Clinical Data Manager
About Ardea Outcomes
Ardea Outcomes is a global purpose-led contract research organization (CRO) focused on improving health outcomes through patient-centric research. Our services and digital products have been honed over 20+ years to translate the patient voice into actionable evidence using Goal Attainment Scaling (GAS). Using GAS as a patient experience outcome, we move the conversation from “what’s the matter” to “what matters most” for patients and caregivers in clinical development.
Based in Nova Scotia, our culture reflects an East Coast Canadian ethos rooted in hard work and collegiality. Our team comprises collaborative, entrepreneurial individuals passionate about driving meaningful solutions to capture the patient experience in clinical development. Similar to our mission, we believe in putting our people at the core of everything we do. We strive to produce world-class science led by our core values of social impact, scientific rigour, teamwork, and partnership. We choose people and partners who share this mindset because, although our work is clinical, it’s personal.
Ardea Outcomes is on a path to revolutionize the clinical drug development industry and fundamentally re-engineer patient care. We are looking for a Clinical Data Manager to lead clinical data management activities across multiple clinical studies. Reporting to the Research Manager, the clinical data manager will lead data management activities from study startup to database close, working collaboratively with the Ardea team and our research partners throughout the study.
This role contributes to the overall success of a trial by ensuring data collection, storage, cleaning, transfer, and reporting processes are followed as defined in plans and study protocol. Since good clinical practice is critical for this function, this role will manage quality control and governance processes concerning all data management-related aspects of the study throughout the trial. As Ardea is a growing company, the clinical data manager will be given opportunities to help shape and enhance our current clinical data management processes.
You love solving problems and don’t let little details slip through the cracks. You tend to thrive in a dynamic environment and are often the person taking the initiative to improve or create new processes. You are an excellent communicator and are willing to help your colleagues when needed. You are curious about the clinical research industry and how Ardea Outcomes is helping to elevate the patient voice in global clinical trials.
What You’ll Be Doing:
In this role, your duties will include, but not be limited to:
Data Management Planning:
- Serve as a key subject matter expert on topics related to data management activities
- Prepare standard plans to support the clinical trial.
- Design the database for the clinical trial.
- Design, develop, and review Electronic Case Report Forms (eCRFs), annotations, eCRF Completion Instructions, and Validation Specifications.
- Conduct User Acceptance Testing (UAT) for data collection tools.
Data Management - Execution and Data review:
- Act as Functional Lead for Data Management
- Support study data management and data cleaning processes on an ongoing basis
- Work proactively throughout the trial to optimize the data collection, storage, and management processes.
- Liaise and manage communication with clients.
- Lead proper communication between functions and others to reconcile all data-related issues.
- Review and implement study-related protocol or data capture changes.
- Identify, mitigate, and manage risks associated with data management throughout a clinical trial.
- Proactively conduct quality checks on data to ensure data quality and integrity.
- Identify and resolve queries (data clarifications) to address inconsistent/missing data.
- Report data quality issues and solutions to the appropriate management authority to take remedial action.
Other Technical competencies:
- Formulate and execute project plans within the area of responsibility.
- Make recommendations for project processes to improve efficiency and/or effectiveness within the area of responsibility.
- Provide training and direction on electronic data capture (EDC) system, eCRF completion, and quality control processes and act as a resource to staff assigned to these projects.
- Work collaboratively and effectively to ensure sponsors’ needs and objectives are supported by consulting and providing clinical data management services.
What We Are Looking For:
- Minimum of a BA/BS in biological sciences or related disciplines in Natural Health/Life Sciences or Health Informatics.
- Clinical data management experience or an equivalent combination of education and experience.
- Experience with Clinical Data Management practices and relational database management software systems.
- Knowledge of clinical data requirements and ICH/Good Clinical Practices.
- Good understanding of CDISC SDTM/CDASH standards.
- Knowledge of MedDRA and WHODrug dictionaries.
- Proficiency in MS Windows navigation, Microsoft Office and Google Workspace.
- Effective oral, written and presenting communication skills.
- Strong project management skills.
- Ability to be flexible, adapt to change, and work independently and as part of a multidisciplinary team.
- Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
- CCDM Certification (Certified Clinical Data Manager) is an asset.
Why You’ll Love Working at Ardea:
- The full-time position will be remote. Occasional visits to our Halifax, Nova Scotia headquarters may be offered.
- 35-hour work week, with flexible hours
- Generous vacation, holiday and sick time allowances
- Learning and development opportunities
- Family health, dental and vision benefits
- Virtual and in-person social events and team-building activities
We would like to thank all applicants for their interest. Please note only those selected for an interview will be contacted.
Please visit our careers page to see more job opportunities.
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