Job description

Title: Director of Project Management

Position: Part Time or Full Time / W-2 or Contract

Location: Remote

Summary:

Responsible for overall cross-functional leadership of assigned projects and project teams to ensure delivery within specified client defined budgets and timelines and in accordance with applicable regulatory guidelines/requirements.

Independently serves as Project Manager, Program Manager, or Global Project Lead on complex studies, applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, an investigational product, and client. Act as a role model and coach for the internal project team and expected to build positive rapport with the internal and external project teams.

Will have line management responsibilities for Project Management personnel and the strategic development and continuous improvement of project management processes.

Job Duties:

• Lead/Perform independently, with minimal guidance and oversight
• Maintain a detailed understanding of the assigned portfolio of project(s) scope of work and associated contractual agreements
• Mentor, train more junior staff, in the nuances of managing a development project: management of team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, coaching on R&D/company processes, relating to development team management, strategic document preparation, project management skills and team management
• Act as the primary point of contact for clients project(s)
• Regularly communicate with senior management on matters concerning resource allocation, project milestones, regulatory issues, risks, issues and other relevant issues
• Organize and host regularly scheduled and ad hoc meetings with the project sponsor and/or third-party vendors to monitor study progress, issue agenda and meeting minutes
• Identify and manage resource needs throughout the execution of projects
• Lead cross-functional teams and third parties/vendors to ensure effective teamwork and maintain a detailed understanding of each functional service area on the project
• Manage project deliverables including timeline, quality, scope, and financials.
• Develop a project-specific plan(s) as required by the client, in addition to the project specific Project Management Plan
• Risk Management: identify, monitor and report on the risk factors influencing clinical, CMC non-clinical, and regulatory development plans. Support team members to identify risk mitigation plans and ensure cross-functional risk management and reporting
• Oversee and manage operational quality and risk assessment, mitigation, and management of all projects
• Review and provide comments on clinical study-related documents including Protocol, Informed Consent Form, and Clinical Study Report. May be asked to author documents
• Ensure inspection-ready Trial Master File (TMF) for the duration of the project(s); perform maintenance tasks such as filing; lead periodic quality reviews; prepare for audits and archiving
• Anticipate client needs and proactively resolve issues as necessary
• Develop in-depth analysis and projections of project timelines and financials
• Oversee and coordinate Project Manager(s) working on assigned projects
• May assist with the identification of Project Management Department initiatives and independently work on assigned initiatives
• Have have line management responsibilities (including interviewing and selection, terminations, professional development, and performance appraisals of Project Managers)
• Work with Business Development to identify new project opportunities
• Provide assistance in the development of study contracts, budgets, change orders and proposals

Knowledge & Skills:

• Detail oriented
• Collaborative
• Strong leadership presence
• Extensive experience in the clinical drug development process
• A deep understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management
• Strong scientific background
• Excellent communication skills
• A passion for coordinating strategies, resources, timelines and continuous improvement initiatives across multiple functions and activities
• Excellent verbal and written communication skills
• Ability to work independently with minimal supervision
• Punctual
• Flexible
• Experience in an office environment is required

Education and Experience:

• Requires a Bachelor’s degree or higher, preferably, in a scientific discipline or equivalent
• A minimum of 10 years of project management experience in clinical research in the pharmaceutical and/or contract research organization industry, and at least two years of project management/project leader experience with multi-site patient studies. Equivalent experience may be considered
• Strong working knowledge of ICH guidelines and GCPs required
• Excellent verbal and written communication and time management skills are essential
• Proficient in use of Microsoft Word, Excel and Project
• Ability to interact with clients, all levels of management, vendors, and study site personnel.

Job Types: Full-time, Part-time, Permanent

Pay: From $50.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Compensation package:

• Performance bonus

Experience level:

• 10 years

Schedule:

• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Clinical Project management: 10 years (Required)

Work Location: Hybrid remote in Newtown, PA 18940

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