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Project Manager, Early phase

3 months ago

Canada, CA Innovaderm Research Full time

Projects Managers are crucial to the success of Clinical Trials managed by Innovaderm. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.

Great project managers go further than creating project plans and following up on tasks. They show leadership to help project teams focus on objectives and deliver results.

This role will be perfect for you if:

  • You are a hands-on project manager who enjoys working on multi-site early phase projects including Phase I, Phase IIA / proof of concept as well as Investigator-Initiated studies.
  • You enjoy helping look for ways to improve and simplify processes to better respond to the needs of Early phase projects in a regulated environment.
  • You wish to work for a mid-sized CRO that works on significant multisite trials
  • You are looking to position yourself in an environment where you can grow your career alongside of a growing company.

IMPACT AND RESPONSIBILITIES

Client interactions

  • Serve as primary contact for the Sponsor
  • Provide efficient and timely updates on trial progress

Project planning and execution

  • Oversee and actively participates in the preparation of project deliverables such as; study plans (including the monitoring plan), protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
  • Participate in the planning and conduct of the Investigator’s Meeting.
  • Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
  • Develop the annotated site visit reports and monitoring tools such as source data verification worksheets.

Quality and risk management

  • Oversee clinical monitoring activities, including
  • Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
  • Manage risk and control measures to assure project quality.
  • Analyze discrepancies between planned and actual results.
  • Review and approve responses to quality assurance audits.

Project budget and timelines

  • Control the project budget, with particular attention to internal hours allocated to all activities.
  • Identify out of scope activities for change orders.
  • Proactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
  • Communicate effectively with study team members, functional departments, and senior management.
  • Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.

Project team leadership

  • Ensure all team members have adequate training on the project.
  • Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
  • Prepares and conducts project-specific training for CRAs

IDEAL PROFILE

Education

  • B.Sc. in a related field of study to clinical research
  • M.Sc. or Ph.D. an asset

Experience

  • At least 5-7 years of industry experience, including a minimum of 3 years in Phase I-II clinical trial project management
  • Experience leading concurrent multi-centered clinical trials involving multiple countries / regions is an asset
  • Experience in one or more of the following considered an asset: study start up, regulatory submission, clinical monitoring (CRA), or vendor management
  • Experience managing dermatology trials an asset

Knowledge and skills

  • Excellent knowledge of GCP and ICH standards, FDA and local country regulations
  • Excellent knowledge of Microsoft Office suite
  • Fluency in English with excellent oral and written skills, required
  • Bilingualism (English and French) is an asset
  • Ability to work in a team environment and establish good relationships with colleagues and sponsors
  • Strong ability to carry out different projects and work under pressure while meeting timelines
  • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
  • Good problem-solving, critical- and creative-thinking abilities
  • Strong scientific acumen
  • Strong cross-functional knowledge in clinical research

OUR COMPANY

The work environment

At Innovaderm, 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.

In this position, you will be eligible for the following perks:

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

About Innovaderm

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.

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

Innovaderm only accepts applicants who can legally work in Canada.

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