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Study Start-Up Specialist/Site Activation Partner - FSP
Parexel —Ontario
- English
- Bachelor's
Manager, Project Planner
Parexel —Ontario
- Full-time
- PMP
- Microsoft Office
- Master's degree
Clinical Study Administrator
Parexel —Ontario
- Hybrid work
- English
- Administrative experience
- High school diploma or GED
Local Study Associate Director - FSP
Parexel —Ontario
- English
- Finance
- Project management
2d
Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
Parexel —Ontario
- Communication skills
12d
Investigator Contracts Lead/Site Contracts Lead
Parexel —Ontario
- Doctoral degree
- English
- Presentation skills
Senior Clinical Research Associate/CRA - FSP
Parexel —Ontario
- Nursing
- English
- Bachelor's
Clinical Operations Manager-FSP
Parexel —Ontario
- Hybrid work
- English
- Travel
- Organizational skills
Study Start Up Project Manager - FSP
Parexel —Ontario
- Doctoral degree
- English
- Master's degree
Clinical Research Manager- FSP
Parexel —Ontario
- Medicine
- Doctoral degree
- English
Site Contracts Lead - FSP
Parexel —Ontario
- Doctoral degree
- English
- Presentation skills
Study Start Up Project Manager II- FSP
Parexel —Ontario
- Management
- Doctoral degree
- English
Medical Director, Endocrinology
Parexel —Ontario
- Medicine
- English
- Travel
3d

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Study Start-Up Specialist/Site Activation Partner - FSP

Parexel -
Ontario

Apply Now

Job details

Qualifications

English
Bachelor's

Full job description

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to:

Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation

Provide support to resolve issues or concerns and timely escalation of Site issues where applicable

Manage and coordinate with other supporting roles to ensure timely site activation and operational activities

Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required

Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines

Identify and resolve investigator site issues

Experience required for this role:

School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred

Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.

Experience working in the pharmaceutical industry/or CRO is an asset

Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations

Must be fluent in Local language and in English. Multi-language capability is an asset

#LI-LO1

#LI-REMOTE

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Refine Your Search

Study Start-Up Specialist/Site Activation Partner - FSP

Manager, Project Planner

Clinical Study Administrator

Local Study Associate Director - FSP

Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines

Investigator Contracts Lead/Site Contracts Lead

Senior Clinical Research Associate/CRA - FSP

Clinical Operations Manager-FSP

Study Start Up Project Manager - FSP

Clinical Research Manager- FSP

Site Contracts Lead - FSP

Study Start Up Project Manager II- FSP

Medical Director, Endocrinology

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