Renae Greene
Apex,USA
Summary
Talented professional brings proven abilities in end-to-end project management. Expert in identifying and mitigating risks, reaching milestones, and managing deliverables. Highly organized leader with great attention to detail. Forward-thinking professional with deep understanding of resolving customer problems with efficiency and civility.
Overview
31
31
years of professional experience
Work History
Senior Project Manager/Global Project Manager
Worldwide Clinical Trials
04.2022 - Current
- Act as key sponsor contact for assigned projects
- Responsible for the overall coordination and management of clinical trials from start up through close out activities
- Lead core project team and facilitate their ability to lead extended/complete project team
- Lead cross unit coordination both internal and external, inclusive of sub-contractors
- Define and manage project resource needs and establish contingency plans for key resources
- Ensure successful design, implementation, tracking and revision of project plans for assigned projects
- Promote effective teamwork among project team members
- Resolve conflicts as needed
- Ensure appropriate communication on project-related matters with the PM Management
- Meet financial performance targets for the assigned clinical projects
- Ensure project deliverables are met according to both WCT and client expectations
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
- Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence
- Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs established for clinical research.
Project Manager II
ICON (Legacy PRA Health Sciences)
Raleigh, NC
02.2019 - 04.2022
- Primary point of contact with sponsors and study team members
- Monitored and ensured adherence to the contractual agreement (time, scope, cost, and deliverables)
- Lead and directed cross-functional team leaders and third parties/vendors
- Fostered relationships with vendors to promote positive working relationships
- Guided and supported team leads in prioritizing, trouble-shooting and contingency planning
- Maintained open communication by presenting regular updates on project status to sponsors and study team
- Proactively identified, resolved mitigated and escalated risks and/or issues
- Collaborated with team to development, maintenance, and approval of project plans
- Chaired and lead sponsor and internal meetings
- Planned, prepared content, presented and facilitated Investigator Meetings (face to face and virtual)
- Participated in Mentor program to assist new team members.
Project Manager II
Syneos Health
Morrisville, NC
05.2012 - 06.2014
- Project Lead on Global studies
- Primary point of contact for sponsor and study team members
- Initiated projects, managed costs, and monitored performance through study closure
- Monitored enrollment, KPIs, risks and issues
- Managed study timelines
- Fostered relationships with vendors to promote positive working relationships
- Assisted direct reports with career progression and annual performance evaluations.
Project Manager
Syneos Health
Morrisville, NC
02.2008 - 04.2012
- Project Lead
- Primary point of contact to sponsor and study team members
- Initiated projects, managed costs, and monitored performance
- Monitored enrollment, KPIs, risks and issues
- Managed study timelines
- Fostered relationships with vendors to promote positive working relationships
- Assisted direct reports with career progression and annual performance evaluations.
Clinical Team Manager
Syneos Health
Morrisville, NC
10.2006 - 01.2008
- Managed operational team deliverable to sponsors, including the management of study timelines and ensuring adherence to the contracted scope of services
- Developed and conducted study specific project team training
- Managed the development of study start-up documents, project plans and study tools
- Coordinated site management activities
- Assisted direct reports with career progression and annual performance evaluations.
Senior Clinical Research Associate
Syneos Health
Morrisville, NC
12.2005 - 10.2006
- Monitored Phase I-IV clinical trials in a broad spectrum of therapeutic indications
- Primarily responsible for site management activities and performance
- Site management activities include all in-house and on-site monitoring for all visit type's in accordance with study timelines and budgets
- Assured adherence to Good Clinical Practice; investigator integrity and compliance with all study protocols
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Conducted pre-study, initiation, interim and closeout visits to verify study procedures, regulatory documents, and data completion
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results
- Mentored and trained employees new to the study and/or company
- Reviewed trip reports and letters.
Senior Clinical Research Associate
Paragon Biomedical
Irvine, CA
09.2001 - 12.2005
- Implemented electronic capturing systems to adhere with clinical research guidelines
- Collected data and followed research protocols, operations manuals, and case report form guidance
- Worked with principal investigators and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Associate
PPD Development
Morrisville, NC
03.1999 - 09.2001
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data integrity
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
Respiratory Therapist
Wake Medical Center
Raleigh, NC
05.1993 - 03.1999
- Responsible for airway management of patients in the Adult and Pediatric emergency rooms, critical care units and floors (primary focus on pediatric and neonatal care)
- Participated in the development and launch of first Pediatric Asthma Program
- Created, reviewed, and approved pediatric standard policies.
Senior Project Manager
Syneos Health
Morrisville, NC
07.2014
- Project Lead on Global studies
- Implemented and directed full-service clinical studies
- Monitored enrollment, KPIs, risks and issues
- Managed overall finances including invoicing, forecasting, revenue recognition, changes in scope and regular review /reporting of financial health
- Ensured all internal and external quality standards, SOPs, GCPs, and ICH guidelines were maintained in accordance with all local, state, and federal regulations
- Liaised with functional leads and managed vendors
- Managed the development of study documents, project plans and study tools
- Managed study and operational team communication to ensure cost efficiencies, study goals and objectives are met
- Responsible for the management of operational team deliverables to customers, including the management of study timelines and ensuring adherence to the contracted scope of services
- Assisted direct reports with career progression and annual performance evaluations.
Education
Bachelor of Science - Respiratory Therapy
Indiana University of Pennsylvania
Indiana, Pennsylvania05.1993
Skills
- Client Relationship Management
- Project Planning
- Cost Control
- Meeting facilitation
- Scope Management
- Project goals and milestones
- KPI Tracking
- Quality Control
Therapeuticareas
- Metabolic
- Hepatology
- Rare
- Central Nervous System
- Infectious Disease
- Cardiovascular
- Respiratory/Pulmonary
Phases
- I
- II
- III
Licensurecertification
- 2006, Certified CRA (ACRP Certification)
- 1996, Pediatric/Neonatal Specialist-Respiratory (NBRC)
- 1994, Registered Respiratory Therapist (NBRC)
Languages
English, Native
Timeline
Senior Project Manager/Global Project Manager
Worldwide Clinical Trials
04.2022 - Current
Project Manager II
ICON (Legacy PRA Health Sciences)
02.2019 - 04.2022
Senior Project Manager
Syneos Health
07.2014
Project Manager II
Syneos Health
05.2012 - 06.2014
Project Manager
Syneos Health
02.2008 - 04.2012
Clinical Team Manager
Syneos Health
10.2006 - 01.2008
Senior Clinical Research Associate
Syneos Health
12.2005 - 10.2006
Senior Clinical Research Associate
Paragon Biomedical
09.2001 - 12.2005
Clinical Research Associate
PPD Development
03.1999 - 09.2001
Respiratory Therapist
Wake Medical Center
05.1993 - 03.1999
Bachelor of Science - Respiratory Therapy
Indiana University of Pennsylvania
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