Senior Project Manager

Fortrea

$90K — $120K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Fluent in English, both written and verbal
  • Comprehensive knowledge of the clinical development process and ICH GCP
  • Expert organizational and time management skills
  • Proven critical thinking and proactive problem-solving skills
  • Effective presentation skills for diverse audiences
  • Participation in organizational initiatives preferred

Responsibilities

  • Lead project team for successful study design and implementation
  • Accountable for Trial Master Files (TMF) and audit readiness
  • Proactively perform quality control and risk assurance activities
  • Facilitate positive client experiences through effective communication
  • Manage strategic client relationships and continuous improvement initiatives
  • Design strategies for large-scale bids and business development
  • Mentor junior staff and support daily operations

Benefits

  • Potential travel opportunities (20%-30%) for client engagement and training
  • Opportunity to mentor and develop junior staff
  • Work within a collaborative and dynamic team environment
  • Engagement in meaningful clinical research projects
  • Possibility for professional growth through client relationship management
Full Job Description
Our Phase I team is currently seeking a Sr. Clinical Project Manager with 4+ years of project management experience residing in Canada. Ideal candidates would have phase Ib experience.

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
  • 4+ years of full project management responsibility within a CRO or pharma company
  • 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
  • Phase Ib experience


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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