Director, Clinical Operations

Clinical Research Operations Director 

Vancouver, WA (Onsite), Remote/Hybrid (US-based)

We are seeking a dynamic Clinical Research Operations Director to lead our clinical research initiatives and manage the global operational aspects of our clinical trials. This pivotal role combines the scientific expertise of clinical research with the organizational skills of operations management to ensure the efficient and effective execution of studies across different therapeutic and geographic areas that meet regulatory standards and company objectives. The ideal candidate will have a strong background in the life sciences, a deep understanding of clinical trial processes, as well as regulatory affairs to oversee both the scientific and logistical elements of clinical research.

Responsibilities: 

Trial Oversight and Execution:

• Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards.
• Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study’s goals, budget, and timelines.
• Oversee junior staff assigned to a project, but remain responsible for the success of a clinical project or program.

Operational Management & Compliance:

• Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuring high quality, compliance with the study protocol and regulatory requirements across all trials.
• Ensure robust patient recruitment and retention strategies are in place and effectively executed.
• Drive Program level consistency in data collection and compliance
• Drive analysis, troubleshooting, and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies.
• Ensure accurate data collection, documentation, and record-keeping.
• Responsible for the integrity, confidentiality, and security of all research data.

Risk Management & Strategy:

• Identify potential risks and implement contingency plans.
• Keep abreast of industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies.

Collaboration & Communication:

• Develop and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure collaboration and alignment on trial objectives.

You Will Be Successful If You:

• Effectively build rapport and confidence when presenting trial updates, data, and regulatory information to Clinical Research Investigators and their staff.
• Are an exceptional leader who can successfully coordinate multiple complex clinical projects simultaneously across cros