Mark Gundersen

Results-oriented Program Manager with 14 years of experience in leading complex projects within Clinical Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) offering history of success coordinating and monitoring operations across various departments. Highly committed with hardworking mentality to maintain quality of services and products. Proven track record of delivering projects on time, within budget, and in compliance with industry regulations. Skilled in cross-functional team leadership, stakeholder management, and strategic planning. Adept at driving continuous improvement initiatives to enhance operational efficiency and client satisfaction.

Program Manager:

Responsible for leading and delivering complex projects within diverse industries, ensuring compliance within GDP and FDA guidelines. Skilled in strategic planning, resource allocation, and stakeholder management to ensure project alignment with organizational objectives. Adept at fostering collaboration, driving innovation, and delivering results in fast-paced environments. Strong communicator with excellent leadership abilities and a commitment to continuous improvement.

Associate Project Manager / Project Manager: 

Provides overall leadership of EP clinical trials, ensuring the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy. Also being accountable for the successful delivery of projects/programs (on time, on budget, and to the highest quality) compliant with ICH, GCP, and other applicable documents and regulations. Fully understands and ensures compliance with relevant SOPs, contract terms, system requirements and metrics. Oversees Project Assistants to assure development of the project plan, team lists, maintenance of central files/regulatory files/investigator site file, maintenance of training records, and generation of metrics reports. 

Clinical Research Coordinator: 

A responsible and organized CRC, who executes and coordinates a variety of specialized clinical research activities, including both Phase 1 and 2a studies, ensuring that established protocols are implemented and followed. Supervises and manages study team members. Monitors patient status and safety. Collects and organizes research data and assists in preparation of regulatory documents (IRB submission and informed consent). Schedules project specific training and unit in-services to train staff on protocols, GCP guidelines, treatments and possible side effects and complications. Collects and organizes research data. Educates patients and their families about treatments and potential side effects. 

Enrollment Specialist I: 

An organized Enrollment Specialist, who executes and coordinates the enrollment process of clinical research studies including all activities from recruitment to admission. Gives helpful feedback for enrollment feasibilities and marketing strategies. Ensures that protocols are implemented and followed according to Good Clinical Practice (ICH GCP). Collects and organizes research data in an orderly fashion. Educates participants about treatments and possible side effects and complications. Stays in constant contact with Study Team regarding enrollment timelines and recruitment results. Assesses and monitors patient status and safety. Institutes emergency procedures as necessary. Enrolment Coordinator: An organized Enrollment Coordinator, who executes and coordinates the enrollment process of clinical research studies including all activities from recruitment to admission. Ensures that protocols are implemented and followed according to Good Clinical Practice (ICH GCP). Collects and organizes research data. Educates participants about treatments and possible side effects and complications. Assesses and monitors patient status and safety. Institutes emergency procedures as necessary. 

Research Technician: 

A responsible research technician, working morning, evening, and night shifts when study-specific tasks were needed to be carried through. Familiar with phlebotomy skills, vital sign procedures, as well as performing under strict time constraints. Provides clinic support for Clinical Pharmacology Studies under supervision in accordance with agreed protocols and the principles of International Conference on Harmonisation Good Clinical Practice (ICH GCP). 

Laboratory Technician: 

A diligent and meticulous laboratory technician, who dedicated mornings, evenings, and nights to correctly process and store blood and urine samples for further study-specific analysis. Experienced in handling, storing, and shipping hazardous and biological materials samples intended for clinical pathology, pharmacokinetic or pharmacodynamic investigations. Provides laboratory support for Clinical Pharmacology Studies under supervision in accordance with agreed protocols and the principles of International Conference on Harmonisation Good Clinical Practice (ICH GCP).