Averiel Mangarelli
NJ
Summary
Dynamic Project Manager with a proven track record at TFS HealthScience, excelling in budget management and regulatory compliance. Adept at fostering client relationships and leading cross-functional teams. Skilled in Microsoft Office 365 and renowned for exceptional communication and organizational abilities, ensuring timely project delivery and adherence to quality standards.
Overview
16
16
years of professional experience
Work History
Project Manager
TFS HealthScience | NJ
10.2022 - Current
- Ensure that projects are delivered on-time, within scope and within budget and in compliance with applicable quality standards
- Budget set-up, budget review, invoicing, tracking of change(s) in scope and Pass-Through Costs as appropriate
- Delivers projects on-time, within scope and within budget and in compliance with applicable quality standards
- Supports the (Senior) Project Director/ Project Director in Management of the projects in accordance with company policies, SOPs, Wis, regulatory requirements, in addition to financial and contractual obligations
- Communicates with clients to successfully manage the relationship, timelines, and financials
- Maintains sound business practices and actively contributes to the organization and development of processes
- Review of Protocol Deviations with the medical monitoring teams
- Development and maintenance of Project Plans and timelines for the project as well as track progression
- Develops and maintains other steering documents such as Monitoring Plan
- Ensuring – together with the study team – that Study Master File is being initiated, maintained and closed/archived
- Set-up and maintenance of study information in the Clinical Trial Management System as per delegation from the PM /CRA(s)
- Vendor Management and coordination with Study Supplies and assists in study reporting
- Ensures arrangement of internal and external meetings
- Assists in activities associated with audits and inspections
- Supports the study team in all regulatory processes (IEC/IRBs/CA) including submission of initial application and amendments
- Assists the study team in management of contracts such as site agreements, pharmacy agreements
- Manages Investigator Payments as delegated by CRA(s)
Associate Project Manager
TFS HealthScience
, NJ
03.2020 - 10.2022
Sr. Clinical Trial Associate
IQVIA Biotech | NJ
12.2018 - 03.2020
- Oversee clinical supplies and distribution to sites
- Communicate with sites on issues escalation related to clinical supplies
- Prepare, collect and provide support to sites on essential document collection and maintenance
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper)
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File
- Prepare and submit central IRB submissions and communicate with the IRB
- Provide support to sites for site and local IRB submissions
- Assist Clinical Trial Manager (CTM) with development of Informed Consent Form Template (ICF)
- Manages client meetings, status of studies, and maintain minutes/ agenda
- Coordinate with Recruitment Management regarding advertising submissions to IRB
- Prepare Drug Release Authorization forms and collect required documentation
- Develop, data enter, and maintenance of study tracking databases/logs (i.e
- Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit
- Reports, confirmation/follow-up letters in TMF
- Assist CTM with tracking of clinical trial agreements (CTA) with Investigator Sites
- Prepare and coordinate materials (e.g
- Binders, agendas, meeting minutes, slide presentations) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face
- Meetings (FTF)
- Perform data entry into electronic systems (i.e
- CTMS) for study or client information
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
- Communicate with sites on issues escalated by a monitor and/or the CRA Manager
- Train entry level personnel Clinical Trial Associate (CTA) I and/or Project Assistant (PA)
- Perform administrative tasks to support team members with clinical trial execution as needed
Sr. Clinical Trial Associate
Novella Clinical | NJ
09.2017 - 12.2018
- Oversee clinical supplies and distribution to sites
- Communicate with sites on issues escalation related to clinical supplies
- Prepare, collect and provide support to sites on essential document collection and maintenance
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper)
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File
- Prepare and submit central IRB submissions and communicate with the IRB
- Provide support to sites for site and local IRB submissions
- Assist Clinical Trial Manager (CTM) with development of Informed Consent Form Template (ICF)
- Coordinate with Recruitment Management regarding advertising submissions to IRB
- Prepare Drug Release Authorization forms and collect required documentation
- Develop, data enter, and maintenance of study tracking databases/logs (i.e
- Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit
- Reports, confirmation/follow-up letters in TMF
- Assist CTM with tracking of clinical trial agreements (CTA) with Investigator Sites
- Prepare and coordinate materials (e.g
- Binders, agendas, meeting minutes, slide presentations) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face
- Meetings (FTF)
- Perform data entry into electronic systems (i.e
- CTMS) for study or client information
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
- Communicate with sites on issues escalated by a monitor and/or the CRA Manager
- Train entry level personnel Clinical Trial Associate (CTA) I and/or Project Assistant (PA)
- Perform administrative tasks to support team members with clinical trial execution as needed
Clinical Trial Associate II
Novella Clinical, NJ
06.2017 - 09.2017
Clinical Trial Associate I
12.2016 - 06.2017
- Oversee clinical supplies and distribution to sites
- Communicate with sites on issues escalation related to clinical supplies
- Prepare, collect and provide support to sites on essential document collection and maintenance
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper)
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File
- Prepare and submit central IRB submissions and communicate with the IRB
- Provide support to sites for site and local IRB submissions
- Assist Clinical Trial Manager (CTM) with development of Informed Consent Form
- Template (ICF)
- Coordinate with Recruitment Management regarding advertising submissions to IRB
- Prepare Drug Release Authorization forms and collect required documentation
- Develop, data enter, and maintenance of study tracking databases/logs (i.e
- Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit
- Reports, confirmation/follow-up letters in TMF
- Assist CTM with tracking of clinical trial agreements (CTA) with Investigator Sites
- Prepare and coordinate materials (eg, binders, agendas, meeting minutes, slide presentations) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF)
- Performs data entry into electronic systems (i.e.CTMS) for study or client information
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
- Communicates with sites on issues escalated by a monitor and/or the CRA Manager
- Train entry level personnel Clinical Trial Associate (CTA) I and/or Project Assistant (PA)
- Perform administrative tasks to support team members with clinical trial execution as needed
Clinical Trial Associate
TKL Research Inc
, NJ
03.2015 - 12.2016
- Prepares, reviews and approves all regulatory documents and communicates with project teams, clients, outside sites, vendors, etc.)
