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<pre>Array ( [var] => cut_url ) </pre> Resume for Michael M. for Project Manager / Biotechnology & Pharmaceuticals in Lincoln, Nebraska. Search More Resumes for Project Manager on #9LMWMK4B9

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Resume for Michael M. for Project Manager / Biotechnology & Pharmaceuticals in Lincoln, Nebraska

Occupation: Project Manager Industry: Biotechnology & Pharmaceuticals
Country: United States City: Lincoln
State: Nebraska ZIP: 68516

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Michael T. M.

Locust Street

Lincoln, NE 

..  .. 


An experienced clinical research professional with extensive Phase IIV exposure.  Broad knowledge of the drug development process.  Recognized as a goal driven manager with exceptional critical thinking abilities.  Key strengths in leadership, team building, strategic management, marketing and problem resolution.

Expertise includes

  • Supervisory and operational management.
  • Clinical Project Management.
  • Clinical Research Coordination.
  • Network and market development.
  • Strong knowledge of CFR, GCP and ICH.
  • Solid CRO experience.

    Quintiles, Research Triangle Park, NC 

    Clinical Research Coordinator

    Developed market for clinical research partner program. Identified appropriate medical facilities, performed directed market research, developed marketing strategies, and identified key decision makers. Sold clinical research partner program, providing technical and regulatory support while bridging institutional bureaucracies. Ensured contract execution. Developed research program in partner sites. Performed capabilities assessments and ensured trial placements. Recruited and coordinated clinical trials at partner sites requesting research support.

  • Recruited three medical sites as partners in a highly competitive and closely guarded market.
  • Built research program from the ground up for a busy internal medicine practice.
  • Successfully placed trials in one year at a research naive site.
  • Selected to participate in employee engagement committee.
  • Provided indepth analysis and detailed reports for global clinical research issues.
  • Coached and supported other remotely based employees.
  • Utilized in depth knowledge of GCP / CFR / ICH to ensure proper clinical study execution.

    Qualia Clinical Services, Omaha, NE 

    Clinical Study Manager / Recruiting Manager

    Hired and led a team of direct reports. Provided project and operational management by developing project specific timelines, benchmarks, logistics, protocol generation support, case report form generation, informed consent form generation, source document generation and contract support. Coordinated kick off meetings, monitored metrics, managed interdisciplinary team, monitored logistics, provided interim data analysis and reporting, supervised and managed clinical conduct of research projects. Developed and wrote SOPs. Performed workflow analysis, established metrics, and conducted ongoing workflow study and modifications to meet metrics.

  • Managed over Phase I / II trials.
  • Brought recruiting team into corporate compliance within days by performing workflow analysis and establishing metrics.
  • Turned around team morale, establishing a supportive and effective team environment.

    Michael T. M. Page Two 

    Qualia Clinical Services Continued

  • Developed stepbystep plan for study conduct.
  • Trained all clinical staff on study specifics.
  • Reviewed and approved CRFs.
  • Reviewed and made necessary revisions to any internally developed protocols.
  • Assisted in the conduct of the clinical trial to shore up any personnel shortages.
  • Utilized in depth knowledge of GCP / CFR / ICH to ensure proper clinical study execution.

    Alegent Health Systems, Omaha, NE 

    Clinical Research Coordinator

    Coordinated surgical and endocrine inpatient studies.

  • Provided research coordination for surgical and endocrine inpatient phase III and IV trials.
  • Utilized in depth knowledge of GCP / CFR / ICH to ensure proper clinical study execution.

    MDS Pharma Services, Lincoln, NE   –

    Research Assistant Team Lead

    Provided leadership and supervision for a team of associates in a very busy Phase I clinic utilizing a matrix management model. Ensured all SOP's and protocol specifics were met. Provided education and training. Managed all sample processing, logistics, staffing, and compliance issues. Generated daily staffing and clinical conduct reports.

  • Developed and implemented a program which saved department over $M in through innovative reorganization of query resolution system.
  • Monitored adherence to the company’s high standards and compliance with FDA regulations.
  • Selected as crossfunctional decisionmaking interface with Information Systems, Human Resources and management team.
  • Improved departmental efficiency by % through innovation and positive leadership.
  • Improved research processes by developing and leading focus groups.
  • Utilized in depth knowledge of GCP / CFR / ICH to ensure proper clinical study execution.

    Bryan LGH Medical Center, Lincoln, NE  –

    Advanced Clinical Technician / Paramedic

    Provided life saving care utilizing the paramedic scope of practice under the direct supervision of an MD. Worked in a busy Level Trauma Center. Provided support in surgical, cathlab, radiology, and burn departments.

  • Successfully served as part of the medical team in a trauma center.
  • Used critical thinking skills and problem solving in a fastpaced, stressful environment.
  • Provided excellent patient care by anticipating and responding to needs.

    Rural Metro Ambulance, Lincoln, NE  –


    Provided paramedic scope of practice care to the community.

  • Cared for injured and sick patients in a busy system.
  • Recognized for strong leadership and technical skills.
  • Necessitated critical thinking skills and problem solving in a fast paced, stressful environment.
  • Provided all aspects of emergency scene management to ensure patient care.
  • Ensured seamless patient care by coordinating the resources necessary for a successful rescue.


    Michael T. M. Page Three 


    MBA, Concentration: Management, American Intercontinental University, Hoffman Estates, IL

    BA, History, Southwest State University, Marshall, MN

    Paramedic Certification, Honor Graduate, Trinity College of Allied Health, Moline, IL 

    Honors / Activities / Community Involvement  

    Invited to lead marketing efforts for a local nonprofit

    Member United States Fencing Association

    Member MBAA

    Recipient of peer nominated award for excellence

    Letter of Commendation for actions above and beyond the call of duty

    Undergraduate Football Scholarship

    National Model United Nations Delegate

    Current Basic Life Support Certification

    Company Certified Trainer / Mentor MDSPS

    Numerous peer recognition awards at Quintiles

    Two bronze medals at Cornhusker State Games:  Fencing

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