Clinical Trial Manager II / Gestionnaire d'essais cliniques II, Early Phase (Can

Description

Clinical Trial Manager, Early Phase and Translational Research (CTM I, EPTR), Canada - North America

The Clinical Trial Manager II, Early Phase and Translational Research (CTM II, EPTR) is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables of Early Phase clinical trials.

This includes but is not limited to clinical research associate (CRA) training, identification of quality issues related to site performance and clinical monitoring activities, establishing action plans to address any concerns, as well as ensuring timelines are met.

The CTM II, EPTR may also perform project management responsibilities on select trials with limited Sponsor involvement (eg, observational, IIS, etc).

This role will be perfect for you if

You enjoy working with a Canadian-owned mid-sized CRO where you can build professional relationships with your colleagues at all levels

You bring previous experience in managing the clinical monitoring portion of clinical projects

Dermatology and rheumatology are therapeutic areas you enjoy or want to learn more about

RESPONSIBILITIES

The Clinical Trial Manager II, Early Phase and Translational Research:

Supports the PM, EPTR to oversee clinical monitoring and ensure that activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with the Monitoring Plan, the study budget, applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;

Identifies risks, quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;

May serve as a point of contact for CRAs and Lead CRAs for assigned projects;

Provides mentoring/oversight of CRAs and Lead CRAs;

Oversees site visit report review for assigned projects and tracks site visit report metrics to ensure compliance;

Contributes to the development of the Clinical Monitoring Plan and project-specific training for the CRAs and sites (SQV, SIV conduct and COV training material and conduct);

Develops the annotated site visit reports and monitoring tools;

Conducts quality control visits with CRAs;

Contributes to CRA meetings content;

Performs co-monitoring visits with CRAs;

Aid in development and maintenance of Clinical Operations specific key project performance indicators.

May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs), requests for information (RFIs)).

The CTM II, EPTR may also assume the following responsibilities of primary contact for Sponsor on select studies (eg, observational, IIS):

Manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinates tasks and deliverables from all functional departments involved in the project;

Controls the project budget by ensuring that project team member understand the hours allocation for each task and review time billed to the study against the budget to control write-off and identify out of scope activities for change orders;

Ensures that study specific documents and project deliverables (e.g., study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) are developed on time and meet study requirements;

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Education

B. Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience;

Experience

At least 5 years of clinical research experience including prior monitoring experience and at least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;

Knowledge and skills

Fluent in English (excellent oral and written);

Strong knowledge of ICH/GCP standards and applicable regulatory requirements;

Excellent mastery of Microsoft Office suite (Word, Excel, Power Point);

Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites and sponsors;

Excellent leadership, organizational, time management and multi-tasking skills;

Excellent judgement and problem-solving skills;

Travel up to 30% of the time;

Experience in a CRO and in dermatology an asset.

Our company

The work environment

At Indero , you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

Work location

Note that this opening is for a home-based position in Canada

Regular travel, which may include overnight trips and / or international travel is required as part of this role.

About Indero

Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.

Description de poste

Gestionnaire d'essais cliniques II, phase précoce et recherche translationnelle - Canada, Amérique du Nord

Le gestionnaire d'essais cliniques I, phase précoce et recherche translationnelle (CTM II, EPTR) est responsable de la gestion opérationnelle et de la supervision des sites d'investigation clinique ainsi que des résultats de la surveillance clinique des essais cliniques de phase précoce.

Cela inclut, sans s'y limiter, la formation des attachés de recherche clinique (ARC), l'identification des problèmes de qualité liés aux performances des sites et aux activités de surveillance clinique, l'établissement de plans d'action pour remédier à ces problèmes, ainsi que le respect des délais.

Le CTM II, EPTR peut également assumer des responsabilités de gestion de projet dans le cadre d'essais sélectionnés avec une participation limitée du promoteur (par exemple, observation, IIS, etc.).

Ce poste sera parfait pour vous si

Vous aimez travailler avec un CRO de taille moyenne de propriété canadienne où vous pouvez établir des relations professionnelles avec vos collègues à tous les niveaux

Vous apportez une expérience antérieure dans la gestion de la partie suivi clinique (monitoring) des projets cliniques

La dermatologie et la rhumatologie sont des domaines thérapeutiques que vous appréciez ou sur lesquels vous souhaitez en savoir plus