Project Manager, Clinical Research


Note: in light of the current context which affects recruitment for many organizations globally, recruitment for this positionmight be delayed.

If you are interested in this opportunity, we still welcome your application.

Throughout this, our recruitment team remains dedicated to a quality candidate experience which may include interviews conducted via phone and / or video conferencing. Thank you for your understanding.

 

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The project manager has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The project manager must ensure 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.

The project manager has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The project manager must ensure 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.

 

RESPONSIBILITIES

 

The Clinical Project Manager:

 

  • Oversight of study activities in Europe and Asia Pac region.
  • Conduct as needed quality oversight visits of Innovaderm CRAs and SubCROs for studies conducted in Europe.
  • Provide input on regulatory and ethics processes in countries in Europe.
  • Serves as primary contact for the Sponsor, vendors and internal team throughout the study.
  • Manages the needs and expectations of the Sponsor and other internal and external project stakeholders.
  • Ensures all team members are adequately trained on the project.
  • Plans the activities and resources (e.g. internal and external resources, equipment, etc.) required for the project.
  • Manages the quality of assigned personnel work.
  • Provides project status updates to external and internal stakeholders ensuring 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.
  • Develops/reviews clinical project operational plans and manuals as applicable (e.g., project management plan, monitoring plan, etc.).
  • Ensures 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 requirements.
  • Oversees activities related to sites selection (feasibility questionnaires, sites selection, planning of site qualification visits) and patient recruitment (monitors patient recruitment status, follows-up on recruitment strategy plan).
  • Participates in the planning and conduct of Investigator’s Meeting.
  • In collaboration with the Regulatory Affairs group, oversees activities related to central ethics and regulatory submissions. Ensures collection of required essential documents from the sites prior to study initiation. Ensures that the Trial Master File (TMF) is complete and accurate.
  • Oversees clinical monitoring activities for site qualification, initiation, routine and close-out visits (i.e. project-specific training of CRAs, reviewing monitoring visit reports and follow-up letters, ensuring compliance with monitoring plan, escalation of site-related issues).
  • In collaboration with the data management group, ensures 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. 
  • May act as mentor for new staff or for more junior staff.
  • Participates in business development activities in Europe.
  • 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.

 

Work location

 

  • Note : this posting is for a remote (home-based) position located in Europe.
  • The candidate must be authorized to work legally in the country where they will be based.

PROFILE

  • B.Sc. in a related field of study to clinical research;
  • 5 to 7 years total experience as project manager for early and late phase studies in dermatology or rare disease, including 3 to 5 years of experience as project manager for multi-centered Phase II & III trials in multiple countries in Europe and Asia Pac regions;
  • Experience building client relationships and participating in bid defenses;
  • Excellent knowledge of GCP, ICH standards, EMEA regulations and MHRA regulations;
  • Excellent knowledge of Microsoft Office suite;
  • Fluent in English with excellent oral and written skills;
  • Ability to work in a team environment and establish good relationships with colleagues and sponsors;
  • Good problem-solving abilities;
  • Strong ability to carry out different projects and work under pressure while meeting timelines.

 

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.

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