As an important member of our talented Hospital Patient Monitoring (HPM) Clinical Affairs team, the Associate Director – Clinical Operations, is responsible for day‑to‑day Clinical Operations/team Management and providing expertise in clinical research process legislation, ICH‑GCP guidelines, improving efficiency in clinical execution.
Responsibilities
* Responsible for planning, direction, and coordination of clinical programs and activities, including overseeing Clinical Evidence planning and generation, Clinical PIL tools, process implementation, ensuring compliance with applicable laws, regulations, and standards.
* Ensures accountability for process execution, system functionality, backlog management, and improvement initiatives.
* Assists in the updates and enhancement of quality system processes for Clinical & Medical Affairs, aligning with business strategies, roadmaps, and Informatics demands.
* Serves as a primary point of contact between Clinical & Medical Affairs and other departments, driving cross‑function cooperation and ensuring stakeholder alignment.
* Coordinates change requests and submissions, ensuring all critical parties are aligned and changes are effectively implemented.
* Works with a diverse global team, emphasizing project management, business analysis, service management, solution ownership, and validation to achieve targeted outcomes.
* Promotes application standardization through shared processes, data harmonization, and architectural compliance, while fostering strong relationships.
* Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives.
* Ensures compliance with training requirements and driving continuous improvement for the clinical programs.
* Supports the development of the Clinical & Medical Affairs team by sharing resources, knowledge, and experience, and leading initiatives that enhance the organization.
Qualifications
* Minimum of 10+ years of Clinical Operations experience within Medical Device Clinical Research and FDA‑regulated OEM Medical Device product environments; experience in Patient Monitoring is desired.
* Minimum of 3+ years of functional management of Clinical teams, including budgeting, training, staff development, performance management, resource management, and continuous improvement.
* Proven expertise in leading Clinical Operations, execution, research process legislation, ICH‑GCP guidelines, planning, and associated technologies/tools.
* Detailed understanding of Clinical & Medical Affairs, able to propose innovative ideas, provide meaningful input, and contribute to senior leadership discussions.
* Deep understanding of Health Care Research methodology, regulations, laws, and guidance in major markets such as EU, USA, UK, AUS, Japan, and China.
* Proven experience in building and cultivating strong working relationships and partnerships with business stakeholders/functions and influencing internal/external service providers towards achieving strategic objectives.
* Minimum of a Bachelors’ Degree (Required) in Biology, Health Science MPH, Nursing or equivalent; Master’s/PhD desired. Six Sigma, Safe, Agile, PMP certifications desired.
* Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
Compensation & Benefits
* Pay range in Cambridge, MA: $144,900 to $231,840; actual pay offered may vary within the posted ranges depending on job‑related knowledge, experience, business needs, geographical location, and internal equity.
* Eligible to participate in our comprehensive Total Rewards program, including generous PTO, 401k (up to 7% match), HSA, stock purchase plan, education reimbursement, and more.
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