Andrew Habbe
Indianapolis,IN
Overview
16
16
years of professional experience
Work History
Senior Project Manager
Thermo Fisher Scientific
Morrisville, NC
07.2021 - Current
- Company Overview: On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD
- As a Project Lead, serves as the primary contact between the sponsor and PPD at the project level; drives and owns the overall delivery of the contracted project through cross-functional project leadership and ensuring clear delineation in responsibilities and communication pathways for secondary project leads when applicable; ensures project-level financial stewardship by understanding the contract, resource alignment to budget, management of OOS, negotiating and driving the contract modification process; drives and owns the risk mitigation process; and establishes, communicates and manages customer expectations to achieve optimal delivery
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD
Senior Clinical Team Manager
Thermo Fisher Scientific
Morrisville, NC
04.2020 - 07.2021
- Company Overview: On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD
- As a Global Clinical Team Manager, directs and takes ownership of project clinical deliverables at a global level while leading team of regional CTMs to drive and achieve consistency and operational delivery
- Leadership in the development of the monitoring strategy at a project level accounting for potential risks and bringing solutions when issues arise
- Furthermore, utilizing tools and data sources to proactively identify emerging risks and mitigating them prior to becoming issues
- Collaborates with the Project Lead, Project Functional leads and other stakeholders to prepare, organize and present during internal or external meetings
- As well as develops functional project plans and tools including appropriate system set-up as needed
- Departmental financial responsibility for forecasting and reconciliation of clinical budget in accordance with scope, proactively identifying and partnering with Project Lead and sponsor to address any out-of-scope tasks
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD
Clinical Team Manager
Thermo Fisher Scientific
Morrisville, NC
09.2015 - 04.2020
- Company Overview: On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD
- As a Clinical Team Manager, drive and own the clinical deliverables at a project level ensuring timelines, resources and quality are maintained and adequate activities
- Providing team support and project-specific training, leadership and therapeutic knowledge to the clinical team to achieve project goals and maintain motivation
- Lead the development of the monitoring strategy at a project level accounting for potential risks and bringing solutions when issues arise
- Departmental financial responsibility for forecasting and reconciliation of clinical budget in accordance with scope, proactively identifying and partnering with Project Lead and sponsor to address any out-of-scope tasks
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD
Clinical Trial Associate III
Endocyte, Inc.
Indianapolis, IN
12.2013 - 08.2015
- Managed and coordinated clinical operations of trials and collaborated across all functional departments to ensure project timelines were met and within budget
- Responsible for the coordination and development of study documents (including Protocol, ICF, Monitoring Plan, Risk Management Plan, Safety Management Plan, Pharmacy Manual, etc.) as well as other study tools and templates
- Contributed to the RFP process and participated in CRO and other vendor selection
- Managed and coordinated CRO and other vendor activities in accordance with service agreements
- Served as primary point of contact for sites, vendors, and CROs
- Managed CRAs on the conducted of site initiation, routine monitoring, and closeout monitoring visits and completed all level of visits as necessary
- Provided training and oversight to study team members for study deliverables
Clinical Trial Associate II
Endocyte, Inc.
Indianapolis, IN
05.2011 - 12.2013
- Managed and coordinated all aspects of the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with GCP/ICH guidelines and other regulatory requirements
- Responsible for the implementation and management of projects and assisted in the development of relevant study and clinical documents
- Responsible for the execution of study and site monitoring which included monitoring and co-monitoring of all site visit types
- CTMS system manager for assigned studies
- Including the superuser and system administrator role wherein the responsibilities included maintaining, reconciling, report development, and training for new users
Clinical Trial Associate I
Endocyte, Inc.
Indianapolis, IN
11.2008 - 05.2011
- Contributed to day-to-day operations of the Clinical Affairs department and supported project teams related to study management from Start-up to Close-out
- Setup and maintained tracking systems and tool, and report study metrics to management
- Served as primary site contact to resolve issues, questions, and request
Timeline
Senior Project Manager
Thermo Fisher Scientific
07.2021 - Current
Senior Clinical Team Manager
Thermo Fisher Scientific
04.2020 - 07.2021
Clinical Team Manager
Thermo Fisher Scientific
09.2015 - 04.2020
Clinical Trial Associate III
Endocyte, Inc.
12.2013 - 08.2015
Clinical Trial Associate II
Endocyte, Inc.
05.2011 - 12.2013
Clinical Trial Associate I
Endocyte, Inc.
11.2008 - 05.2011