[Hiring] Manager, Monitoring & Site Management @Alimentiv

Role Description

Responsible to plan, manage, organize, evaluate and/or report on the day delivery of the Clinical Monitoring unit (Clinical Operations Leads).

• Policy and process development and improvement
• Product quality, site and compliance monitoring
• Staff resource planning
• Staff and contractor performance management

Provide support, expertise and represent project and clinical monitoring teams with sponsors/researchers throughout the project life cycle.

Ensure all team members, including third party providers, deliver high quality, timely service and maintain service delivery processes in accordance with corporate and industry best practices and that meet all regulatory requirements and guidelines.

Project Planning

• Identify, develop, plan for, monitor, approve and/or report on project specific processes and services related to:
• Site selection
• Clinical monitoring
• ICH-GCP compliance issue resolution
• Global project harmonization including SOP and QS document maintenance
• Periodic site visits
• Collaborating with IT support to meet sponsor requirements on a timely basis

Customer Service Delivery

• Represent and support the Clinical Monitoring teams with internal partners and external Sponsors
• Identify areas of improvement and address sponsor/site concerns
• Integrate new technologies and processes
• Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded

Team Management and Engagement

• Manage members of the Clinical Monitoring teams
• Ensure functional areas are adequately staffed with qualified personnel
• Provide ongoing support to staff in the areas of:
• Work allocation
• Resource planning
• Training and development
• Technology
• Process development
• Expense management
• Employee engagement
• Performance management (staff role development, evaluations, performance improvement and lost time management)

Third Party Contract Management

• Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services
• Conduct needs assessment, recruitment, and contract negotiations
• Ensure Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management
• Maintain corporate, industry and regulatory service level guidelines and regulations

Product/Service Delivery Support

• Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring
• Support performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors

Qualifications

• College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation)
• Minimum of 4-6 years related experience + substantial ongoing training
• Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues
• Ability to work in a remote global capacity
• Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP
• Team player with a customer service approach and solution-oriented mindset
• Demonstrated leadership skills
• Strong verbal, written, and organizational skills
• Ability to handle multiple tasks to meet deadlines in a dynamic environment

Working Conditions

• Home-based
• Salary: $110,500 - $174,000 a year + bonus

Phishing Scam Warning

Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.

AI Tools Usage

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.