Senior Manager, DHM Clinical Development Integration

ROLE SUMMARY

The Digital Health and Medicines – Clinical Development Integration Senior Manager, provides end to end management for one or more interventional studies designed to demonstrate the clinical contribution of Digital Medicines tools alongside a sponsor medicine. They will own operational delivery (startup through closeout), evidence generation strategy for software drug labeling, vendor/CRO oversight, inspection readiness, data integrity, risk and budget management, and cross functional orchestration (ClinDev, Biostats/GBDM, Safety, Regulatory, QA, Digital/Tech). The role ensures trials are executed to ICH GCP, and internal SOPs.

ROLE RESPONSIBILITIES 

Trial Strategy & Design

• Translate the digital health strategy into an executable trial plan, ensuring endpoints and analyses reflect the impact of digital tools on patient experience and data quality.

• Partner with Clinical/Medical, Biostatistics, Regulatory, Safety, and Digital teams to finalize protocol, SAP inputs, and usability considerations for digital components.

• Integrate eCOA/ePRO/DHT strategies, data flows, and site/patient onboarding plans per internal protocol guidance.

Operational Leadership

• Lead end-to-end execution (site activation, enrollment, treatment, follow-up, DB lock, CSR contributions) with on-time FPI/LPI/LPO and quality targets.

• Drive vendor/CRO governance for digital platforms (e.g., ePRO apps, wearable devices, data hosting) including KPIs, SLAs, and issue escalation.

• Ensure TMF completeness, deviation management, and inspection readiness at all times.

• Provide strategic oversight for a national network of clinical trial sites, ensuring operational excellence and regulatory compliance for DTx trials.

• Design and implement global training initiatives for site staff, focusing on digital health tool integration and protocol adherence.

• Act as the primary operational partner to global clinical leads and clinicians, aligning study execution with scientific and medical objectives.

• Steer high-performing teams, championing a culture of quality and ensuring alignment with organizational goals and best practices.

​Quality, Compliance & Risk

• Maintain compliance with ICH-GCP, internal SOPs, data privacy/security controls, and validated clinical systems; coordinate with Digital/Tech for app releases and cybersecurity.

• Own the operational risk management plan (including device/app availability, data signal detection, adherence monitoring) and lead CAPAs as needed.

Interfaces & Communication

• Chair cross-functional trial forums; provide clear status, risk/mitigation, and budget forecasts to governance.

• Enable site readiness and training for digital components (patient onboarding, consent language, troubleshooting pathways).

People & Vendor Leadership

• Oversee product and trial readiness, leading cross-functional teams to ensure all digital and clinical components are inspection-ready.

• Manage/coach a small team (e.g., Global Study Manager[s], Site Partners) and lead a matrix of 15–30+ contributors; foster a quality-first, patient-centric culture.

• Lead escalation and resolution of complex vendor issues, including those impacting multiple studies or regions.

• Drive innovation in vendor partnerships, including piloting new technologies and operational models.

BASIC QUALIFICATIONS

• Bachelor’s degree in life sciences, engineering, nursing, or related field.

• 6+ years of clinical research experience with 3+ years leading interventional trials with digital tools.

• Demonstrated track record of CRO/vendor oversight, site performance management, and TMF/inspection readiness.

• Hands-on experience with eCOA/ePRO/DHT in pivotal trials; strong grasp of data flows, device logistics, and compliance/usability considerations.

• Expert knowledge of ICH-GCP and sponsor SOPs; familiarity with privacy/security expectations in clinical systems.

• Exceptional cross-functional leadership, communication, and decision-making ski