Dan S. Akilapa

Dynamic and mission-driven Senior Clinical Trial Manager with over 10 years of experience leading end-to-end, multicountry pivotal and late-phase clinical trials for implantable hearing solutions, audiology diagnostics, and auditory health management. Proven expertise in generating FDA-defensible (IDE/PMA) and EU MDR-compliant clinical evidence for complex medical devices. Deeply specialized in hearing loss rehabilitation, tinnitus management, and auditory neurology.

Expert at managing global clinical operations, authoring complex protocols, and leading cross-functional teams (Clinical Development, Medical Affairs, Clinical Evaluation, Regulatory, and Quality) to support product registration and clinical claims. Passionate about advancing auditory health, bringing a highly collaborative, strategic, and low-ego approach to translating complex clinical data into life-changing hearing solutions.

Senior Clinical Trial Manager - Sanofi

(2023-08)

• Coordinated Own strategic planning, oversight, and accountability for complex, multi-country pivotal trials for implantable hearing solutions, ensuring strict compliance with ICH E6 GCP, ISO 14155, FDA IDE, and EU MDR regulations within budget and timelines.
• Serve as the primary clinical subject matter expert and single study owner, holding full decision-making authority across all trial activities and driving the strategic direction of clinical development programs to align with business objectives.
• Lead the authorship and development of key study documents, including protocols, ICFs, EDC specifications, statistical analysis plans, and clinical study reports (CSR), ensuring high-quality data collection and statistical integrity.
• Direct global study delivery by aligning Clinical Operations, Clinical Evaluation, Medical Affairs, and the Clinical Development team to ensure consistent, compliant, and strategically aligned execution.
• Lead strategic global vendor selection and governance; oversee CRO and vendor performance against study requirements, escalating issues and driving accountability to ensure high-quality deliverables.
• Manage global trial budgets, develop country allocation and enrollment strategies, and oversee trial-level risk identification, approving integrated mitigation and contingency plans drawing on scientific and regional expertise.
• Build and lead a high-performing team of data managers and scientists; establish data management capabilities and lead the build-out of Global Clinical Trials infrastructure, including SOPs, systems, governance, and continuous improvement.

Clinical Trial Manager - Novartis

(2021-05 - 2023-07)

• Managed Directed clinical operations for hearing rehabilitation and tinnitus management portfolios, focusing on advanced hearing diagnostics and digital auditory interventions.
• Contributed to clinical research strategy, ensuring alignment of study design, digital endpoints, and operational approaches with intended clinical claims, market indications, and FDA/EU MDR regulatory pathways.
• Managed contracts, site budgets, and revenue forecasting for multi-country studies, ensuring strict adherence to contracted scope and proactively addressing financial risks.
• Drove study-level strategic decision-making by proactively identifying emerging risks in global trial execution, developing scenario plans, and proposing innovative solutions to keep studies on track.
• Supported regulatory submissions with the FDA and EU Notified Bodies, preparing study documentation for regulatory audits and ensuring continuous inspection-readiness of the eTMF.

Senior Clinical Research Associate - Rinri Therapeutics

(2019-02 - 2021-04)

• Trained Conducted site identification, selection, and initiation for multi-country audiology and hearing diagnostics studies, ensuring strict alignment with ISO 14155 and ICH-GCP guidelines.
• Reviewed and monitored clinical data utilizing EDC platforms, ensuring endpoint protection for audiometric thresholds, speech-in-noise performance, and tinnitus matching metrics.
• Supported regulatory and ethics submissions for hearing device studies, tracking approvals and maintaining accurate records of essential documents and correspondence with local IRBs/ECs across multiple jurisdictions.
• Trained site staff and remote monitoring teams on protocol requirements, audiology-specific digital endpoints, and GCP compliance, fostering strong investigator relationships.

Clinical Research Associate II - Parexel

(2015-10 - 2018-12)

• Managed Trial Master Files (eTMF) for large-scale, multi-country medical device trials, ensuring continuous inspection-readiness for sensory and auditory health endpoints.
• Monitored site performance and financial tracking, assisting in the reconciliation of site payments and tracking of budget modifications for device-driven trials.
• Performed pre-study site evaluations, remote monitoring, and study close-out visits, verifying regulatory documentation and digital source data for audiology studies.
• Interacted daily with sponsors, investigators, and tech vendors to resolve trial-related issues promptly, maintaining strict study timelines for consumer-facing and clinical research.

Clinical Research Associate I - MCRA

(2013-05 - 2015-07)

• Performed clinical research activities for decentralized clinical trials (DCT) in auditory health, including remote site identification, digital subject recruitment, and remote source data verification.
• Coordinated the submission of regulatory documents to local IRBs/ECs, utilizing eConsent and digital health platforms while maintaining strict confidentiality of patient data.
• Assessed incoming digital source documentation and ePRO data for accuracy and completeness, identifying discrepancies and implementing corrective actions remotely in adherence to GCP.

Clinical Research Coordinator - Memorial Hermann

(2010-01 - 2013-03)

• Coordinated clinical trial activities and ensured compliance with regulatory requirements.
• Managed patient recruitment efforts and maintained accurate enrollment records.
• Oversaw data collection processes and maintained study documentation integrity.
• Scheduled and organized study visits for participants and staff members.
• Monitored study progress and reported findings to stakeholders regularly.
• Assisted in preparing regulatory submissions and ethical review applications.
• Monitored patient safety during clinical trials according to established guidelines.
• Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
• Reviewed CRFs for completeness and accuracy before database entry.
• Reviewed medical records for accuracy of source documentation prior to database lock.
• Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.

Bachelor of Science - Biology