As Founder and Principal Consultant of Inquiry Research, LLC, I provide strategic consultation to C-level and senior executives in life science organizations, helping them make informed decisions. With expertise in clinical development strategy and execution, I support and oversee various projects, ensuring teams meet their objectives and protocols are planned for success. I also serve in interim C-Level positions focusing on meeting significant milestones, strategic outsourcing, resource allocation, budget optimization, and overall management to facilitate clinical development. My passion lies in utilizing data analytics and clinical operations to make informed decisions.Selected Achievements:• Delivered expert consultation and strategic planning that enhanced executive decision-making for prominent life science organizations.• Pioneered operational improvements, resulting in up to a 50% efficiency boost in clinical projects by employing innovative resourcing and technology solutions.• Successfully launched a GCP-compliant Clinical Quality Management System, projecting a reduction in non-compliances by over 30%, which in turn amplified senior management oversight and fortified our commitment to quality.• Spearheaded efforts in refining vendor-alliance selection and internal resource processes, predicting a 50% cost reduction and guaranteeing unparalleled service quality to our clients and partners.• Conceived and directed strategic initiatives, introducing new Risk-Based Monitoring and Patient Recruitment service lines.

As a founder of a small CRO, I led various aspects of the organization's evolution. From the inception of InQuiry Research Services to our merger with DZS, I played a crucial role in defining the company's trajectory. I have overseen its operations across multiple domains, including sales, marketing, and finance, and project planning and execution. I ensured the alignment of our service and technology solutions with client requirements and market trends. Through strategic planning and hands-on leadership, I helped our company consistently achieve its yearly corporate objectives and multiple successful exits.Selected Achievements:• Steered the completion of over 200 projects, leading to more than 25 global drug/device regulatory approvals, contributing to 15+ industry publications, and earning a commendable 90% approval rating from our clients.• Oversaw the launch of a cutting-edge CTMS and EDC solution, which boosted our revenue by 40% and saw its adoption by over 70 clients.• Innovated and introduced a pioneering RBQM solution that decreased potential risks by an estimated 20-30% in clinical trial processes, ensuring safer and more streamlined trials.• Pioneered the Safety Surveillance service line, resulting in a 10% revenue uptick in its debut year, further extending our offerings to existing clients.• Fostered and nurtured strategic alliances with prominent industry frontrunners, securing over $8M in fresh contracts and fortifying our market stance and reputation.• Played an integral part in increasing the company's valuation by 400% by pinpointing and capitalizing on lucrative business avenues and strategic endeavors.

Small CRO with a focus on small to mid-size biopharma and medical device companies. Trusted service provider focused on offering deep knowledge, flexible project models, technology, and operational expertise to organizations across the Life Sciences industry.

As the Director of Clinical Operations and Strategic Services at ConvaTec, Skillman, I led the clinical development organization. My responsibilities included overseeing critical functions such as project management, clinical data management, clinical programming, medical writing, and clinical supplies. A key aspect of my role was to develop and execute strategic initiatives aligned with corporate goals and objectives. I achieved this by establishing custom metrics and adhering to rigorous timelines to ensure the timely completion of clinical trials and the rollout of strategic projects. This approach enhanced our operational efficiency and effectiveness and helped us achieve our goals within the specified timeframe. As the face of Clinical Development, I represented the organization in critical platforms such as strategic planning sessions, senior management meetings, product development discussions, and cross-functional team engagements. My work ensured our operational strategies aligned with the company's objectives and goals.Selected Achievements:• Enhanced our operational capabilities by implementing cutting-edge technology solutions, which improved project delivery timelines by 25% and curtailed operational expenses by 15%.• Strategically allocated and supervised a robust US/EU budget, touching approximately $25M, ensuring its prime utilization across both clinical development and medical communications ventures.• Spearheaded groundbreaking strategic initiatives that transformed our clinical trial processes, slashing project deliverable timelines by 25%, and expediting the global delivery of vital medical products and information.• Pioneered the adoption of metrics-driven strategies, propelling a significant uptick in clinical operations performance and making a palpable positive difference to our corporate objectives and the company's bottom line.

