Michael Mccane Email & Phone Number

• Oversee full project management of external client clinical trial projects from feasibility, budget, and contract negotiations to execution.
• Leading key stakeholder business operations committee with a focus on increasing efficiency in the execution of the organization’s projects.
• Designed and lead the implementation of new clinical trial management software features to optimize efficiency for the Contract Research Organization department.
• Lead and managed the first sponsor industry COVID-19 pharmaceutical trial for the UTSW Contract Research Organization.

Abbott Park, Illinois, US

• Managed customer experience discrepancies directed towards the organization’s approved medical products.
• Managed team initiative in a global recall and consolidation project for the company’s deep brain stimulation products.

Morrisville, NC, US

• Managed and coordinated the company’s clinical trial projects and increased local awareness and patient enrollment by more than 50%.
• Coordinated the protection of the customers by adhering to the requirements established by the external clients.
• Monitored study operations independently in a remote, and clinical fast pace environment with minimal supervision
• Collected blood samples, tracking shipments, keeping inventory and requesting study supplies as needed.

Southlake, Texas, US

• Project Lead – Identified and screened subjects for eligibility in participation using protocol specific inclusion and exclusion criteria.
• Main point of contact between TDDC, sponsor, CRO, research participants, Director and PI for each respective study.
• Coordinated regulatory, compliance and monitoring efforts with IRB, sponsor, and CRO regarding the access, use, and disclosure of PHI, and report instances of noncompliance to the appropriate compliance office.
• Consented and assisted in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Completed study documentation and maintenance of study files in accordance with sponsor requirements including, consent forms, source documentation, narrative notes, case report forms, and investigational material.
• Managed department Clinical Study Workflow Chart and entered all subject data per visit in various e-CRF and Clinical Trial Management Systems.

Plano, Texas, US

• Performed In-House Strategy Development with C-Suite and Senior Management [3 Months / 12 Weeks]
• Identified and presented new market entry and vertical growth opportunities for Accelerated Clinical Trials (ACT) Department. Organized business development pitch and internal cost analysis (Execution team, revenue.
• Performed competitive landscape analysis for over 350 domestic and international pharmaceutical, biotechnology, and medical device companies and consulting firms.
• Organized US and Ex-US Sponsor Investigator Meeting accrual sessions for Fortune 100 and Global Fortune 200 Companies.
• Appointed project operations liaison with sponsor Project Manager, and CRO Project Manager.
• Self managed and coordinated KOL recruitment analytics, project logistics, and closeout reporting.

Arlington, Virginia, US

• Commandeered healthcare and clinical operations for the Charlie Company Medical Division and 4-9 Infantry Medical Platoon during Operation Iraqi Freedom. Stationed in greater US (4x), Iraq, Singapore, and Kuwait.
• Combat medic (68W-10 MOS) and EMT Instructor for Operation Iraqi Freedom. Ranked top 1% amongst ~7000 EMT/Combat Medics in 4th Brigade, 2nd Infantry Division for emergency preparedness and clinical competency.
• Selected and recognized for outstanding EMS performance during Operation Lightning Strike, a military partnership with Singapore Armed Forces. Operations lead for EMS education and training and received PACOM Award for.
• Honors: PACOM Award, Army Achievement Medal, Army Commendation Medal, Army Iraq Campaign Medal, Army Good Conduct Medal. Honorably discharged February 2012.