Closing date: Will remain open until suitable candidate found
Salary:Commensurate with experience
Benefits:Health/dental plan, employee & family assistance program, retirement plan, perks
Start Date: Mar 2025
Primesite Research Solutions is an Integrative Research Organization and Site Network based out of Western Canada. We conduct phase I, II, III, IV clinical trials in various clinical areas at local hospitals and clinics. We are seeking a Research Operations Manager to join our growing site network.
The ideal candidate will have extensive experience and a proven track record in leading and managing intricate clinical trials research operations, while simultaneously fostering a successful and collaborative team environment. Exceptional organizational and project management skills are essential, with the ability to oversee multiple teams, projects, budgets, and timelines concurrently. The successful candidate will possess outstanding communication skills and a comprehensive understanding of clinical trials regulations and industry requirements.
The Research Operations Manager will work closely with Research Coordinators, Research Assistants, biopharma companies, and other research support staff and medical professionals, including physicians, ensuring the seamless execution of day-to-day site operations. This role involves a strong emphasis on project management oversight and working collaboratively with the research team to provide support, manage staff workload distribution, and offer constructive guidance. The Site Operations Manager will act as a key liaison between the site team and the General Manager.
Key Responsibilities:
Project Management
- Oversee multiple clinical trials projects, ensuring they are completed on time, within budget, and to the highest quality standards.
- Develop comprehensive project plans, setting realistic timelines, allocating resources effectively, and identifying potential risks and mitigation strategies.
- Track project progress, monitoring milestones, deliverables, and dependencies, and taking corrective action as needed to maintain project momentum.
- Develop and implement relevant site and project policies and procedures as needed, ensuring consistency and standardization across operations.
- Lead and coordinate diverse research teams, fostering collaboration, communication, and a shared sense of purpose.
- Facilitate effective communication between project stakeholders, providing regular updates on project status and addressing any concerns or issues promptly.
Team Management
- Oversee daily site operations, ensuring efficient and effective workflow and resource utilization.
- Assess workload and allocate resources strategically, balancing priorities and optimizing productivity.
- Provide inspirational leadership and direction to research teams, motivating and empowering team members to achieve their full potential.
- Conduct regular performance reviews, providing constructive feedback, recognizing accomplishments, and identifying areas for development.
- Carry-out and enforce company policies and procedures, ensuring a safe, respectful, and productive work environment.
- Administer disciplinary action when necessary, addressing performance issues and policy violations in a fair and consistent manner.
- Assess staffing needs, participate in recruitment planning and hiring processes, ensuring adequate staffing levels and skill mix, attracting and retaining top talent.
- Foster a positive and inclusive team culture, promoting teamwork, collaboration, and mutual respect.
Quality Control Management
- Champion quality assurance and quality control initiatives across all research studies, ensuring adherence to the highest standards.
- Develop and implement robust quality control procedures as needed.
- Conduct regular quality control checks, identifying and addressing any quality issues or deviations promptly.
- Ensure compliance with all relevant clinical trial regulations, guidelines, and industry best practices.
- Stay abreast of emerging trends and developments in quality management, incorporating best practices into research operations.
Skills Required for Success:
- Relevant Experience: Prior experience in clinical research or a related field is highly desirable.
- Educational Background: A Bachelor's or Master's degree in a relevant discipline, such as life sciences, healthcare, or business administration, is preferred.
- Professional Certifications: Project Management Professional (PMP) or other relevant certifications are a plus.
- Exceptional Project Management Skills: Demonstrated ability to strategically plan, meticulously organize, and efficiently execute projects from initiation to closure, ensuring alignment with objectives and stakeholder expectations.
- Superior Time Management and Organizational Skills: Proven capacity to effectively prioritize tasks, allocate resources judiciously, and manage multiple projects concurrently, consistently meeting deadlines and achieving milestones within budget constraints.
- Strong Analytical and Problem-Solving Skills: Adept at critical thinking and data-driven decision-making, capable of identifying potential challenges, proactively mitigating risks, and implementing effective solutions to ensure project success.
- Excellent Communication and Interpersonal Skills: Exceptional ability to foster and maintain positive relationships with stakeholders, team members, and cross-functional partners, promoting collaboration, clear communication, and timely information exchange.
- Leadership and Team Building: Proven capacity to inspire and motivate teams, delegate responsibilities effectively, and cultivate a positive and productive work environment that fosters innovation, accountability, and high performance.
- Proficient Knowledge of Clinical Trial Regulations and Guidelines: Comprehensive understanding of relevant regulations, guidelines, and ethical principles governing clinical research, ensuring compliance and maintaining the highest standards of data integrity and patient safety.
- Experience with Quality Assurance and Quality Control Processes: Demonstrated ability to implement and oversee robust quality management systems, ensuring adherence to protocols, data accuracy, and compliance with regulatory requirements.
- Continuous Learning and Adaptability: Committed to staying abreast of emerging trends, best practices, and technological advancements in project management and clinical research, embracing innovation and adapting strategies to optimize outcomes.
- Financial Acumen: Skilled in budgeting, financial forecasting, and resource allocation, ensuring cost-effectiveness and fiscal responsibility throughout the project lifecycle.
- Proficiency in Project Management Tools and Software: Expertise in utilizing project management tools and software to streamline processes, track progress, and facilitate effective collaboration among team members.