During my tenure at Campbell Alliance, I provided strategic analysis to Pharmaceutical and Biotechnology firms, which helped them to create effective clinical development strategies. My role was pivotal in identifying new business development opportunities and maintaining relationships with key customer accounts. I worked to improve our operational standards, leading various clinical-related initiatives, including refining protocol development processes and closely supervising CRO activities. I also played a crucial role in implementing technology solutions to support growth, such as selecting an EDC system, enhancing processes, and deploying a CTMS.Selected Achievements:• Collaboratively worked on groundbreaking clinical strategies that bolstered Pharmaceutical and Biotechnology firms, a move that facilitated quicker drug approvals and ensured stringent regulatory compliance.• Successfully expanded Campbell Alliance's horizon by unveiling and capitalizing on new business development possibilities within essential accounts.• Orchestrated strategic clinical initiatives that injected efficiency into our protocol development and CRO oversight processes, effectively trimming project timelines and boosting operational effectiveness by an impressive margin of 15-25%.• Spearheaded technology-driven initiatives, culminating in the judicious selection and rollout of Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS), setting the stage for a 50% surge in database lock times, ensuring data accuracy.

At Baxter Healthcare, I significantly integrated electronic data capture systems (EDC) and clinical technologies for clinical trial management. As the Global Director, I led the global efforts for Renal Clinical Data Management (CDM) and Programming, collaborating with various departments such as statistics, clinical operations, regulatory, I.T., and marketing. My primary focus was achieving departmental targets and championing CDM/Programming objectives. I also emphasized promoting inter-departmental understanding and synergy regarding the services offered by CDM/Programming. Additionally, I supported the development and strict adherence to robust data management, programming standards, and system compliance, ensuring alignment with critical regulatory standards such as ICH, FDA, GCDMP, and others.Selected Achievements:• Strategically streamlined clinical trial data management processes, achieving a notable reduction in the timeline by 20-25%, primarily due to the implementation of aggressive timelines and precise coordination with multifaceted project teams.• Spearheaded the selection and roll-out of an electronic data capture system, which bolstered data accuracy by 20% and accelerated the pace of data collection by 3-4 weeks per visit. This key change fortified the trustworthiness and consistency of our clinical trial data.• Orchestrated heightened project efficiency by formulating standardized tools, enabling precise projection and allocation of necessary resources, a move undertaken in close collaboration with the Clinical Affairs management team.• Augmented staff proficiency with the new data capture systems and clinical trial protocols. This was accomplished via a targeted training program, which yielded a significant 20% dip in protocol deviations and violations, marking a remarkable stride in process integrity.

As the Director of Clinical Data Management for North America at Kendle International (now Syneos), I was responsible for managing the North American Clinical Data Management (CDM) Department. I coordinated efforts across multiple sites and supported the Biometrics sales and marketing endeavors across North America, increasing the department's visibility and stakeholder engagement.I nurtured sponsor relationships, ensuring they continuously received value from our services and fostering long-lasting partnerships. Additionally, I guided the sales and operational strategy within the CDM department, emphasizing the importance of refining overall efficiency and achieving targets. I also evaluated and enhanced staffing and compensation structures, ensuring our CDM team remained competitive through comprehensive training and development initiatives.Selected Achievements:• Successfully led a dynamic team of over 140 professionals, efficiently handling a top tier folio of 70+ projects; this leadership translated to a notable 25% uptick in project completion efficiency during my tenure.• Spearheaded and executed integration activities across all Kendle data management sites globally. This endeavor notably enhanced operational synergy, paving the way for a blockbuster drug approval.• Created and rolled-out functional requirements for clinical software, boosting system performance and broadening system functionality.• Ensured the cultivation and fortification of sponsor relationships, achieving a 95% satisfaction rate amongst partners.• Proactively assessed and remedied staffing and compensation challenges, which led to a drop in employee turnover rates to a mere 3%.