Overview
Clinical Research Manager Jobs in Montréal – Quebec at Parexel
Title: Clinical Research Manager
Company: Parexel
Location: Montréal – Quebec
Category: Research/Development
PXL is seeking a
Clinical Research
Manager (CRM) in Canada for one of our large FSP clients! This is a remote position with some travel. Oncology experience is preferred! Position
Purpose:
The
Clinical Research
Manager (CRM) is responsible for the following:
Primarily accountable for end-to-end performance and
project management
for assigned protocols in a country in compliance with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, could be responsible for several countries in a cluster.
Organizational Relationships:
Reports to Parexel
-assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
Collaborates internally with (Headquarters) HQ functions, regional and local operations, European Union (EU) Clinical development, Pharmacovigilance, Global Medical Affairs (GMA) to align on key issues/decisions across the trials. Global Human Health (GHH) to be consulted as needed.
Primary Responsibilities:
Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).Responsible for
project management
of the assigned studies:
Proactively plans/drives/tracks execution and performance of deliverables/timelines/resultsto meet country commitments from feasibility and site selection, recruitment, execution and closeout.
Accountable for performance for assigned protocols in country in compliance with International Committee on Harmonization (ICH) /Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally
Performs
quality control
visits as required.
Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and /or functional vendor and internal management as needed.
Leads local study teams to high performance:
Trains in the protocol for other local roles.
Collaborates with and supports
Clinical Research
Associates (CRAs) as protocol expert.
Coordinates activities across the different local country roles ensuring a strong
collaboration
(including the Clinical Trial Coordinator (CTC), CRAs, and Clinical Operations Manager (COM).Responsible for creating and executing a local risk management plan for assigned studies.
Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File(eTMF) and other key systems in assigned studies.
Escalates as needed different challenges and issues to Therapeutic Area (TA) Director /
Clinical Research
Director (CRD) / Clinical Quality Management (CQM) and or Clinical Trial team (CTT) (as appropriate).Identifies and shares best practices across clinical trials, countries, clusters. Responsible for
collaboration
with functional outsourcing vendors, investigators, other external partners in assigned studies.
Country POC for programmatically outsourced trials for assigned protocols.
As a customer-facing role, this posi…
