Director of Clinical Operations
Ardea Outcomes is seeking a Director of Clinical Operations to join our growing team. The role will report directly to the CEO. This position will be remote within Canada, and the candidate will be based out of their designated home office.
About Ardea Outcomes
Ardea Outcomes is a purpose-led boutique contract research organization focused on improving health outcomes through patient-centered research. Founded in 2000, Ardea Outcomes is a globally recognized, remote-first company registered in Halifax, Nova Scotia, with employees spanning the country. We work with pharmaceutical companies, patient advocacy groups, and academic experts to elevate the patient voice in clinical research, moving from "what's the matter" to "what matters most" for patients and caregivers through Goal Attainment Scaling (GAS).
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Our offerings include end-to-end research services and digital products to support GAS enablement:
GAS Training Programs for Raters and Clinicians
Protocol and GAS study plan development
Licensing and support for our patent-pending GAS electronic data capture technology, GoalNav ®
GAS clinical data management and data analytics services
Medical writing and results dissemination at conferences and key industry events
Ardea Outcomes works to a high standard of excellence with top pharmaceutical companies in the clinical development and post-market space.
Job Overview
The Director of Clinical Operations at Ardea Outcomes is a cornerstone of leadership, overseeing all clinical functions to ensure alignment with organizational goals and excellence in patient-centered research through Goal Attainment Scaling implementation. This role provides strategic oversight across multiple areas, including project management, training, and support, GAS eCOA software, clinical data management, and qualitative research. As a trusted leader, the Director collaborates with the CEO and the leadership team to drive innovation, regulatory compliance, and operational excellence in client projects, fostering collaboration across functional teams to deliver impactful outcomes for clients and patients.
Why this Position is Key to Our Shared Success
The Director of Clinical Operations ensures that Ardea Outcomes operates at the highest standard of clinical excellence, delivering quality-driven, patient-centered solutions through Goal Attainment Scaling implementation. This role is integral to shaping our operational strategy, mentoring our teams, and supporting cross-functional collaboration to achieve our shared mission. By ensuring seamless project execution, client satisfaction, and the integration of innovative methodologies, this position supports the continued growth and success of the organization.
How You Will Contribute
Leadership and Project Oversight
Oversee clinical operations, including project management, training, GAS eCOA software, clinical data management, and qualitative research functions.
Accountable for the execution of new projects per contract while optimizing speed, quality, and delivery cost, as well as ensuring consistent use of study tools and compliance with standard processes, policies, and procedures.
Collaborate with the CEO to align clinical strategies with business objectives and client needs.
Set the objectives of the core project team and sub-team(s) according to the agreed-upon contract, strategy, and approach, effectively communicate, and assess performance.
Accountable for developing integrated study management plans with the core project team.
Ensure the financial success of the project.
Forecast and identify opportunities to accelerate activities to bring revenue forward.
Mentor and develop teams to build capacity and align team goals with organizational objectives.
Strategic and Operational Excellence
Provide strategic oversight for service delivery, including evaluating and integrating new technologies and methodologies to ensure clinical operational excellence.
Build and lead the cross-functional project team; manage cross-collaboration of the core team and overall project delivery to support milestone achievement; and manage study issues and obstacles.
Align clinical strategies with company goals, ensuring compliance with regulatory standards.
Ensure regulatory compliance and adherence to ICH Guidelines and regulatory and ethical standards.
Ensure project quality by identifying, mitigating, and monitoring risks.
Client and Stakeholder Engagement
Serve as project director and key relationship manager with clients and research partners. Communicate/collaborate with business development, as necessary.
Build strong client relationships to foster long-term partnerships.
Represent Ardea Outcomes in client meetings, strategic discussions, and conferences.
Oversee client deliverables, ensuring quality, timeliness, and alignment with expectations.
Support business development in identifying resources and scoping for new projects.
Participate in proposal presentations in partnership with Business Development and may lead the presentations for specific project types.
What Will Help You Be Successful
Bachelor's degree in business, scientific, or a technical discipline.
Advanced degree (Master’s or higher) in Public Health, Life Sciences, or a related field is preferred.
Project management and clinical operations experience within the drug development industry and previous CRO experience are preferred.
7+ years of clinical operations experience, with at least 3 years in leadership roles.
Exceptional leadership, organizational, and strategic planning skills.
Proven ability to manage diverse teams and functions effectively.
Strong project management skills with experience in financial analysis and budget management.
Strong knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements.
Excellent software and computer skills, including Google Workspace and MS Office applications.
Excellent ability to manage multiple tasks simultaneously and solve problems creatively.
Able to make informed decisions in a fast-paced and sometimes ambiguous environment.
Excellent communication skills with the ability to build and maintain strong relationships.
High attention to detail and ethical behavior.
Proactive approach to learning and skill development.
Adaptability and a positive outlook towards continuous growth in response to changing organizational demands.
Work Conditions and Physical Requirements:
Fully remote position from a designated home office in Canada.
Flexibility to work across time zones is required.
National and international travel is required for client and company meetings and to represent Ardea Outcomes at meetings and conferences.
What We Offer
We offer competitive compensation packages to match your skills and experience, including salary and benefits. Benefits include, but not limited to:
4 weeks vacation
12 sick days
13 Paid Holidays
Flexible schedule
Professional Development
Home Office Setup Stipend
Group Health Benefits Plan
What To Expect
We will closely review all applications and cover letters.
If you are selected as a top candidate, expect an invitation to chat with one representative from Ardea Outcomes.
Selected candidates will proceed to a virtual interview with 2-3 representatives from Ardea Outcomes and may be asked to complete an online assessment before or after this interview.
Finalists may participate in a second-round interview or skills activity.
Applications will be accepted until 11:59 PM ADT on January 12, 2024.
Please visit our careers page to see more job opportunities.