Manager Clinical Research

EDWARD (TED)MCKITTRICK 724-***-**** ● *********@****.****** com ● Park, LinkedIn PA

Analytical and results-focused MEDICAL clinical research DEVICE leader CLINICAL offering RESEARCH 25 years of experience PROFESSIONAL providing dynamic communication on comprehensive new technologies expertise and in therapies cardiovascular to customers research, and novel medical implantable staff in medical FDA device clinical trials, studies. training, Background sales support, includes and management. makers throughout Confidently all phases interface of clinical with cross-research. functional Strategic research planner and with site a proven teams, track study record participants of territory and management, key decision team expertise CELLAEGIS, collaboration Strategic Clinical include: Mississauga, Product Planning Research and Promotion effective • • Employee Ontario.Territory sponsor • ..Patient ..Supervision ..Management to Support .customer CAREER ..& Training .• ..Clinical .Device communications HISTORY Training .Studies .Educational ..• in .Device .Coaching all ..Programs phases ..Trials and of • ..Mentorship • .Relationship ..Technical research. Additional Support Building . 2018 to areas Present of Director of Clinical Program Management

Oversee overall program management for the ongoing SHIELD deNovo IDE US clinical study, with direct supervision of the clinical site manager. Drive the execution of the study’s operational plan inclusive of start-up, conduct, vendor oversite, and budgeting, enforcing strict adherence to all relevant regulations including GCP, ICH, and regulatory requirements. Work collaboratively with principal study investigator, site investigators, research coordinators, and contracted CRO management to ensure all deliverables are met. Interface with CellAegis CEO and management team to prepare comprehensive reports, presenting study updates and progress reports at quarterly Board meetings.

• Leverage deep clinical knowledge of Remote Ischemic Conditioning and its correlation to past and current studies to guide study specific decisions and training of physicians and healthcare professionals.

• Assumed trial management during a period of slow enrollment, retraining clinical staff and introducing new collaborative strategies for research patient identification and recruitment across 15 trial sites, effectively increasing study participation by 25-30% and reducing the overall study enrollment phase of the trial.

• Devised methods to increase response time and achievement of deliverables initiating bi-weekly staff phone calls to review site management concerns, study objectives, and milestones, enabling the company to successfully meet its first targeted deadline since the trial’s launch in 2017. ZOLL, Pittsburgh, PA 2016 to 2018 Manager of Clinical Operations – ZOLL LifeVest

Provided leadership and guidance for clinical trial execution in concert with the Vice President of Clinical Affairs, Research Scientist, and Study Project Managers. Monitored and facilitated all activities supporting the achievement of key clinical site targets including subject recruiting, study education and investigator meetings, and investigator motivational site visits as needed to maintain study momentum. Established strong clinical relationships to foster industry-wide collaboration and joint participation in ZOLL clinical research study protocols and evidence-based marketing initiatives.

• Created engaging and visually-appealing protocol reference cards for distribution during trial enrollment to generate enthusiasm and operational organization for study success and site performance.

• Proactively developed methods to boost LifeVest sales, educating physician hospitalist participating in a pilot program on techniques and strategies for early identification of potential candidates for LifeVest prescriptions, successfully increasing prescription rates across designated sites. EDWARD (Career History, (TED) continued) MCKITTRICK 724-***-**** ● *********@****.**** com 2 CARDIOKINETIX, Menlo Park, CA 2014 to 2016 Account Manager

Engage, educate, and train physicians, research coordinators, and Cath lab personnel on the protocol requirements and study objectives in the pivotal IDE Parachute IV Heart Failure clinical trial. Play an integral, hands-on role during the clinical trial implant in Cardiac Catheterization labs responsible for prepping the implantable device and proctoring Interventional Cardiologist during the implant procedure.

● Achieved recognition as the No. 1 enrolling site participating in the US clinical trial by providing investigators at Case Western University with hands-on training, intra-procedural education, and facilitation of protocol compliance.

● Managed, trained, and engaged Cardiology Heart Failure Investigators and clinical research team members assigned to the study at six participating sites across the Northeast.

● Traveled to China for two weeks in 2016 to train and support Parachute implants in emerging markets within different provinces and medical centers throughout the country. BOSTON SCIENTIFIC, St. Paul, MN 2010 to 2014 Senior Field Clinical Engineer, Eastern Territories Supported the rollout and market launch of the Subcutaneous Implantable Cardioverter Defibrillator (Sub-Q ICD) across institutions in the eastern region, training and educating sales representatives, clinical staff and technical specialist on the specifications, technology utilization, and clinical testing requirements.

● Directly support Ohio State University, the highest enrolling trial site, during surgical implantation, follow up, device troubleshooting, and data collection.

● Lead onsite interaction at sites, in conducting, monitoring, and implementing the IDE protocol for the US clinical study of the Cameron Health Sub-Q ICD system.

ST. JUDE MEDICAL CORPORATION, Sylmar, CA 2007 to 2010 Manager, Field Clinical Engineering, East Great Lakes Established a clinical research presence in the East Great Lakes Region, developing study participation sites in Pennsylvania, New York, and West Virginia. Collaborated with senior sales managers to strategize long-term goals and site partnerships.

● Recruited, hired, trained and mentored eight Field Clinical Engineers to staff clinical sites in a territory without previous clinical research participation.

● Created research partnerships with major academic institutions including the University of Rochester, UPMC, University of Pennsylvania, Drexel University and Hershey Medical Center. BOSTON SCIENTIFIC/GUIDANT, St. Paul, MN 1995 to 2007 Field Clinical Engineer, Group Leader, Cardiac Rhythm Management (CRM) Division (2000 – 20007) Supported FDA investigational device exemption (IDE) clinical device trials at designated medical centers in southern New Jersey training physicians and regional clinical engineers on device operations and new therapy methodologies. CPI/Fairfax sales and GUIDANT/Hospital marketing to BOSTON serve of implantable as SCIENTIFIC a Field Clinical pacemakers ADDITIONAL (1995 Representative to and 2000)ICD’s. PREVIOUS : Recruited on Later behalf EXPERIENCE transitioned from of Cardiac an EP to Lab Pacemakers dedicated Manager sales Inc and (roles CPI) Cath supporting and lab position ultimately the at Field Clinical Engineer following EDUCATION, CPI’s acquisition TRAINING, by Guidant. & TECHNICAL PROFICIENCIES Thomas Bachelor Edison of Arts State in Liberal College 2006 Arts TESTAMUR/NASPEExAM/Registered AP, Cardiovascular North American Invasive Society Specialist of Pacing –RCIS and Electrophysiology 1998 2001

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