Pharmacovigilance Jobs in Malartic, QC

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• Bilingual- English / French proficiency

Oncology experience required

Job Summary :

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor I will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).

Key Accountabilities :

Oversight of Monitoring Responsibilities and Study Conduct :

and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates / escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs) / processes

performed and documented for each subject as required

and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues

monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations

source documents and medical records

o Verifies required clinical data entered in the Case Report Form

CRF) is accurate and complete

guidance to site staff as necessary, driving query resolution to closure

within agreed timelines

o Utilizes available hardware and software to support the effective

conduct of the clinical study data review and capture

reviews storage and security

according to the protocol and verifies issues or risks associated with

blinded or randomized information related to IP

procedures to ensure IP is appropriately (re)labelled, imported and

released and returned

o Manages reporting of identified issues and manages follow up to

resolution

communication logs, and other required project documents as per SOPs

and CMP and SMP

appropriately delegated and trained

ongoing status and assigned action items to resolution

o For assigned activities, understands project scope, budgets, and

timelines; manages site level activities and communication to

ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets

pages, outstanding data queries, timelines for database locks

newly added or removed site staff are documented appropriately and the

log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)

queries

and non-clinical) continue to be adequate to conduct the trial and with

their expiry dates (as applicable)

Log, Screening and Enrollment Log, Signature Sheet and Delegation of

Duties Log, Subject Identification Code List, IP Accountability Log)

Collaboration :

liaison with site personnel

meetings

inclusive of client representation, as applicable) and attends clinical

training sessions according to the project specific requirements

Process, Standards, and Oversight :

standards and supports preparation for audit and required follow up actions

Skills :

Knowledge and Experience :

Education :