Mark Marchan

Experience

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  Xomed-Treace, Inc.

  Jul 1991 - Feb 1993

  Project Engineer

  Product development role designing ENT implants and developing new medical procedures and devices for otologic and nasal endoscopy.

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  Olympus Corporation of the Americas

  Mar 1993 - May 1997

  Product Manager

  Technical product manager role overseeing the development and technical marketing of gynecology and general surgery product lines, managing KOL groups, coordinating activities among Germany and Japan R&D and manufacturing teams, developing instructional materials, evaluating market opportunities, training sales staff, supervising user evaluations, and securing regulatory clearance for new products and procedures.Highlights:• Improved communication and development processes with offshore manufacturing subsidiaries, resulting in a 40% reduction in product development lead times to 9 months.• Successfully managed a joint development venture between Olympus America, Inc. and Ethicon Endosurgery, coordinating activities between management teams, off-shore development resources, and key customers, to develop a 3mm system to establish an office laparoscopy market.• Directly responsible for 50% of all new medical product line introductions at Olympus America from 1996 - 1997.• Prepared 21% of all Olympus America regulatory 510(k) submissions from 1994 – 1996. Show less

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  Walter Lorenz Surgical

  May 1997 - Nov 1999

  LactoSorb Product Manager

  Product management role overseeing the introduction and development of resorbable technology in the craniofacial market, managing key opinion leader groups, conducting market research, expanding market presence through marketing and training programs, coordinating production planning, and managing remote product development teams.Highlights:• Within three months, implemented forecasting and inventory management processes that not only eliminated persistent backorders affecting 20% of the product line but also established minimum safety stock levels preventing future backorders.• Implemented targeted marketing campaigns and established sales and customer training programs, resulting in an average annual revenue growth of 40%.• Through applied upstream marketing and market analysis, successfully achieved product line expansion of resorbable technology into five additional market segments representing $5M incremental sales for 25% growth.• Maintained active product line development, increasing new product development portfolio by 140%. Show less

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  Medtronic

  Feb 2000 - Jun 2007

  Leadership role, managing the Data Management department, optimizing processes for regulatory and post-market clinical trials in collaboration with cross-functional teams, overseeing the department budget, and ensuring regulatory compliance.Highlights:• Developed cross-functional business processes and metrics to define key customer attributes, optimize customer engagements, and maximize internal business benefits while enforcing AdvaMed and corporate integrity compliance.• Established SDVLC processes for documentation and validation of clinical research software solutions.• Designed and developed proprietary, HIPAA compliant, internet-based clinical data management platforms providing electronic data collection (EDC) tools for multi-site data aggregation and analysis, representing a potential 43% operating cost reduction of $2.8M over two years. Show less Management role facilitating cervical spine therapy advancement through research, education, key opinion leader management, third-party resource coordination, and educational initiative development while effectively expanding market presence while overseeing the annual strategic project budget to expand market presence.Highlights:• Led the in-house development of a proprietary EDC system, beating vendor-estimated timelines by 60% and cost projections by 90%.• Established an external incentive and monitoring program that improved clinical data collection activities by 193% with increased data quality of 20% across seven research sites.• Implemented internal business processes and metrics reports that reduced clinical trial study build-out lead times by 25% and reduced data discrepancies by 68%.• Successfully established a 501(c)3 non-profit organization consisting of key opinion leaders to provide education and research vehicles for shaping market direction, identifying potential opportunities, and defining customer trends.• Developed and introduced educational vehicles, such as resident training programs and textbooks, establishing channels for accessing young and upcoming surgeons and increasing market presence.• Managed the logistics supporting the introduction of artificial cervical disc replacement procedures into the international market. Show less

  • Clinical Data Director

    Jun 2005 - Jun 2007

  • Director, Strategic Projects

    Feb 2000 - Jun 2005
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  PPD

  Jul 2008 - Jul 2023

  Leadership role overseeing the Systems Innovation and Support team, managing the development, administration, and maintenance of Pharmacovigilance (PV) systems, ensuring compliance with global regulatory requirements, handling functional service provider contracts, supporting business development through RFP/RFI generation and budget estimates, establishing Business Continuity Plans (BCP) for PV systems, and providing audit support for operational excellence and regulatory compliance.Highlights:• Grew the System Innovation and Support team by 450%, expanded its presence to seven countries, and extended technical support coverage to a 22-hour day.• Expanded a proprietary Business Process Management application to include support for five additional business processes and integrated it with multiple other computer systems, resulting in increased staff efficiency through automation.• Improved proprietary applications with maintenance modules, reducing documentation overhead and accelerating system configuration from weeks to days.• Implemented a proprietary helpdesk ticketing system that enhanced due date generation for better SLA compliance, monitored workflow step completion to identify bottlenecks, automated document management, and provided performance metrics for workload planning.• Developed a proprietary project performance monitoring tool, reducing projected financial losses by up to 80%.• Achieved 150% of gross profit targets in the inaugural PV FSP program, which included system support and data visualization services.• Automated budget generation processes enabling a 1-day turnaround time for Business Development and Contract Modification support. Show less Management role leading process improvement initiatives, documenting design requirements, aligning system UX with business processes, creating validation test scripts, coordinating with various stakeholders, and overseeing system implementation, updates, and support processes.Highlights:• Implemented process automation using data integration to monitor clinical site activations and changes in regulatory reporting rules, resulting in a 90% reduction in manual review efforts required to ensure compliance with regulatory safety reporting.• Automated regulatory safety submission generation, delivery, and tracking, reducing the manual effort to 10 minutes per event.• Implemented the Safety Technical Operations Handbook and troubleshooting tool to expedite onboarding of new staff, facilitate cross training, and establish staff performance guidelines. Show less Management role overseeing and managing CDM activities, identifying and implementing process improvement opportunities, mentoring and managing staff, ensuring regulatory and corporate compliance, collaborating with cross-functional teams, managing client relationships, serving as the primary CDM escalation point, providing project KPIs for performance monitoring, and exercising project financial oversight.Highlights:• Implemented standardized project review processes, data entry definitions, and automated data analyses, resulting in a 75% reduction in manual data entry, improved data guidelines for more accurate KPIs, and heightened project risk awareness.• Standardized resource allocation processes and monitoring for the entire CDM organization by extending a tool initially designed for monitoring regional staff at one site to encompass all global CDM personnel and support five cross-site teams.• Implemented automated vendor partnership monitoring for 1000+ ongoing projects, enabling monthly financial forecasting of partnership impacts and correcting a 16% data entry error rate. Show less Management role overseeing and managing CDM activities, mentoring and managing staff, ensuring regulatory and corporate compliance, collaborating with cross-functional teams, managing client relationships, serving as the primary CDM escalation point, providing project KPIs for performance monitoring, and exercising project financial oversight.Highlights:• Automated data cleaning processes, resulting in a 30% reduction in process time and a 50% improvement in quality.• Created business modeling tools to forecast resource requirements, leading to substantial improvements in staff utilization and the proactive identification of potential future staffing challenges, including overstaffing or understaffing risks.• Implemented data cleaning KPI reports, identifying query closure rates vs. open queries to monitor clinical and data management staff performance and proactively identify potential timeline risks.• Developed a project monitoring tool to consolidate multiple related studies into a single budget, showing that despite initial inefficiencies, subsequent process improvements aligned overall performance with initial budget assumptions. Show less

  • Associate Director, Process and Systems Optimization

    Jun 2019 - Jul 2023

  • Safety Systems Consultant

    May 2015 - Jun 2019

  • Group Manager, CDM

    Mar 2012 - May 2015

  • Manager, CDM

    Jul 2008 - Mar 2012