Tynan Mir

Gained hands-on experience with senior RTD (Regulatory Affairs) team members, specifically in clinical testing and study risk determinations (SRD) for IRB and FDA submissions.

• Trained under senior regulatory affairs team members to learn the clinical testing processes and SRD assessments required for IRB/FDA submissions.
• Reviewed clinical study protocols for pharmaceutical partners, specifically contracted testing, and drafted SRD documentation for IRB/FDA submission and approval.
• Collaborated regularly with IRB/FDA representatives and pharmaceutical regulatory teams to discuss SRD submissions, ensuring alignment with regulatory guidelines.
• Developed study risk determination (SRD) guidance documentation and a decision map to support regulatory non-experts in identifying risk levels and drafting accurate language for regulatory submissions.

Implemented project management software to enhance project planning, business requirements, and data integrity, improving overall efficiency and productivity.

• Developed and executed marketing strategies to increase brand visibility, customer engagement, and market presence.
• Managed business finances, including budgeting, bookkeeping, payroll, and tax preparation, ensuring financial stability and compliance.
• Cultivated strong relationships with suppliers, negotiating favorable terms to ensure consistent product availability and cost efficiency.

Managed clinical testing and CAP/CLIA lab services projects for 20+ pharmaceutical partners, applying strong project management and leadership skills to achieve project deliverables on schedule, within budget, and with high customer satisfaction.

• Led cross-functional teams to ensure timely completion of projects, maintaining compliance with study protocols and meeting all regulatory requirements.
• Acted as the primary point-of-contact for pharmaceutical partners and internal team members, facilitating seamless communication and collaboration.
• Educated pharma partners and collaborators on RTD CAP/CLIA laboratory specimen processing and regulatory requirements to ensure smooth project execution.
• Reviewed and edited specimen collection manuals in accordance with study-specific testing requirements for specimen-submitting sites, ensuring compliance and accuracy.
• Organized and led project meetings, including setting agendas, scheduling, and editing meeting minutes to ensure timely follow-up and action.
• Oversaw daily operations of sample process flow, ensuring accurate data reporting, specimen processing, and tracking according to protocol.
• Implemented project management best practices within the clinical sciences team, promoting continuous process improvements and quality assurance through knowledge-sharing and experience exchange.

Applied strong project management and data oversight skills to ensure successful global clinical trial deliverables were achieved on schedule, within budget, and with high customer satisfaction.

• Managed US-domestic and international external vendors across laboratory supply, shipping/logistics, data generation/management, biospecimen processing/testing/storage for early to late-stage oncology clinical trials.
• Collaborated with global project managers, legal, and finance teams to initiate and negotiate vendor contracts and service agreements.
• Led project study data team; delegated tasks and oversaw data deliverables, ensuring timely completion and high quality.
• Acted as a key consultant in the design and review of clinical trial protocols, ICFs, CRFs, statistical analysis plans, and clinical study reports, in close collaboration with medical monitors, biostatisticians, regulatory affairs, and senior management teams.
• Created and managed clinical trial startup documentation including clinical monitoring plans, supply plans, and investigational drug supply plans.
• Provided expert input on clinical operations and trial monitoring functions during clinical trial start-up activities such as EDC builds and (a)CRF completion guidelines.
• Managed clinical trial site monitoring metrics (e.g., SDV progress, query aging, CRF completion, monitoring frequency) to optimize performance, quality, and ICH/GCP adherence.
• Oversaw the migration of clinical trial data from legacy systems into new clinical database platforms.
• Developed and managed project-specific biospecimen tracking dashboards for internal stakeholder visibility, ensuring seamless data reporting and protocol compliance.
• Ensured the integrity of clinical data by conducting quality assurance/quality control (QA/QC) activities and performing data reconciliation as needed.
• Managed data transfer specifications (DTA), tracked data release processes, addressed pharma data inquiries, and assisted with database corrections and locks.
• Monitored database performance, identifying and troubleshooting issues to ensure data integrity and optimal system performance.

