Project Manager II, Oncology with CAR-T
Therapeutic Area Experience Required: Oncology, CAR-T
Home-Based Anywhere in the United States or Canada & Full-Time
Typically, under the direction of a Senior Project Manager/Project Director, the Project Manager oversees and manages domestic, regional, and/or international projects. Responsibilities include managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met. The Project Manager is expected to have working knowledge of drug development and clinical trial execution. The Project Manager also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data.
Essential Job Duties:
- Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence, and thereby increase potential for repeat business.
- For areas of project responsibility, lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director.
- Serve as escalation point for project issues, within area of project responsibility, to internal and external stakeholders, as appropriate.
- Proactively identify and resolve conflicts as needed.
- Monitor project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
- Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
- Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements.
- Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member's respective supervisors.
- Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
- Define and manage project resource needs and establish succession plans for key resources.
- In collaboration with relevant departments, prepare and deliver presentations for new business as required.
- Perform other duties as assigned by management.
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Masters or other advanced degree.
- PMP certification.
Minimum Qualifications Required:
- 1 + years of current experience working as a Project Manager at a CRO managing full-service global Oncology trials/studies including CAR-T.
- The responsibility of the financial management of the studies.
- Minimum of five (5) years relevant clinical research experience in a pharmaceutical company/CRO.
- In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including one (1) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered.
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Working knowledge of project management processes.
- Experience managing projects in a virtual environment.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
- Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
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