- Prepares regulatory submissions and communicates with the vendor in regards submissions/approvals; maintains an organized Master File
- Leads status calls and prepares weekly meetings, status reports, and teleconferences
- Tracks all enrollment activities (updates Logs weekly)
- Assists in the preparation of newsletters and important updates, in addition supplies team members with all necessary items needed in order to execute the study flawlessly
- Assists Project Management Team with all important tasks.
Account Coordinator
Ogilvy CommonHealth, Team Chemistry | NJ
10.2012 - 03.2015
- Managed multiple meeting materials from conception to FDA submission adhering to client-specific compliance and regulatory guidelines throughout production while overseeing project timelines to ensure project delivery within budget
- Led status calls and prepared weekly meetings, status reports, teleconferences and web-ex
- Followed up on any necessary documents that needed to be route through the company
- Served as liaison between client, account management, editorial, and creative in executing content development ensuring the incorporation of revisions during mechanical stages to FDA submission for approval
- Provided administrative support to assigned team members and proactively assist Account Executives in developing and formatting faculty and recruitment grids while documenting responses and completion of HCC exclusion checks
- Monitored budgets by running job reports regularly for client tracking and project’s financial information for status reports to include budgeted and actual fee and OOPs to-date, monthly % complete, change of scope(s) status, grantor PO # and invoicing information when appropriate and necessary; Identify potential problems, notify team members of issues, and suggest possible solutions.
Speakers Bureau Assistant/Financial Reconciliation
KnowledgePoint 360 Group, Physicians World
05.2009 - 05.2012
- Ensured a high volume of HCP honoraria and expense checks met all requirements
- Verified all HCP honoraria and expense checks against HCP Consulting Services Agreements prior to releasing payments
- Uploaded HCP W-9 information into proprietary software system as well as verified all information on forms.
Senior
- In Management of the projects in accordance with company policies, SOPs, regulatory requirements, in addition to financial and contractual obligations
- Communicates with clients to successfully manage the relationship
- Maintains sound business practices and actively contributes to the organization and development of processes
- Supports PM in delivery of projects on-time, within scope and within budget and in compliance with applicable quality standards
- Budget set-up, budget review, invoicing, tracking of change(s) in scope and Pass-Through Costs as appropriate
- Oversee Project Associates and/or Clinical Trial Assistants assigned to different projects and/or across programs, ensuring project specific deliverables completed on time or ahead of schedule, as required
- Development and maintenance of Project Plans and timelines for their project and track progress
- Support the PM in development and maintenance of other steering documents such as
- Monitoring Plan
- Ensuring – together with the study team – that Study Master File is being initiated, maintained and closed/archived
- Set-up and maintenance of study information in the Clinical Trial Management System as per delegation from the PM /CRA(s)
- Coordinates Study Supplies and assists in study reporting
- Ensures arrangement of internal and external meetings
- Assists in activities associated with audits and inspections
- Supports the study team in all regulatory processes (IEC/IRBs/CA) including submission of initial application and amendments
- Assists the study team in management of contracts such as site agreements, pharmacy agreements
- Manages Investigator Payments as delegated by PM/CRA(s)
Education
NJ Licensed Aesthetician -
Artistic Academy
Morris Plains, NJ02.2005
High School -
Nutley High School
01.2004
Skills
- Skilled in Microsoft Office 365
- Content Publisher
- Advanced Excel Proficiency
- Experienced with Word
- Knowledgeable in Multiple IRB Submission Systems
- ETMF experience
- Experienced in Veeva Vault
- Client relationship management
- Wingspan
- SharePoint
- Skilled in multi-purpose portals
- Excellent communication skills
- Customer service skills
- Highly organized
- Efficient Task Management
- Strong managerial skills
- Displays professionalism
- Vendor coordination
- Regulatory compliance
- Clinical trial oversight
- Budget & Project management
Timeline
Project Manager
TFS HealthScience | NJ
10.2022 - Current
Associate Project Manager
TFS HealthScience
03.2020 - 10.2022
Sr. Clinical Trial Associate
IQVIA Biotech | NJ
12.2018 - 03.2020
Sr. Clinical Trial Associate
Novella Clinical | NJ
09.2017 - 12.2018
Clinical Trial Associate II
Novella Clinical, NJ
06.2017 - 09.2017
Clinical Trial Associate I
12.2016 - 06.2017
Clinical Trial Associate
TKL Research Inc
03.2015 - 12.2016
Account Coordinator
Ogilvy CommonHealth, Team Chemistry | NJ
10.2012 - 03.2015
Speakers Bureau Assistant/Financial Reconciliation
KnowledgePoint 360 Group, Physicians World
05.2009 - 05.2012
Senior
NJ Licensed Aesthetician -
Artistic Academy
High School -
Nutley High School