Project Manager, Innovation & Change Management Clinical Operations

The primary purpose of the Project Manager (PM) is to provide project management enablement focused on bridging people, process, data and technology for the implementation, optimization and maintenance of our client's clinical trial delivery operating model.

The project manager will contribute to the mission by managing time, effort, deliverables, communication, and value associated with high quality delivery of one or multiple projects in support of the clinical trial delivery operating model. This will include but is not limited to cross functional process optimization, training initiatives, change management and/or technology implementation efforts.

The project manager will:

• Lead project and change management implementation efforts, including establishing well defined, transparent project plans, creating content, reference documentation and tools to ensure success of on time delivery
• Proactively identify, track, manage and escalate action items, risks, issues, decisions, and dependencies.
• Manage the key relationships between all stakeholders to deliver on project and program mission and objectives
• Drive continuous delivery of value using agile life cycle management from communication, development, optimizations, and performing quality control on projects throughout the journey.
• Proactively monitor and maintain project-related end-to-end customer/business experiences and influence relevant stakeholders to support and deliver successful project milestones while making effective decisions when presented with multiple options.
• Coordinate project team meetings and serve as a point of contact for the project teams when cross-functional activities are identified to ensure team actions remain in synergy.
• Partner with peers within program to drive continuous improvement and optimization of processes, user experiences, and applications aligned with business stakeholders and PTDS I&CM shared service model.
• Highly cross-functional role with broad scope of responsibilities
• High visibility and critical impact on the future of the business

ACCOUNTABILITIES:

The Project Manager is expected to support Process, Training and Digital Solutions with various activities and projects. Responsibilities include:

• Lead development and maintenance of project plans, key milestones and change management activities,
• Assist with maintaining centralized action/risk/issue/decision/dependency log and mitigation tracking for project(s),
• Schedule meetings with project team members and partners to identify and address project needs and escalations,
• Build and maintain project team materials including summaries of key decisions/outcomes and action items
• Facilitates communication of project outcomes as appropriate through email, internal communication sites, other department meetings, etc.
• Assists in the monitoring and management of the project(s) progress, schedules and resources
• Closely monitor project plans, gather relevant data to continuously gain new insight and adjust roadmaps, offering to optimize performance and effectiveness.
• Proactively identify potential issues or obstacles and plans contingencies. Follow issues through to resolution ensuring that all key stakeholders are informed of outcomes and implications.
• Support project teams and business in establishing measurable value targets for the project and track outcomes
• Contribute to maximizing clinical trial delivery process efficiency and regulatory compliance by identifying opportunities for innovation as it relates to process, adult learning approaches and effective strategies for organization adoption
• Manage communication with stakeholder and customers in relation to GxP and non GxP process, training and digital solution activities
• Support system development and maintenance process for supported functional areas with relevant SMEs, stakeholders, and Quality; ensure consistency in document portfolios
• Champion change and provide direct change management support for project and initiatives associated with functional area initiatives
• Ensures consistency and alignment across interdependent processes to provide holistic oversight
• Ensure all aspects projects are planned and executed in line with goals, timeline, and budget
• Contribute to the development and preparation of key communications to strengthen and support change management efforts
• Support implementation of global initiatives

EDUCATION/COMPENTENCIES/SKILLS:

• BS, MS or equivalent
• Minimum of 6 years program/project management experience leading complex in a multidisciplinary, global environment, PMP (Project Management Professional) certification is a plus
• Solid knowledge of clinical trial management and/or GCP compliance processes is preferred
• Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required
• Comprehensive knowledge of regulatory requirements governing clinical trials and industry best practices is preferred
• Must be able to efficiently utilize computer software programs such as Microsoft Office project management and presentations
• Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving
• Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
• Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and project teams to turn vision into reality.
• Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects
• Extensive experience in design or in implementing solutions and preferable experience in quality improvement.
• Excellent oral and written communication skills, business acumen, and enterprise knowledge.
• Understand design thinking and can explain and convince stakeholders.
• Work with virtual/agile teams in different locations, aligning and adapting different work, culture, and communication styles.
• Effectively communicate complex problems and proposed solutions across various levels of the organization
• Function well under pressure in a changing environment

EXPERIENCE:

Solid project management and problem-solving skills with the ability execute on plans with limited direction and support

Proven conceptual thinking and strategic problem-solving ability

Ability to prioritize and lead various team members at various levels to achieve goals

Strong communication skills

Strong strategic and analytical thinking

Serve as a role model, demonstrating respect and inclusion, creating a culture that fosters innovation

Experience with the pharmaceutical industry, including research and development and especially clinical trials conduct is a plus.

Solid knowledge and experiences with GCP regulatory inspections is a plus

Proven ability to adapt to change and manage cultural change in an evolving environment.

Work in a global ecosystem (internal and external) with a high degree of complexity including geographically distributed team members and experts with different cultural backgrounds and deep level expertise

Understand a broad range of projects; distinguish priorities and explain requirements across all functions of the company

Ability to build strong relationships and collaborate with other interfacing functions, including senior leadership

Recognize opportunities for improved goals and approaches

Identify and manage interdependencies across portfolio of work

Ability to guide teams engaged to enable delivery on the clinical trial delivery operating model. It will re-quire the need to make tactical decision when needed to our operational environments.

Independently manage day to day operational issues while knowing when to escalate more critical problems or decisions in the environment

Effectively negotiate and resolve conflicts in a constructive manner

Ability to understand highly complex problems and be able to apply effective and innovative solutions to them.

Ability to have an agile time-based delivery team operate within set project delivery timelines.

LOCATION

Home Based

START & TERM

ASAP, Multi-Year Ongoing Role

RATE/SALARY/BONUS/BENEFITS

Competitive