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 adapt/develop, implement, monitor and be accountable
for project protocols, operational plans, risk management, resources, project
tools/materials, 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.
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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 and/or participate in the development of project communications,
training, regulatory submissions and/or audits and selection of third party
vendors as required.
Documents and Tools
- Manage a cross-functional 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 safety/adverse event management, document
management, statistical analysis and/or final report writing and
publications.
- Ensure task completion performance meets or exceeds quality standards and
sponsor/client, project and regulatory expectations and guidelines.
Client/Sponsor Support
- Act as primary liaison throughout the project life cycle ensuring
client/sponsor expectations are appropriately managed by addressing and
resolving queries/issues, 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 sponsor/client 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 three-year College Advance
Diploma/Degree in a relevant field of study, preferable in (Health) Sciences
or Clinical Research.
- The successful candidate must exhibit the following skills: self-motivation
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.
- Ability to engage in continuous learning and self-development.
- Ability to continually foster teamwork.
Working Conditions
- Home Based
- Occasional travel
- *Accommodations for job applicants with disabilities are available upon
request
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$82,000 - $137,000 a year
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