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Remote Study Start-Up Project Manager - Canada

Role overview

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

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

Key facts

Other skills

  • Quality Assurance
  • Problem Solving
  • Communication
  • Teamwork
  • Time Management

About the company

Medpace logo

Medpace

Contract Research Organizations (CRO)

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 5,800 people across 43 countries.

Company details

Company typeLarge
IndustryContract Research Organizations (CRO)
Company size5001 - 10000

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Job description

Job Summary :

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Global Study Start-Up Lead 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.

 

Incentives can include: competitive bonus program, sign-on bonus, and equity awards.

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). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Why Medpace? :

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

 

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

 

Medpace Perks

  • Flexible work environment 
  • Competitive compensation and benefits package
    • Life and Medical Insurance
    • Voluntary Pension Plan
    • Salary set and paid in local currency (CAD)
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth

 

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

 

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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