Clinical Project Manager
Valide du: 08/01/2018 au 10/25/2018
The Clinical 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.
Duties and Responsibilities:
- 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.
- 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.
Skills and Requirements:
- Sc. in a related field of study to clinical research;
- At least 3 years of experience in project management in a clinical research environment;
- Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations;
- Excellent knowledge of Microsoft Office suite;
- Bilingual (English and French) 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.
We thank you for your application and please note that only those selected for an interview will be contacted.
Innovaderm only accepts applicants with a work permit for Canada.