Senior Clinical Project Manager
An opportunity has opened for a Senior Clinical Project Manager/ Leader to join a small, global CRO in a fully home-based role on the east coast of the US. This is a unique role focusing both in operations and strategy which will give you the chance to step up very quickly within the company.
This position is open due to recent growth within the company. Their target clients are the smaller, niche Biotech companies that target the most aggressive forms of cancer so having a strong oncology background is essential for this position.
- Takes full leadership on all project deliverables on assigned projects, ensures that project deliveries are on time, within budget and with quality
- Proactively identifies areas for process improvement and provides suggestions on process changes
- Builds and manages the study budget, implement actions to mitigate areas of risk, drive delivery across the full project, collaborate with internal stakeholders to track study progress and create study tools
- Analyzes Study Protocol in order to define scope of services for internal and external Providers project success and identify risks from the beginning of the project
- Coordinates and manages project start-up, project maintenance, and project close-out activities
- Effectively drives client and internal team communication, leads teleconferences and meetings with Sponsor, Services Providers, proactively communicates project status, issues & risks to stakeholders and management
- Provides leadership to the study team members as well as relevant vendors
- Sets up all relevant study plans and keeps them updated throughout the study execution
- Takes ownership of project issues and proactively drives to resolution
- Follows applicable SOPs and regulations, maintains study status tracking tools up to date and drives team member's compliance
- Prepares reports on the assigned activities according to the requirements and timelines
- Reviews clinical trip reports
- Coordinates work of Services Providers, communicating to the Sponsor all decisions and deviations related to service providers. Closely works with Vendor Manager on associated contracting
- Closely collaborates with Project Finance Management in the project finance oversight and addresses issues/incompliances immediately until resolution
- As applicable, supports preparation of Bid Defense Meetings
- Leads activities in Investigators Meeting preparation and conducts it; agrees on meeting agenda and the list of presentations, participates in the meeting as a host and presenter
- Delegates skillfully and seamlessly operational study tasks to other study team depending on their ability to perform the task
- Provides mentoring to APL/PLs and more junior Project Managers
- Performs Site Engagement visit to assigned country in line with Department strategy
- Participates in sponsor audits and Regulatory Authority inspections
- Assures compliance with assigned trainings prior to executing relevant tasks and proactively identifies and communicates development needs/mentoring opportunities to ensure continuous learning in the path of project management
- University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- Significant experience in project management of clinical trials (minimum 1 year of Project Management experience)
- Previous or current CRO/sponsor experience or Medical Device Manufacturer experience
- Broad knowledge of medical terminology, clinical patient management and clinical research methodology
- Advanced team leadership skills
- Advanced decision-making skills
- Demonstrates sound judgment in decision making process and has strong understanding of scope of contracts, including milestones and recognition of changes
- Measurable knowledge of Good Clinical Practice (GCP) requirements and local regulations for conducting clinical trials
- Solid analytical, negotiation and communication skills
- Advanced computer competency
- Good presentation skills
- Fluent in local office language and strong in English, both written and verbal
- Available for travel up to 20% of the time, including overnight stays as necessary, consistent with project needs and office location. Ability to travel locally and internationally.
- Ability to drive; has a valid driver's license
A highly attractive financial package and flexible working is on offer, along with the chance to develop quickly with the company.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.