Description:

A Day’s Work in This Position:

•Works under minimal direction to develop comprehensive program plans, which identify objectives, strategy, risks/risk mitigation, budget, effort estimates, and schedules.

•Establishes and maintains processes and procedures for managing scope during the project lifecycle, setting quality and performance standards and assessing risks.

•Produces accurate project timeline and reports, when necessary, revises the scope, schedule, or budget to ensured deliverables can be met.

•Leads core teams towards program objectives.

•Communicates at all levels of the company in order to represent objectives, risks, and needs for program delivery.

•Organizes communication with study teams, and integrates administrative activities in support of basic, translational, and clinical research projects.

•Manages contractual project deliverables, agreed timelines, quality/scope, and cost by actively communicating with CROs and other stakeholders.

•Works with the finance team to develop and maintain project documentation (project scope, schedule, budgets, communication plans, & etc.) and monitor financial progress throughout the study.

•Supports finance team for audit processes related to program deliverables.

•Works closely with cross-functional team as well as R&D team in Japanese subsidiary, as needed, to ensure alignment and prioritization around schedules, portfolio management, contractual obligations and budgets. Guides and trains members of the group to achieve goals.

•Leads, documents, and communicates constructive lessons-learned in after-action analysis of completed programs. Reports and escalates project program issues to management as needed.

Additional Skills & Qualifications:

Required Skills and Abilities:

• Outstanding communication skills, both verbal and written

• Proficient with Microsoft Office suite

• Ability to work independently and prioritize duties.

• Mastery of program management system(s)

• Understanding of Electronic Data Capture (EDC)

• Ability to respond flexibly and positively under conditions of uncertainty or change

• Ability to travel

Education and Experience:

• Bachelor’s degree or higher in Science, Life Sciences, Medicine, Education, Nursing, Pharmacy, Health, Life Science, Management

• A minimum of 5 years’ program management experience

• A minimum of 5 years’ financial acumen and budget management experience

• A minimum of 3 years’ experience with CROs, other clinical vendors, and outsourced operations

• Experience with regulatory and clinical teams preferred

• 5 years of experience in clinical and drug development in the biotech/pharmaceutical industry

• Experience with preclinical and clinical projects and cross-functional project teams

• Experience with regulatory submissions

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.