Minimum of one to three years of related work experience in clinical research., A three-year College Advance Diploma or Degree in a relevant field, preferably in Health Sciences or Clinical Research., Experience working at the site level in clinical research, such as a Clinical Research Coordinator or Study Manager., Strong communication skills, self-motivation, and attention to detail..
Key responsibilities:
Manage and monitor regional clinical research projects from start to finish.
Coordinate with cross-functional teams to ensure regulatory compliance and project quality.
Act as the primary liaison with clients and sponsors, providing project updates and resolving issues.
Ensure proper documentation, data management, and adherence to project timelines.
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From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.
As the primary sponsor liaison and advocate, the Clinical Project Manager will plan, execute, manage and monitor regional, single modality or therapeutic area clinical research projects. Utilizing existing templates, processes and programs as a guide, he or she will adaptdevelop, implement, monitor and be accountable for project protocols, operational plans, risk management, resources, project toolsmaterials, documents and timelines. The successful candidate will be managing the day to day activities and performance of a multidisciplinary project team, ensuring all decisions align with corporate, industry, sponsor and regulatory requirements.
Project Management
Manage the planning, execution, progress and completion of assigned clinical research projects.
Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.
Maintain operational, financial and regulatory integrity and safety.
Develop andor participate in the development of project communications, training, regulatory submissions andor audits and selection of third party vendors as required.
Documents and Tools
Manage a crossfunctional team to ensure the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions.
Prepare investigator updates and other project related reports as required to support the proper conduct and execution throughout the life cycle of assigned projects.
Project Team Performance
Identify, assign and monitor the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safetyadverse event management, document management, statistical analysis andor final report writing and publications.
Ensure task completion performance meets or exceeds quality standards and sponsorclient, project and regulatory expectations and guidelines.
ClientSponsor Support
Act as primary liaison throughout the project life cycle ensuring clientsponsor expectations are appropriately managed by addressing and resolving queriesissues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsorclient with project status and update reports.
Qualifications
Applicants should have a minimum of one to three years of related work experience with ongoing training, and a threeyear College Advance DiplomaDegree in a relevant field of study, preferable in (Health) Sciences or Clinical Research.
The successful candidate must exhibit the following skills: selfmotivation with strong communication skills and a commitment to achieving positive results.
Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
Experience working in clinical research at the site level (e.g., as a Clinical Research Coordinator or Clinical Study Manager).
Direct project management experience in clinical trials or imaging studies.
Familiarity with sitelevel operations in clinical research settings.
Experience in the gastrointestinal (GI) therapeutic area is a plus.
Minimum 2–4 years of relevant industry experience
Working Conditions
Home Based
Occasional travel
*Accommodations for job applicants with disabilities are available upon request