[Hiring] Project Manager, Early Phase and Translational Research @Indero

Role Description

The Project Manager, EPTR ensures the successful initiation, planning, execution, monitoring, controlling, and closure of assigned Early Phase clinical research projects. In addition, the Project Manager, EPTR is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables of the trials. The Project Manager I, EPTR must ensure compliance with the study budget, project scope, and timelines in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory, and study-specific requirements. These tasks are done under close supervision by Senior Project Manager/Program Director and/or Director, EPTR.

This role will be perfect for you if:

• We can count on you to deliver results while using a disciplined approach to project management.
• You are looking for the next career step to prepare you to become a project manager.
• You are knowledgeable about clinical research projects and looking to continue learning.
• Working in an organization that is driven by science and innovation and completing meaningful work is important to you.

More specifically, the Project Manager, EPTR:

• May serve as primary contact for the Sponsor, sites, CRAs, vendors, and internal team throughout the study. Depending on the scope of the study, may lead the project.
• Coordinates tasks and deadlines between the different departments involved in the project.
• Oversees project coordinators, SSU team members, RDA, and RAC resources to ensure correct prioritization of site activation activities amongst team members.
• Interacts with vendor management to ensure vendor supplies and services are coordinated with site activation timelines.
• Escalates to project manager when site activation timelines are at risk or cannot be maintained.
• Assists with managing the needs and expectations of the Sponsor and other internal and external project stakeholders.
• Assists with ensuring all team members are adequately trained on the project.
• May plan the activities and resources (e.g., internal and external resources, equipment, etc.) required for the project.
• Manages the quality of assigned work and deliverables.
• Assists with providing project status updates to external and internal stakeholders.
• Ensures assigned tasks are completed in compliance with the study budget, project scope, and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements.
• Reconciles study trackers.
• Assists with analyzing discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed.
• Assists with enforcing effective change control and risk management throughout the project.
• Reviews and may assist in the drafting of project operational plans, processes, and manuals as applicable (e.g., project management plan, monitoring plan, etc.).
• Assists with ensuring that study-specific documents and project deliverables (e.g., protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) meet applicable country requirements.
• Oversees activities related to site selection (feasibility questionnaires, site selection, planning of site qualification visits).
• Monitors patient recruitment, subject status, and follows up with sites on recruitment strategy plan.
• Participates in the planning and conduct of Investigator’s Meeting.
• In collaboration with the Regulatory Affairs group, may oversee activities related to central ethics and regulatory submissions.
• Ensures collection of required essential documents from the sites prior to study initiation and maintains the currency of site-level documentation throughout the study.
• May assist the project manager with quality reviews and/or audits of the Trial Master File (TMF) to ensure inspection readiness.
• May support clinical monitoring activities, such as CRA training, development of annotated site visit reports and monitoring tools, perform visit report review, site letters, and identification of quality issues and trends related to site performance and clinical monitoring activities.
• May serve as a point of contact for CRAs and Lead CRAs for assigned projects.
• May track site qualification, initiation, routine and close-out visits, project-specific training, monitoring visit reports and follow-up letters, compliance with monitoring plan, escalation of site-related issues.
• Maintains the project-specific training matrix and confirms project team members are fully trained per the study matrix prior to team members performing study tasks.
• Supports the sites and ensures that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• In collaboration with the Data Management group, may ensure that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines until database lock.
• Supports development of study-specific trackers and sites and Sponsors dashboards in Smartsheet.
• May provide technical, therapeutic, and project management expertise in training and process improvement efforts for the department.
• The Project Manager I, EPTR, may also assume the following responsibilities: With adequately documented training, perform limited clinical monitoring activities such as initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines, and applicable regulations.

Qualifications

• B.Sc. in a related field of study to clinical research.

Requirements

• Minimum 3 years of relevant industry experience in the pharmaceutical, biotechnology, or CRO industry.
• At least 2 years experience coordinating activities related to clinical trial management.
• At least 1 year experience coordinating early phase studies.
• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations.
• Excellent knowledge of Microsoft Office suite.
• Excellent oral and written skills in English, French is an asset.
• Excellent communication skills.
• Ability to work in a team environment and establish good relationships with colleagues and sponsors.
• Strong sense of creativity and process improvement.
• Excellent judgement and good problem-solving abilities.
• Good problem-solving abilities.
• Strong ability to carry out different projects and work under pressure while meeting timelines.
• Detail-oriented and excellent documentation skills.
• Quick learner, good adaptability, and versatile.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Benefits

• Flexible work schedule.
• Permanently full-time position.
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities).
• Ongoing learning and development.

Company Description

Innovaderm 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, Innovaderm continues to grow and expand in North America and Europe.