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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