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 Managers Site Partners) and lead a matrix of 1530 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

• Bachelors 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 skills in a global fast-moving setting.

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS

• Experience delivering evidence for regulatory interactions involving digital health tools.

• Background in digital health/SaMD DHT analytics or mobile app-enabled interventions; comfort working with Product/Engineering on release governance during trials.

• Advanced degree or candidate (MS MA MPH) or equivalent.

Tools & Systems

• Proficiency in CTMS EDC eTMF eCOA/ePRO platforms and collaboration tools; familiarity with dashboards/metrics used for centralized monitoring and adherence analytics.

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.