Talent.com
Parexel
Country Study Operations Manager/Clinical Trial Manager - FSPParexel • Remote, Ontario, Canada
Country Study Operations Manager/Clinical Trial Manager - FSP

Country Study Operations Manager/Clinical Trial Manager - FSP

Parexel • Remote, Ontario, Canada
30+ days ago
Job type
  • Full-time
  • Remote
Job description

When our values align, there's no limit to what we can achieve.

The Study Operations Manager has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

  • Serves as leader of the local study team on one or more studies
  • Provides back up to or assumes the responsibilities of the GSM as needed
  • Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
  • May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable
  • Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
  • Provides country level input on startup and recruitment milestones during planning
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
  • Accountable for resolution of site activation escalations to study teams including offering options for mitigation
  • Fully responsible and accountable for, as designated by the GSM:Regional, country, and study level implementation of startup and site activation plansRegional, country and study level recruitment strategyDevelopment of study level plansCommunication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plansStudy and/or country vendor management and oversight including follow up and coordination of vendor deliverablesAssurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.

Requirements:

  • Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
  • Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
  • A scientific or technical degree is preferred

#LI-LO1

Create a job alert for this search

Country Study Operations Manager/Clinical Trial Manager - FSP • Remote, Ontario, Canada

Similar jobs

Global Campaign Manager

OpenTextsouthwestern ontario, on, Canada
Full-time

Opentext - The Information Company.OpenText is a global leader in information management, where innovation, creativity, and collaboration are the key components of our corporate culture.As a member... Show more

 • Promoted

Clinical Practice Leader Wound & Skin Program

Humber River HealthON, CA
Full-time +2

Clinical Practice Leader Wound & Skin Program.Clinical Practice Leader Wound & Skin Program.Clinical Practice Leader Wound & Skin Program.Be among the first 25 applicants.Clinical Practice Leader W... Show more

 • Promoted

Manager, Individual Wealth Operations

EquitableSouthwestern Ontario, ON, CA
Permanent

At Equitable, we believe work should be a place where you feel supported, inspired, and empowered to grow.In our caring and collaborative environment, your curiosity is encouraged, your passion is ... Show more

 • Promoted

Territory Manager

Professional StaffingON, CA
Full-time

VP Sales & Marketing | Expertise in strategic recruitment matching talent and clients in the Industrial/ Corporate Sectors.Our client specializing in material handling equipment across North Americ... Show more

 • Promoted

Manager, Commodity Risk Management

Litherland & Co.ON, CA
Full-time

Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Litherland & Co.Executive Search Consultant, Agribusiness.Our clien... Show more

 • Promoted

Senior Product Operations Manager, Kinaxis

KinaxisSouthwestern Ontario, ON, CA
Full-time

Lead impactful supply chain initiatives in the role of Senior Program Manager at Kinaxis, focusing on product operations.This hybrid role requires strong leadership and strategic execution skills.A... Show more

 • Promoted

Marketing Operations Manager

Magnet ForensicsSouthwestern Ontario, ON, CA
Full-time

The Marketing team is responsible for developing and leading programs at all stages of the marketing funnel to drive demand and create opportunities for our global sales team.By leveraging AI and a... Show more

 • Promoted

Product Manager Clinical Imaging Solutions

Canon Medical Informatics, Inc.Southwestern Ontario, ON, CA
Full-time

Optimize clinical imaging workflows as a Senior Product Manager focused on end-to-end improvements.Enhance decision-making processes in radiology, oncology, and surgical settings.You will be respon... Show more

 • Promoted

Manager of Informatics in Healthcare

responsivegroupSouthwestern Ontario, ON, CA
Full-time

Exciting opportunity as the Manager of Clinical Informatics, focusing on RAI-MDS 2.This position is critical for compliance and data integrity.Reporting directly to the Director of Care, this manag... Show more

 • Promoted

Senior Program Manager, Product Operations(Saas Supply Chain Platform)

KinaxisSouthwestern Ontario, ON, CA
Full-time

Are you looking to join an innovative, market‑leading company where you can truly elevate your career? At Kinaxis we are serious about culture, we are serious about technology, we are serious about... Show more

 • Promoted

Senior Solution Consultant, Operation Research Lead (Supply Chain Saas Solutions)

KinaxisSouthwestern Ontario, ON, CA
Full-time

Are you looking to join an innovative, market-leading company where you can truly elevate your career? At Kinaxis we are serious about culture, we are serious about technology, we are serious about... Show more

 • Promoted

NPI Operations Lead: Manufacturing & Launches

NDI (Northern Digital Inc.)Southwestern Ontario, ON, CA
Full-time

A leading medical technology firm in Ontario is seeking an Operations Project Manager to support New Product Introduction activities.This role requires expertise in Manufacturing Operations and Sup... Show more

 • Promoted

Sr Product Manager - Clinical Workflow

Canon Medical Informatics, Inc.Southwestern Ontario, ON, CA
Full-time

The Senior Product Manager understands clinical context deeply, owns end-to-end imaging workflow (acquisition → interpretation → downstream action), and has accountability for measurable business o... Show more

 • Promoted

Manager of Clinical-Informatics - must be an RPN

Responsive Group Inc.Southwestern Ontario, ON, CA
Full-time

How do you live in the moment?”.We are passionate about ‘Making Every Moment Matter’™.We are seeking a candidate that shares our values - a person who has a passion to make a difference, who has a ... Show more

 • Promoted

Manager of Clinical-Informatics - must be an RPN

responsivegroupSouthwestern Ontario, ON, CA
Full-time

Manager of Clinical Informatics.Reports to the Director of Care and coordinates the RAI-MDS 2.CIHI reports, ensures compliance, and provides education and mentorship to staff.Oversee informatics on... Show more

 • Promoted

Territory Manager

Lock Search GroupON, CA
Full-time

Our client, a leading global diversified pharmaceutical company, is looking for a passionate and results-driven.In this role, you will be responsible for building and establishing relationships and... Show more

 • Promoted

Growth Leader, Health Solutions & Pharmacy Strategy

Ontario Teachers Insurance Plansouthwestern ontario, on, Canada
Full-time

A leading insurance provider in Ontario is looking for a Vice President, Group Insurance Growth & Health Solutions.This role is vital in driving the organization's group insurance strategy and expa... Show more

 • Promoted

Equitable Manager, Individual Wealth Operations

EquitableSouthwestern Ontario, ON, CA
Full-time

Shape the future of Individual Wealth Operations with Equitable as a Manager.This hybrid role drives service excellence and strategic transformation in client operations.Equitable seeks an experien... Show more

 • Promoted

Operations Project Manager

NDI (Northern Digital Inc.)Southwestern Ontario, ON, CA
Full-time

AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.Every day, we help shape the future of healthcare.We design and build 3D tracking systems that equip medical devices with advanced spatial navigation... Show more

 • Promoted

Senior Budget Specialist, Clinical Research

Probity Medical Research Inc.Southwestern Ontario, ON, CA
Full-time

Senior Budget Specialist, Clinical Research.Full-time position based in Waterloo, ON, Canada.Probity Medical Research (PMR) is an administrative support company that partners with clinical research... Show more