Don Merriman

· Lead and coordinate cross-functional clinical trials across North America, APAC, and EMEA, ensuring adherence to protocols, regulatory standards, and timelines. · Activated multiple clinical sites across North America, APAC, and EMEA regions within a 12-month timeframe, ensuring adherence to protocol requirements and regulatory standards. in the United States, Bangladesh, and Uganda. · Achieved 100% compliance with ICH-GCP and FDA regulations in all clinical trials managed, ensuring no critical findings during audits. · Activated multiple sites globally, including the United States, Bangladesh, and Uganda, improving site start-up timelines by 20%. · Reviewed, edited, and collaborated on the development of Work Instructions (WI) and procedural documents to ensure clarity, accuracy, and compliance with organizational standards.

• Raised $150,000 in pre-seed funding, securing a $2 million pre-revenue valuation through investor pitches and business development efforts. • Led the development of two OTC drug SKUs from concept to stabilized drug in under 12 months, accelerating the timeline by 25% compared to the initial schedule. • Streamlined the manufacturing process by introducing quality control checkpoints, resulting in a 15% reduction in production errors. • Managed project budgets, achieving a 20% reduction in costs by optimizing contract negotiations with manufacturers and vendors. • Developed key operational initiatives to drive and maintain substantial business growth. • Reviewed individual department performance and worked with leadership to improve processes, procedures and practices. • Spearheaded product development of two SKU's • Followed compliance of OTC monograph. • Experience with the Homeopathic Pharmacopoeia of the United States • Completed FDA CDER National Drug Code application process for two products, achieving approval within 3 months of submission. • Conducted target market research to scope out industry competition and identify advantageous trends.

• Successfully coordinated the start-up and activation of 114 sites across North America, EMEA, and APAC regions • Managed process for planning and procuring ancillary clinical supplies • Created and manage study specific tools such as recruitment and retention materials and study newsletters • Contribute to and support with the preparation, writing and review of study related documents including but not limited to, clinical protocols, consent forms, study guides, monitoring plans, e(CRF)s, subject information sheets, clinical study report, regulatory submissions and publications. • Global experience: North America, EMEA, Japan, and APAC. • Facilitated authoring of Investigational Product Information Manual (IPIM) and study specific Important, Protocol Deviation (IPD) list • Compiled IRB/EC submission documentation • Quality Check study protocols and ICFs • Prepared Clinical Study Team (CST) meeting agendas and minutes • Managed global versioning and distribution of informed consent forms (ICFs) • Facilitated cross functional meetings • Contributed to the authoring and review of clinical study documents, ensuring 100% adherence to ICH-GCP standards. • Managed lab vendors and CTSM vendors, ensuring 100% on-time delivery of clinical supplies and reducing supply chain delays by 20%. • Reviewed the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF) • Enhanced CTMS and eTMF (Veeva Vault) data quality by implementing regular reconciliation processes, improving data accuracy by 5% and ensuring audit readiness.

• Manages and operationally delivers clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities and close-out. • Ensures appropriate communication and ongoing leadership of assigned trial(s) by working in close collaboration with the sponsor and other functional team members. • Identifies challenges to study timelines/deliverables and offers creative action plans to the team/sponsor. • Maintains team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction. • The responsibilities listed are a general overview of the position and additional duties may be assigned.

• Instructed students in lab by teaching safety protocols for proper use of chemicals and safe disposal of hazardous materials. • Engaged students and promoted intellectual curiosity through hands-on experiments, PowerPoint presentations and mnemonics to provide positive attitude towards scientific processes. • Communicated frequently with parents, students and faculty to provide feedback and discuss instructional strategies. • Incorporated exciting and engaging activities to achieve student participation and hands-on learning. • Evaluated and revised lesson plans and course content to achieve student-centered learning. • Participated in department meetings to provide input to colleagues about student achievement and improvement. • Managed laboratory and stockroom by pricing and ordering chemical supplies and equipment.

• Created new shipping process for bio-specimens • Processes and ships lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards. • Develops procedures for lab collection and storage. • Collected, evaluated and modeled collected data • Gathered, processed and shipped lab specimens

• Collect, complete and submit all documents required for study start-up and for study initiation • Complete 1572 and/or Investigator Agreement Form (and obtain PI signatures) • Collect lab certifications (CLIA and CAP) and lab director's CV and license for local and central labs; submit copies to the sponsor and file copies in the regulatory binder • Complete IRB submission forms and collect all supporting documents • Submit all necessary documents to the IRB (submission form, CVs, licenses, informed consent, advertisements, etc.) and file copies in the regulatory binder • Ensure all regulatory documents are kept up to date and filed in the regulatory binder