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Emilie MBA

Clinical Operations Leader

Clinical Project Manager at IQVIA

Raleigh-Durham, North Carolina Area

Section title

Emilie MBA's Email Addresses & Phone Numbers

Emilie MBA's Work Experience

PAREXEL

Clinical Operations Leader

June 2015 to Present

Quintiles

Associate Clinical Project Manager

September 2014 to May 2015

Quintiles

Clinical Project Support Specialist

October 2013 to September 2014

raleigh-durham, north carolina area

Emilie MBA's Education

Appalachian State University

Masters Business Administration

2009 to 2010

University of North Carolina at Wilmington

Business Administration Marketing Minor in Spanish

2005 to 2009

Emilie MBA's Professional Skills Radar Chart

Based on our findings, Emilie MBA is ...

Considerate
Strong sense of self
Verbal

What's on Emilie MBA's mind?

Based on our findings, Emilie MBA is ...

50% Left Brained
50% Right Brained

Emilie MBA's Estimated Salary Range

About Emilie MBA's Current Company

PAREXEL

• Effectively communicate with internal and external customers as well as third party vendors • Manage the life cycle of the study from study start-up activities through termination and archiving tasks, and ensure milestones are achieved for each phaseProvide input to project tools, , i.e. , Central File Maintenance Plan, Monitoring Plan, recruitment/retention plans • Develop site...

Frequently Asked Questions about Emilie MBA

What company does Emilie MBA work for?

Emilie MBA works for PAREXEL


What is Emilie MBA's role at PAREXEL?

Emilie MBA is Clinical Operations Leader


What is Emilie MBA's personal email address?

Emilie MBA's personal email address is e****[email protected]


What is Emilie MBA's business email address?

Emilie MBA's business email addresses are not available


What is Emilie MBA's Phone Number?

Emilie MBA's phone (704) ***-*218


What industry does Emilie MBA work in?

Emilie MBA works in the Pharmaceuticals industry.


