Project Manager, Clinical Operations

Ardea Outcomes is seeking a Project Manager to support our clinical operations service delivery and join our growing team. The role will report directly to the Director of Clinical Operations. 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 Project Manager at Ardea Outcomes is the driving force behind the successful delivery of clinical research projects. This role manages project timelines, budgets, and deliverables while ensuring compliance with regulatory standards and company processes. As the central hub between internal teams, clients, and external stakeholders, the Project Manager is pivotal in seamlessly executing our Goal Attainment Scaling endpoint implementation in clinical trials. Their ability to anticipate risks, align resources, and ensure quality outcomes directly supports the organization’s mission and values.

Why this Position is Key to Our Shared Success

As the operational link across teams, the Project Manager ensures that clinical trials are executed efficiently and effectively, meeting client expectations and upholding Ardea Outcomes’ commitment to excellence. This role is critical in maintaining momentum across projects, fostering collaboration, and supporting innovative approaches to patient-centered research and Goal Attainment Scaling implementation, ultimately contributing to our team's and client's success.

How You Will Contribute

Project Planning and Management

• Responsible for delivering and managing Goal Attainment Scaling endpoint implementation in Phase 1–4 clinical trials and qualitative research studies.

• Develop integrated study management plans with the core project team.

• Lead and execute project kick-off and closeout tasks.

• Responsible for executing new projects per contract while optimizing speed, quality, and cost of delivery and ensuring consistent use of study tools and compliance with standard processes, policies, and procedures.

• Monitor progress against the contract and proactively prepare/present project information to stakeholders internally and externally.

Team Collaboration and Client Interaction

• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.

• May serve as primary or backup project contact with clients and would then own the relationship with the project’s key client contacts and communicate/collaborate with business development, as necessary.

• Prepare and lead internal and external meetings addressing project progress, deliverables, scope, and concerns.

• May represent Ardea Outcomes at client-facing or other events.

Operational and Financial Responsibilities

• Identify and mitigate risks proactively to ensure smooth project delivery.

• Achieve project quality by identifying quality risks and issues, responding to issues raised by the project team and sub-team members, and planning/implementing appropriate corrective and preventative action plans.

• Manage project budgets, including oversight of Change Orders, invoice preparation, and utilization tracking.

• Develop and manage comprehensive project plans, ensuring adherence to timelines and budgets.

• Ensure compliance with all company SOPs and regulatory standards throughout project execution.

• Responsible for identifying and managing resources and vendor-related activities as per project requirements.

• Provide input to managers on their project team members’ performance relative to project tasks.

What Will Help You Be Successful

• Bachelor’s degree in business, scientific, or a technical discipline.

• 5 years of prior relevant experience or equivalent combination of education, training, and experience.

• 2+ years of prior project management experience and experience in clinical operations is preferred. 

• Project Management Professional (PMP) certification is an asset.

• Knowledge of clinical trial conduct and skill in applying clinical research regulatory requirements.

• Excellent decision-making ability, clarifying disparate information to inform actions and drive results.
• Strong project planning, time management, and prioritization skills.
• Ability to organize resources needed to accomplish tasks, set objectives, and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Ability to assess the inherent risks of a situation and their potential impact on a project.
• Good understanding of project financials, including experience managing budgets, scope obligations, and implications.
• Excellent software and computer skills, including Google Workspace and MS Office applications. Excellent working knowledge of project management software (Monday.com, MS Project).
• 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 may be 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.

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