Greg Voss Email & Phone Number

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

• Responsible for all domestic clinical trial design and execution of the US/Global clinical trial portfolio including clinical data summary reports(CDSR) for Europe, summary reports for Japan and PMAs for U.S. device.
• Creation of global collaborative team consisting of Japan, European and U.S. Clinical Affairs in streamlining Japan submissions, review via Shomen Chosa with PMDA and approval by MLHW (Ministry of Health, Labor and.

Marlborough, MA, US

• Responsible for all domestic clinical trial design and execution of the US/Global clinical trial portfolio including clinical data summary reports(CDSR) for Europe, summary reports for Japan and PMAs for U.S. device.
• Creation of global collaborative team consisting of Japan, European and U.S. Clinical Affairs in streamlining Japan submissions, review via Shomen Chosa with PMDA and approval by MLHW (Ministry of Health, Labor and.

Marlborough, MA, US

• Lead the management team through a process of defining the International Strategic Plan (ISP), a multi-country shared central services model of clinical execution, information systems and financial management..
• Created a combined Vascular Intervention/Cardiac Rhythm Management Clinical Operations team and implemented shared service model with successful cross-division trial support and efficiency gain.
• Managed retention and separation of the Clinical Operations team through Boston Scientific/Abbott Laboratories acquisition of Guidant.

Marlborough, MA, US

• Lead the management team through a process of defining the International Strategic Plan (ISP), a multi-country shared central services model of clinical execution, information systems and financial management..
• Created a combined Vascular Intervention/Cardiac Rhythm Management Clinical Operations team and implemented shared service model with successful cross-division trial support and efficiency gain.
• Managed retention and separation of the Clinical Operations team through Boston Scientific/Abbott Laboratories acquisition of Guidant.

• Created the organization providing strategic, tactical leadership and direction to the Clinical Research Operations internal/external team (i.e., Clinical Monitoring, Data Management and Site Support).
• Effective Management of a $7.3 million budget consisting of three cost centers to within +/- 5% of plan.
• Led and managed clinical operations team expanding the organization by 200% to approximately sixty consisting of five Group Leads/Supervisors and four teams of individual contributors.
• Clinical Monitoring- defined the vision, created the regional plan and hired the clinical field monitoring organization comprised of three supervisors and a team of twenty five monitors.
• Data Management- requested and received capital funding of ~$1M funding to implement Remote Data Entry (RDE) and lead the team to the 1st successful implementation of Remote Data Entry (RDE) in Guidant’s history.
• 1st release and implementation lead of department-wide people, process and technology re-engineering effort. Resulted in a more effective site selection method and efficient regionally organized trial contracting/IRB.

• Effective management of the data management team facilitating accurate and timely clinical trial data (CRFs, Holters, Echos, Parameters and EKGs) processing, filing and database entry.
• Through process re-engineering/metrics team established consistent data entry times of 24 hours in support of “6 hour PMA/Speed to Market” objective.
• Team member providing guidance and oversight of Contak CD Heart Failure PMA/Panel prep, Guidant’s 1st Heart Failure Device.
• Selected to support Guidant Endovascular Technologies (EVT) actions with the Abdominal Aortic Aneurysm (AAA) device, Ancure. Spent 12 weeks commuting to Menlo Park, California providing ongoing trial management support.

• Developed and wrote the Investigational Plan for bradycardia devices, pacemakers/pacemaker leads. Interfaced with core labs, investigators, field organization and biostatisticians in support of clinical trial data.
• Preparation/Writing of multiple FDA IDE annual/progress reports and PMA submissions. 1st 40 hour Clinical department PMA report.

• Managed U.S. IDE clinical trial of the Atrial Septal Defect (ASD) occluder device, “Angel Wings”. Responsibilities included: monitoring, implant/follow-up technical support, site initiation, protocol/report writing.
• Interface with National PI, Investigators/Co-Investigators, nurses and technicians to establish the safety and efficacy of device.
• Panel preparation for changes in 1:1 randomization assignment, device to surgery to 2:1.

• Member of the tachycardia clinical trial team with the responsibility of monitoring the company's implantable cardiac defibrillator clinical products which included: auditing of incoming clinical data, data analysis.
• Collect, interpret and analyze data for the submission of clinical reports to the FDA in conjunction with regulatory affairs and statisticians.
• Responsible for completeness and accuracy of data recorded on CRFs received from study investigators to insure and maintain compliance with study protocol and FDA requirements.

• Management of Interventional Cardiology Research Laboratory, technicians and GLP/GCP research protocols for Interventional Cardiology, other research laboratories and industry (SciMed and Schneider USA).
• Coordinate Engineer, develop and test per protocol following FDA GLP: septal defect closure devices, coronary angiographic catheters, effects of Nitric Oxide, CPR device, intravascular ultrasound, coronary stents.