Managed high-complexity clinical testing for early to late-phase oncology clinical trials and CAP/CLIA lab services, supporting 20+ domestic and international pharmaceutical partners.

• Served as the primary point-of-contact for pharmaceutical partners, addressing laboratory testing, operational, regulatory (IVDR), and data deliverable needs.
• Provided customer portal training and support to sponsor personnel, ensuring smooth communication and timely resolution of issues.
• Oversaw internal cross-functional team activities to ensure compliance with testing protocols, study objectives, and regulatory requirements.
• Developed clinical testing plans and protocols to train study team members on operational and testing procedures.
• Managed the full lifecycle of clinical projects, from initiation through closure, ensuring on-time and within-budget delivery.
• Identified potential project risks and collaborated with management to develop and implement mitigation strategies.
• Served as the primary liaison for pharma partners and external stakeholders (CROs, site personnel) to facilitate information flow and project coordination.
• Managed biospecimen sample process flow, including receipt, processing, data reporting, storage, shipment, and disposal, ensuring protocol compliance.
• Built customized workflows within company databases to streamline biospecimen testing and project task tracking for internal stakeholders.
• Led clinical data quality assurance and control efforts to ensure data integrity and protocol compliance throughout the study lifecycle.
• Collaborated with Quality department leads to execute and support pharma client and regulatory audits.
• Led and provided educational training to junior and senior project managers; developed training materials and organized onboarding activities for new employees.
• Reviewed and monitored Data Transfer Specification (DTA) documentation, tracked data milestones, managed pharma data inquiries, and executed database corrections for discrepancies.
• Ensured timely data reconciliation, reviewed data completeness, and supported pharma with database lock activities.

Supported the operational aspects of ongoing projects across various departments (Quality, Data Management, CAP/CLIA Lab, Assay Development, Pathology, etc.), acting as the liaison between project teams and project management staff.

• Applied specialized knowledge in functional areas to drive cross-functional collaboration, ensuring successful project completion from scope definition through implementation and validation.
• Took meeting notes, tracked action items, and provided administrative support to senior project managers to ensure timely follow-up and progress.
• Facilitated communication on project updates to organizational groups and stakeholders, ensuring transparency and alignment.
• Accessioned received specimens into the CAP/CLIA lab, drafted and submitted biomarker testing orders, and prepared cases for pathology scoring in alignment with project protocols.
• Entered clinical data and served as a pathology scribe, ensuring accurate documentation and data integrity.
• Conducted digital slide imaging of biomarker cases using Ventana and competitor laboratory instruments to support accurate analysis and reporting.
• Managed and monitored regular quality reviews of clinical data, ensuring compliance with regulatory standards and internal quality expectations.

Managed product inventory, including procurement, monitoring, and distribution of materials for retail sales and commercial/government projects.

• Supervised cashier and customer service teams, including training, scheduling, performance evaluations, and task delegation to ensure high levels of service and productivity.
• Maintained and updated a sales database for 350+ in-house commercial accounts, ensuring accurate records and streamlined operations.
• Researched and tracked new product releases to inform procurement strategies and enhance product offerings.
• Submitted daily/weekly purchase orders to 20+ vendors, ensuring timely and cost-effective material availability.
• Delivered exceptional customer service to both customers and account representatives, resolving issues and providing product recommendations.

Supported non-profit donation procurement and health care initiatives, including free screening clinics and educational programs for underprivileged children in South Tucson, Arizona.

• Solicited contributions from charitable foundations, registered and prospective donors, vendors, and corporate partners, securing monetary and in-kind donations for Carondelet St. Mary’s Hospital.
• Created, organized, and submitted grant documentation, ensuring compliance with funding requirements and alignment with hospital objectives.
• Assisted the Parish Nurses of St. Mary’s Hospital in organizing and executing free health screening clinics, providing essential services to underserved communities.
• Developed and prepared educational materials on topics such as healthy lifestyle, nutrition, disease prevention, gang violence, drug prevention, and teenage pregnancy for K-12 students from lower socio-economic backgrounds.
• Coordinated outreach efforts and built relationships with local organizations to promote community wellness and enhance program participation.