate strategies. Presented at lab audits and Bid defense.

Provided input on negotiations with customers, independently brought project solutions to the Laboratory Data Management team. Participated in internal and external audits.

Verified log errors generated through our LIMS for Data Transmission that creates programs.

Worked with Project Manager (PM) to define program targets for clinical operations staff and assured work is documented within contracted project scope.

Produced ad hoc files upon request. Created and or/reviewed all appropriate data management documents. Utilize SAS and SQL produce files and setup databases.

Interacted with internal and external team members to negotiate timelines. Utilized PeopleSoft to manage studies, documents and study work metrics.

Developed and maintained good communications working relationship with team, knowledge of GCP, ICH-9, CRF-Part-11 and reviewed SOP’s provided input. Provided risk management of the database, strategic planning, setup and monitored timelines, validated data, assured data available for retrieval.

Trained and mentored junior staff in Data Management expertise. Worked with sponsors and project management team to design and setup databases and data requirements documents to export data. Generated, uploaded ASCII data transmission files according to specifications and worked with clients setting up CDISC and STDM files.

UCB Pharmaceutical Clinical Data Coordinator/Project Coordinator: Dec. 2005 – Feb.2007

Created and reviewed test patient data, based on the Data Cleaning Plan, to establish documented evidence to ensure a high degree of assurance that the clinical programming meets the required specification. Reviewed and interpreted data discrepancy output, as well as performing manual listing reviews and generating data queries to be sent to the investigational site, following new company standard conventions and procedures, GCP, ICH-9, CRF-Part -11.

Interpreted data cleaning specifications, created/troubleshooting clinical data to ensure the validation of the programming, and managed the data cleaning process for a study, provided risk management of the database, strategic planning. Established and maintained successful professional relationships with key stakeholders to improve research programs and outcomes.

Interpreted/troubleshoot test patient data to ensure the accuracy of the programming of the validation checks. Interpreted clinical site investigator responses to queries on the data and making appropriate judgment as to whether the responses are sufficient.

Updated database after Data Clarification Forms returned from investigators and conducted Data Quality Review Meeting. Uploaded Lab Data to Oracle database from CD’s and the internet, Generated and QC’d reports and delivered reports (tables and listings) to Statisticians for review and submission to the FDA

EDUCATION:

Certificate in Project Management-Basics

GoSkill online

Master of Science in Management, concentration in Project Management

Strayer University, Roswell, GA

Bachelor of Science in Biology (B.S.)

Shaw University, Raleigh, NC

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