2024-05-15
AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
San Diego
California
92189
United States
Senior Projects Managers with experience in Rheumatology 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.
We are looking for someone who:
Has at least 7 years of Global clinical project management experience (including but not limited to European regions), including management of all projects phases from start-up to closure, management of all functional services, vendor management.
Has previous experience managing Rheumatology indications studies.
Wishes to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects.
Is looking to position themselves 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
Lead client calls effectively
Project planning
Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
Participate in the planning and conduct of the Investigators 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.).
Quality and risk management
Ensure assigned studies are audit ready at all times.
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
Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
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.
Requirements:
IDEAL PROFILE
Education
B.Sc. in a related field of study to clinical research;
PMP or PRINCE2 certification is an asset
Experience
At least 10 years industry experience including a minimum of 3 years in a CRO;
At least 7 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe)
Experience leading multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
Experience in one or more of the following considered an asset: study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management;
Therapeutic experience managing dermatology, onco-dermatology, rheumatoid arthritis or oncology trials an asset
Knowledge And Skills
Excellent knowledge of GCP and ICH standards, local country regulations;
Excellent knowledge of Microsoft Office suite;
Fluency in English with excellent oral and written skills, required
Bilingualism (English and local language) is an asset
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;
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:
Flexible work schedule
Permanent full-time position
Medical benefits
Vacation and personal days
100% remote role
Ongoing learning and development
Recruitment process: what to expect
As part of the recruitment process for this position you will meet various team members at Innovaderm
The first interview will be conducted by video conference (30 - 45 minutes) and the second via video conference (1 hour)
The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.
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 USA.
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