Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.
We are currently recruiting for a Project Manager II/ Sr. Project Manager to join our team in the US with the option to work remotely. The Project Manager II (PMII)/ Sr. Project Manager (Sr. PM) is responsible for the overall coordination and management of clinical trials from start up through to final delivery. This position directs the technical and operational aspects of clinical projects – all with the sense of urgency expected of Allucent customers. Candidate must have oncology experience; preference for early phase oncology, along with immune-oncology and/or cell therapy.
Location: US (remote)
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
Client management:
- Serves as the primary point of communication between the sponsor and project team
Leadership:
- Leads by example and encourages team members to develop strong solutions for clinical trial delivery
- Responsible for oversight of project team delivery and communication with functional managers, including performance feedback
Requirements
Qualifications:
- Minimum Bachelor’s degree in life science, healthcare and/or business degree
- Minimum 5 years of relevant work experience
- Minimum 5-7 years of experience in drug development and/or clinical research, with at least 2-3 years of clinical trial project management experience
- Preference for candidates with CRA 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
- Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).
Skills:
- Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language
- Representative, outgoing and client focused
- Ability to work effectively in a fast-paced challenging environment with a growing company
- Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required
- Strong presentation skills
- Fosters learning and the advancement and development of others
- Dependable and able to take action to quickly to address urgent needs
- Proactive and solution oriented
- Willingly takes ownership and drives positive, collaborative results with the project team
- Exercises good judgement with defined procedures and policies to determine appropriate action
How to Apply: https://apply.workable.com/allucent/j/A907059558/apply/