Remote Study Start-Up Project Manager - Canada
- Canada
Full-time
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Job details
- Job type
- Full-time
- Apply by
- Experience
- At least 5 years of study start-up Lead/Manager experience at a CRO;
- Posting language
- English
- Posted
Original job description
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Study Start-Up Project Manager to join our Clinical Operations team in Canada. This position plays a key role in the clinical trial management process at Medpace. With our continued growth in Canada, we are looking for proactive, positive, and self-motivated individuals with a shared commitment to quality to join our supportive and dynamic team.
Responsibilities
- Efficiently manage and successfully execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Serve as a Sponsor point of contact for start-up and regulatory submissions items;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits
Qualifications
- Bachelor’s degree in a science or health-related field;
- At least 5 years of study start-up Lead/Manager experience at a CRO;
- Study start-up experience with Health Canada and Ethics submissions;
- Knowledge of ICH guidelines and applicable local regulations; and
- Proficiency in English and French is a plus.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
- Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
- Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
- Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
- Office based environment with on-site mentors
- Defined career paths with clear advancement opportunities
- Industry renowned onboarding and training programs designed to accelerate professional development
- Ongoing training and continuous learning opportunities throughout your career
- An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
- Competitive compensation programs that recognize and reward performance
- Comprehensive health, wellness, retirement, and PTO benefits
- Office based culture with occasional WFH that provides flexibility for eligible positions after training
- Company-sponsored social events
Please note benefits may vary based on country.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
More about this job
Responsibilities
The Project Manager will efficiently manage and execute all aspects of global study start-up and perform quality checks on submission and site documents. They will also serve as a primary sponsor contact and present during bid defenses and audits.
Requirements
Candidates must hold a bachelor's degree in a science or health-related field and possess at least 5 years of study start-up experience at a CRO. Proficiency in ICH guidelines and experience with Health Canada and Ethics submissions are required.
Skills
- Clinical trial management
- Study start-up
- Regulatory submissions
- Quality checks
- Informed consent forms
- Project management
- ICH guidelines
- Health Canada submissions
- Ethics submissions
- Bid defenses
- Clinical operations
Benefits
- Competitive compensation programs
- Health benefits
- Wellness benefits
- Retirement benefits
- Paid time off
- On-site mentors
- Training programs
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Management & Leadership
- Science & Research
Keywords
- Clinical operations
- Study start-up
- Project management
- Clinical trials
- Medpace
- CRO
- Regulatory submissions
- Health Canada
- Ethics submissions
- ICH guidelines
- Informed consent
- Bid defenses
- Biotechnology
- Pharmaceutical
- Medical device
- Clinical research
- Oncology
- Cardiology
- Metabolic
- Endocrinology
- Central nervous system
- Anti-viral
- Anti-infective