Principal Journey Manager, Experience Researcher
Autodesk
Manager, Clinical Monitoring
ResearchEd
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇨🇦 Canada
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Responsible for the oversight and performance of Clinical Monitoring staff in accordance with internal Key Performance Indicators (KPIs).
- Lead, manage, and motivate a team of Clinical Monitoring staff to a standard consistent with Catalyst’s values and overall focus on quality.
- Develop evaluation processes, perform gap analysis, and ensure all clinical staff are properly trained to perform their duties consistent with Catalyst’s quality standards.
- Work in collaboration with Clinical Monitoring Leadership to define department targets for Clinical Monitoring staff and ensure proper monitoring expectations.
- Participate in resource management, including by not limited to Clinical Monitoring staff resourcing to projects, participation in interviewing and hiring decisions and review of utilization and billing practices to ensure resource alignment with project budgets.
- Support the development and maintenance of Clinical Monitoring project deliverables as needed.
- Provide support for site audits/inspections, as needed, and follow audit/inspection findings to resolution as it relates to involved Clinical Monitoring staff.
- Periodic review of Monitoring reports to ensure quality oversight as needed.
- Implement functional standards, goals, and expectations with Clinical Monitoring staff and serve as mentor.
- Ensure training of and compliance with appropriate Catalyst and/or sponsor SOPs.
- Complete Clinical Monitoring staff onboarding and offboarding as appropriate.
- Drive process improvements across Oncology line of the business.
Requirements
- 2+ years of management or oversight within pharmaceutical or CRO industry;
- 1-2 years of Lead CRA/Clinical Trial Manager experience in the pharmaceutical or CRO industry;
- 4+ years of CRA experience in the pharmaceutical or CRO industry
- Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
- Proficient with Microsoft Office Suite.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Good judgement with the ability to make timely and sound decisions.
- Ability to travel up to 25%.
Benefits
- Ability to work remotely and manage a remote team
- Employee may be office or home based with regular business travel
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical MonitoringLead CRAClinical Trial ManagerCRA experiencedrug development processFDA regulationsICH GCP guidelinesgap analysisprocess improvementsresource management
Soft skills
leadershipcommunicationpresentationorganizationalproblem-solvinganalyticalprioritizationflexibilityinterpersonaldecision-making
