Project Manager II, dermatology and rheumatology CRO,USA

Indero•Boston, MA

12d•Remote

About The Position

The Project Manager II is responsible for the successful initiation, planning, execution, monitoring, control, and closure of assigned clinical trials. The role oversees and coordinates study resources to ensure compliance with budgets, scope, timelines, SOPs, good clinical practices, regulatory requirements, and study-specific requirements. The Project Manager II serves as the primary communication contact for relevant stakeholders and contributes to feasibility, study design, and budget development, while reporting on resources, budget, and timelines. The role leads sponsor interactions, project planning and start-up, quality and risk management, budget and timeline control, and project team leadership. It coordinates internal functional teams and external vendors to deliver multisite clinical trials, including global Phase III projects. The position is home-based and offers a flexible work schedule, ongoing learning and development, and advancement opportunities.

Requirements

B.Sc. in a field related to clinical research.
At least 5 years of industry experience.
At least 3 years of experience in Phase I–III clinical trial project management.
Experience managing dermatology and/or rheumatology trials.
Experience leading concurrent multicenter clinical trials with budgets exceeding USD $3 million.
Excellent knowledge of GCP and ICH standards, and FDA and Canadian regulations.
Excellent knowledge of the Microsoft Office suite.
Excellent oral and written English skills.
Excellent communication skills.
Ability to work in a team environment and establish good relationships with colleagues and sponsors.
Good problem-solving and organizational skills.
Ability to manage different projects and work under pressure while meeting timelines.
Must be legally able to work in the United States.

Nice To Haves

Experience managing dermatology trials.
French language skills.

Responsibilities

Serve as the primary contact for the Sponsor, provide timely trial progress updates, and lead client calls.
Oversee and participate in preparation of study deliverables, including study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.
Participate in planning and conducting Investigator’s Meetings.
Ensure study sites have the materials required to conduct the study, such as investigational product, study supplies, special equipment, and safety lab kits.
Lead study start-up activities, including trial kick-off, TMF setup, site selection and activation, vendor setup timelines, and site contracting and budgeting.
Collaborate with Regulatory Affairs to support timely submissions and complete essential documents before site initiation and throughout the study.
Partner with Data Management to align CRFs with protocol and sponsor requirements and meet data review, query resolution, and database lock timelines.
Keep assigned studies audit-ready, monitor the quality of study and vendor/SubCRO deliverables, address issues, and manage project risks and controls.
Analyze discrepancies between planned and actual results and review and approve responses to quality assurance audits.
Control project budgets, including internal hours; identify out-of-scope activities requiring change orders.
Proactively manage trial timelines, budgets, resources, and vendors; coordinate functional department tasks and deliverables.
Communicate with study team members, functional departments, and senior management.
Manage and report recruitment status and identify initiatives needed to meet recruitment timelines.
Lead the core project team, which may include Associate Project Managers, Project Coordinators, and Project Assistants.
Ensure project team members receive adequate training and maintain the project-specific training matrix and current training records.
Coordinate with vendors and internal Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams to ensure timely, standards-compliant deliverables.