Allucent is hiring a
Sr. Clinical Project Manager, Remote - United States
Allucent
π΅ $70k-$120k
πUnited States
Summary
The job is for a Senior Project Manager at Allucentβ’ to manage clinical trials from start to finish, with a focus on small-medium biopharmaceutical companies. The role requires experience in Government and Vaccines or COVID-19 clinical trials, preferably familiarity with decentralized clinical trials.
Requirements
- Minimum Bachelorβs degree in life science, healthcare and/or business degree
- Minimum 5 years of relevant work experience
- Minimum 5 years of experience in drug development and/or clinical research, with at least 2-3 years of clinical trial project management experience
- Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
- Demonstrates strong financial acumen, administrative excellence and analytical skills
Responsibilities
- Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
- Creates and executes project management plans required for project delivery and in accordance with established processes
- Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines
- Establishes clear communication lines and escalation pathways, communicates with project stakeholders
- Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report
- Establishes requirements for and ensures project specific training plan for team activities
- Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
- Provides support for vendor identification, qualification and selection and manage vendors
- Manages vendors and vendor relationships as required for project delivery
- Ensures effective and efficient resource utilization across projects and programs
- Produces, maintains and circulates project progress and status reports
- Manages the study budget, including monthly invoicing
- Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle
- Proactively recognizes and addresses any changes in scope
- Negotiates and influences internal and external team members in a professional manner and with successful outcomes
- Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
- Conducts review of initiation, monitoring and close-out visit reports
- May perform co-monitoring visits
- Ensures the Trial Master File is kept up to date and inspection ready
- Serves as the primary point of communication between the sponsor and project team
Preferred Qualifications
Preference for candidates with CRA experience
Benefits
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
This job is filled or no longer available
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