About Emilie MBA

📖 Summary

OBJECTIVE My goal is to be an active part in a company's growth and profitability while striving to reach personal career goals and develop new opportunities for the company and myself. RELATED SKILLS & TRAINING: - Barnette's GCP Certification, 2012, 2014 -HIPAA and GCP certification, 2011 -CPR, AED and BLS Certified, May 2011 -Received a Certificate of Completion for Hispanic Patient Recruitment through Hispanic Marketing Resources with Blaire Borthayre with a 100% pass rate, November 2010 -CTMS Champion THERAPEUTIC AREA EXPERIENCE: - Oncology - Internal Medicine (focus on GI) - RespiratoryClinical Operations Leader @ • Effectively communicate with internal and external customers as well as third party vendors • Manage the life cycle of the study from study start-up activities through termination and archiving tasks, and ensure milestones are achieved for each phaseProvide input to project tools, , i.e. , Central File Maintenance Plan, Monitoring Plan, recruitment/retention plans • Develop site selection and monitoring plans for the team • Ensure all team members have access to tools and documents • Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program • Provide leadership and direction to project team members • Evaluate and identify resourcing needs and continuously monitor over life cycle of project • Provide productivity targets to project team members • Address identified and escalated site issues and drive to closure • Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project • Ensure appropriate handover between project team members From June 2015 to Present (7 months) Associate Clinical Project Manager @ • Global and regional clinical project management experience running phase II-III trials in all phases of the project lifecycle • Participated in and contributed to strategy for bid defenses to win new business. • Creating, tracking and reporting on project timelines holding to customer deadlines and internal start-up and recruitment projections to meet customer needs. • Produce and distribute status, tracking and financial reports for internal and external team members and senior management for investigator payments and vendor invoicing. • Review budget allocation for resources and approval of third party and investigator invoices. • Serve as project contact with Sponsor and internal project team to ensure communication is maintained and reporting schedules are adhered to throughout the project lifecycle. • Coordinate data gathering for the development of proposals for new work including scope change form management, tracking and Sponsor approvals. • Prepare and present project information at internal and external meetings including but not limited to kick-off meetings, investigator meetings, face-to-face and weekly team calls. • Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes. • Train and coordinate the work of more junior project support staff within varies departments including clinical operations, clinical project management, and other functional groups. • Manage third party vendors. • Management of global digital patient recruitment strategy • Oversee site compliance issues and clinical quality action plans as necessary. • Serve as the CRA main point of contact. • Preparation and execution of site and internal training materials and training sessions. • Creation and monthly management of program level monthly report for internal and external users • Review and approval of site visit reports. From September 2014 to May 2015 (9 months) Clinical Project Support Specialist @ • Establish and maintain all project documentation including all files, records and reports according to the scope of work and SOPS. • Assist with periodic review/audit of files for accuracy and completeness. • Coordinate and track all information, communications, documents, materials and supplies for assigned projects. • Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information. • Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing, and interpretation of financial figures which may lead to identification of out of scope activities not previously reported. • Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices. • Prepare presentation materials for meetings (internal/external) and project summary data. • Coordinate project team and/or customer meetings including logistics and materials required. • Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes. • Serve as primary backup contact for internal project team and for external stakeholders/customers as designated by project manager. • Undertake project management activities as directed by project manager. • Review and approve site visit reports • Assist in third party vendor management activities • Global program lead for CPM support staff including mentoring of new staff and delegation of tasks within the project team • Authoring of project instructions to ensure team compliance on program processes From October 2013 to September 2014 (1 year) raleigh-durham, north carolina areaSr. Clinical Trial Assistant @ • Received 6 special achievement awards for out-of-scope work and performance on sponsor audits, database locks, etc • Performance of in-house clinical monitoring activities. • Maintain and manage data entry into a clinical tracking system in accordance with project requirements. • Serve as a central contact for designated clinical and/or project communications/correspondence and associated documentation. • Maintain central investigator files in accordance to study and Quintiles SOPs. • Complete regular and accurate tracking of documents according to project guidelines. • Regularly and accurately file study-related documents and ensure that files are audit-ready on short notice. • In-house monitoring of data flow • In-house query management • Manage AUL for study team and site access • Provide sponsor requested reports on a bi-weekly and monthly basis including, but not limited to: CRA Site Visit Performance, Protocol Deviations, Document Tracking, Detailed Recruitment Logs • Perform sponsor specific training of TMF and work instructions to fellow CTAs, project managers, and sponsor counterparts • Selected as a CTA "buddy" for new employees From August 2012 to October 2013 (1 year 3 months) Clinical Trial Assistant @ * Named CTA of the Quarter, 1st Quarter 2012 • Maintain and manage data entry into a clinical tracking system in accordance with project requirements. • Serve as a central contact for designated clinical and/or project communications/correspondence and associated documentation. • Maintain central investigator files in accordance to study and Quintiles SOPs. • Complete regular and accurate tracking of documents according to project guidelines. • Regularly and accurately file study-related documents and ensure that files are audit-ready on short notice From December 2011 to August 2012 (9 months) Marketing Representative @ -Design and develop marketing plans and materials, at a large scale multi-family housing community, aimed to generate new prospects and maintain resident retention -Provide excellent customer service to prospects; close leases, process applications, and prepare lease document packages -Maintain a professional but approachable relationship with residents; resolve disputes and enforce company policies -Assist the property manager with invoice and budget management, resident communication, rent and debt collection and contract scheduling From August 2011 to December 2011 (5 months) Business Development, Marketing & Data Manager @ -Business development, marketing and data management on a multitude of research studies including but not limited to: hypertension, obesity, hypercholesterolemia, seasonal allergic rhinitis, osteoarthritis, chronic pain, chlamydia, acne, atopic dermatitis, migraines, post-herpetic neuralgia, fibromyalgia, cosmetic dermatology, toenail fungus, overactive bladder, smoking cessation, gout, hemorrhoids, binge eating disorder, and birth control -Lead data management over numerous clinical trials in various phases of implementation including quality assurance, data entry, query resolution and management, pharmaceutical and CRO site contract point for data management issues pertaining to site -Clinical site trial data management, including randomization privileges, in various programs including but not limited to: Inform, TrialMaster, OmniComm Systems, Axiom, BioClinica, Medidata Rave, Oracle, DataLabs, Phase Forward and sponsor specific EDC platforms -Performed source document (including informed consents), paper CRF, and electronic EDC quality control and assurance for study specific documents for all coordinators at site -Regulatory responsibilities include site initiation visits, data management training, ongoing site-specific regulatory document submissions -Site start-up responsibilities include submission of 1572s, financial disclosure forms, investigator CVs and licensures, site submission documents, and advertisements to IRBs, sponsors, and CROs -Maintain ongoing communication with Data Management Teams on multiple clinical trials to ensure online database lock deadlines are met and ensure timely data query entry resolution -Secure document archival and off-site study document retrieval and storage -Design and track patient recruitment materials: print advertisements, radio scripts, TV scripts, web, email -Update and maintain social media pages -Perform updates on company webpage in order to optimize SEO on company website From July 2010 to August 2011 (1 year 2 months) Research Assistant @ - Gathered and organized green information technology and information systems research for 10 different projects for three professors in the Computer Information Systems department - Performed office duties- answering phones, organizing paperwork, handling day-to-day office responsibilities - Developed PowerPoint presentations for conferences and other academic gatherings - Edited academic papers before submission to conferences and journals - Received a $1,200 research grant to purchase EcoButtons for 100 of the the Walker College of Business computers to observe the energy consumption and monetary savings From January 2010 to May 2010 (5 months) Manager @ - Oversaw on-site management of apartment complex with 21 units - Carried out office administration duties- answering phones, collecting rent, organizing paperwork, filing, bank deposits - Assisted with accounting- accounts receivable and accounts payable - Helped with apartment change over- painting, cleaning carpet, cleaning apartments, and general maintenance duties From June 2000 to May 2010 (10 years) Server @ - Maintained appearance of the restaurant - Demonstrated cash register operation and inventory control From June 2009 to April 2010 (11 months) Sales Associate @ - Executed store opening and closing, receipt management, cash register operation, inventory control, maintenance of store appearance and cleanliness, and sales assistance in an upscale specialty clothing and shoe store - Readily adapted and exceeded expectations to a demanding work environment - Developed and maintained ongoing relationships with repeat customers - Assisted with marketing efforts- advertising, email marketing, promotions, sales, open house, trunk shows - Designed and executed store displays- clothing on manikins, window displays, jewelry displays, counter organization, holiday décor, shoe displays From July 2005 to May 2009 (3 years 11 months) Ski instructor @ From November 2003 to March 2005 (1 year 5 months) Masters, Business Administration @ Appalachian State University From 2009 to 2010 Business Administration, Marketing, Minor in Spanish @ University of North Carolina at Wilmington From 2005 to 2009 Emilie MBA is skilled in: CRO, CTMS, Clinical Trials, Clinical Development, EDC, GCP, Marketing, Sop, Data Management, Clinical Research, Protocol, SOP, ICH-GCP, Oncology


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In a nutshell

Emilie MBA's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

1 year(s), 10 month(s)

Emilie MBA's Willingness to Change Jobs

Unlikely

Likely

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