Senior Project Manager - Dermatology/Rheumatology (USA)

Indero•Portland, OR

About The Position

Projects Managers with experience in Dermatology and/or Rheumatology are crucial to the success of Clinical Trials managed by Indero. 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 wishes to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects and is looking to position themselves in an environment where you can grow your career alongside of a growing company.

Requirements

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

Nice To Haves

PMP or PRINCE2 certification is an asset
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
Bilingualism (English and local language) is an asset

Responsibilities

Serve as primary contact for the Sponsor
Provide efficient and timely updates on trial progress
Lead client calls effectively
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 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.).
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.
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.
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.