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

Indero•Montreal, QC

22h•Remote

About The Position

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

Requirements

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

Nice To Haves

Experience in a CRO and in dermatology an asset.

Responsibilities

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)).
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;