Director, Monitoring & Site Management

Alimentiv

5d•Remote

About The Position

Alimentiv is a global CRO focused on advancing therapies for gastrointestinal diseases. This role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. The role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance. The individual will partner closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, serving as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.

Requirements

College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation)
A minimum of 4-6 years related experience + substantial on-going training.
Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting.
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 that has a customer service approach and is solution oriented.
Demonstrated leadership skills
Strong verbal, written, and organizational skills.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Responsibilities

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, and global project harmonization including SOP and QS document maintenance, periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis.
Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, to address sponsor/site concerns and to integrate new technologies and processes.
Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded.
Manage members of the Clinical Monitoring teams, ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to staff in the areas of work allocation, resource planning, training and development, technology, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management).
Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained.
Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors.