Study Manager, Clinical Trials

Study Manager, Clinical Trials

Title: Project Manager, Clinical Trials
Work Location: Downtown, Montreal, QC (hybrid)
Permanent Position, Full-time

Job Summary:
Responsible for the overall management of the clinical study. Primary contact for all communications. Responsible for the setup, conduct, and closure of the study in relation to other departments.

Responsibilities:
Customer (internal and external) satisfaction: ensuring project success
• Coordinating communication with all parties involved in the study.
• Monitoring study reports and progress with other departments to adjust study communication accordingly.
• Facilitating actions to be taken in all aspects (sponsor decisions, communication, bottleneck resolution).

Project Management:
• Handling standardized operations and delivering the project on time and with good quality.
• Project management coordination: planning and implementation, tracking of deliverables, and budgeting.
• Monitoring and reporting client complaints, bottlenecks, or scope changes in terms of risk analysis and impact.
• Responsible for study specifications and documentation.

Quality Assurance:
• Adherence to the quality assurance system.
• Supporting continuous improvement by appropriately reporting deviations and bottlenecks.
• Maintaining KPIs and dashboard with the STM lead to track performance in studies.
• Supporting client audits.

Required Skills:
• Minimum 3 years in clinical project management or CRA.
• Understanding of the clinical research ecosystem and its challenges: Keeping up-to-date with the latest technologies and advancements in the field of clinical research.
• Mastery of fundamental project management principles: In-depth understanding of project management principles. This includes planning, organizing, budgeting, risk management, resource management, and time management.
• Knowledge of regulations: Understanding local and international regulations.
• Knowledge of IT tools: Proficiency in project management, data collection, and statistical analysis tools is necessary to facilitate study management.

Required Competencies:
• Budget management: Ability to manage the project budget, monitoring expenses, forecasting costs, and ensuring resources are used efficiently.
• Time management: Meeting project deadlines, data collection, and result analysis.
• Team management and leadership: Supervising and motivating study stakeholders.
• Data management: Ability to analyze data effectively and securely to ensure result integrity.
• Ethics and integrity: Adherence to ethical principles of clinical research.
• Risk management: Identifying, evaluating, and mitigating risks associated with the clinical study.
• Problem-solving skills: Ability to quickly resolve issues and obstacles to ensure the smooth progress of the study.
• Communication: Effective communication, presenting study results to stakeholders, and collaborating with other professionals.
• Adaptability: Rapid adaptation to new circumstances is important.
• Leadership: Guiding the team and inspiring confidence.
• Stress management: Crucial for handling the pressure of complex clinical research projects.
• Teamwork: Collaboration with a multidisciplinary team is essential.
• Perseverance: Necessary for overcoming obstacles in clinical research.
• Results orientation: Focused on achieving study objectives.
• Honesty and transparency: Important in communication with the research team, stakeholders, and patients.

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