Job Description

Job Number:

J1022-0692

Job Title:

Lead Medical Reviewer, Clinical Research

Job Location:

5000, rue Belanger Est

Posting Date:

October 11, 2022

Job Category:

Management

Job Type:

Full time

Shift:

Jour

Lead Medical Reviewer, Clinical Research

Montreal Health Innovations Coordinator Center

Full Time

The Montreal Health Innovations Coordinating Center (MHICC) is a full service contract research organization targeted on multicenter and multinational clinical trials. We provide services to the academic community and to the pharmaceutical, biotechnology and medical device industries. Our main goal is to establish a partnership with our customers to ensure a successful implementation of their project while respecting the scope of work, budget, timelines and highest standards of quality.

RESPONSIBILITIES

-Leads, manages and directs the medical reviewer team within the Clinical Research department

-Provides expertise, leadership and guidance for the safety reporting and review of medical reports in clinical studies, both internally and externally

-Provides expertise and guidance for clinical and medical documents writing

-Implements, in collaboration with the MHICC upper management and the Senior Director Operations, appropriate systems and processes

-Develops, implements and maintains technical tools needed to ensure efficiency and, effectiveness, in data collection activities, procedures, systems and technologies

-Develops, revises, implements and provides training on the standard operating procedures for the medical reviewer team within the Clinical Research department

-Ensures that the medical reviewer team maintains current knowledge of scientific and regulatory developments

-Provides mentoring, coaching, and development of the medical reviewer team within the Clinical Research department

-Participates, in collaboration with the MHICC upper management, in the evaluation and hiring of new candidates and participates in critical managerial decisions (hiring, firing, etc.)

-Develops annual objectives for the medical reviewer team within the Clinical Research department and ensures that they are in accordance with those provided by MHICC upper management

-Creates and monitors individual development plans and completes performance evaluations for subordinates

-Ensures the administration and efficiency of the medical reviewer team within the Clinical Research department in order to achieve the MHICC and MHI objectives

-Assists the Senior Director Operations in the preparation and revisions of requests for proposals, proposals, and budgets

-Develops, in collaboration with the MHICC Leads, the clinical study protocols

-Assists the Senior Director Operations with the establishment of a project management plan that includes timelines and deliverables for each clinical study

-Ensures the medical reviewer team within the Clinical Research department is working in line with the clinical study timelines, scope of work, budget, client expectations and contractual obligations

-Reports any major clinical study issue to the Senior Director Operations and MHICC upper management that may have an impact on the clinical study timelines, scope of work, budget, client expectations and contractual obligations

-Acts as the primary contact for the medical reviewer team for resolving complex issues

-Collaborates cross-functionally and leads the discussion on safety management topics, requirements and issues

-Creates and presents regular progress reports, including achievements and potential challenges and/or risks for MHICC upper management

-Writes and/or reviews Data Safety Monitoring Board and Clinical Event Committee Charters, and Medical Review Plans

-Supervises and reviews the medical review and safety management records

-Develops, writes and/or reviews the draft clinical study reports

-Submits safety annual reports to the regulatory authorities

-Assists in the interpretation and writing of results for abstracts, presentations, manuscripts, etc.

-Assists in the preparation of an audit or regulatory inspection

-Performs the responsibilities of a medical reviewer

-Participates in sponsor meetings

-Participates in executive committee meetings

REQUIREMENTS

-Doctor of medicine or equivalent

-Excellent knowledge of clinical research methodology and solid understanding of clinical studies, ICH, GCP, and other applicable regulatory requirements

-Strong leadership, project management and interpersonal skills.

-Must have strong analytical and problem-solving skills.

-Prioritize effectively

-Bilingual (French/English)

-Computer literacy and proficient in Microsoft Office including Excel

-Selected candidates must demonstrate excellent organization, communication and management skills and leadership skills

WORK CONDITIONS

-35 hours weekly base

-Pre-approved overtime paid

-Flexible work schedule for work-family balance

-Hybrid model (working from home and office)

-4 weeks' vacation after one year

-13 statutory holidays

-Defined retirement benefits

-Group insurance

-9.6 day off sick days

The Montreal Heart Institute offers a wide range of benefits aimed at employees' health, well-being and quality of life at work, including free access to the EPIC Centre, Recharjme cabins and silence rooms, as well as various other benefits.

TO SUBMIT YOUR APPLICATION

-Final date to apply: November 15, 2022

-Send your application to the following address:

-Please indicate the job title for which you are submitting your application