Job Overview:

Primary client contact for assigned clinical studies or programs, working independently with generally complex strategy, multiple vendors, sub-CROs. May have other Project Managers working in a matrix environment with program level oversight

• With a primary focus on operational delivery, develops strategies to manage risk and control and improve operational execution. Utilize staff to maximize contribution and organizational effectiveness.
• Mentor junior staff to ensure efficient and effective day-to-day operations
• Success in the role involves leveraging experience to drive solutions, developing and maintaining repeat clients and expanding client portfolios

Summary of Responsibilities:

• Leads the project team to facilitate the successful design, implementation, tracking and maintenance of all project plans, adhering to professional standards and SOPs, according to contracted timelines and budget

• Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client

• Proactively lead quality control and risk assurance activities to meet regulatory, internal and client requirements

• Fosters positive client experiences through effective communication and collaboration

• May serve as a primary contact for a strategic client relationship. Develops and manages strategic relationship level metrics. Initiates process improvement to address variance.

• Designs delivery strategy for large scale bid defense and performs other business development activities.

• Responsible for developing and maintaining client relationships and acquiring new business

• Mentors junior staff

• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Fluent in English, both written and verbal
• Comprehensive knowledge of the clinical development spectrum and ICH GCP
• Expert level organizational and time management skills
• Proven critical thinking and problem-solving skills with a proactive approach to identifying and resolving project related issues
• Effective presentation skills for staff at all levels, including internal leadership and external partners
• Actively participates in organizational initiatives

Experience (Minimum Required):

• University/college degree (life science preferred)
• Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO including at least four (4) years of full project management responsibility
• In lieu of above experience requirement, a combination of other relevant and equivalent experience may be considered

Preferred Qualifications Include:

• PMP or certified in clinical research

Work Environment:

• May travel 20% - 30% of the time to fulfill client needs, attend meetings, visit sites and company businesses and for training needs.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

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