Precision for Medicine
SeniorProjectManager-Oncology
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Project Manager - Oncology at Precision for Medicine. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, project management, clinical research, pharmaceutical research, device research. plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Serve as primary point-of-”
Industry & Context.
risk management; proactive risk management and mitigation; critical thinking; analytical skills
Ability to travel domestically and internationally including overnight stays, travel to Bid Defense meetings as required
What They're Looking For.
Must Have
Minimum of 7 years of clinical research experience or proven competencies for this position, a minimum of 4 years of direct project management experience, Experience in managing complex and global trials, Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS, Proven communication and interpersonal skills to effectively interface with others in a team setting, Proven organizational skills, attention to detail, and a customer service demeanor, Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items, Direct work experience in a global, cross-functional project management environment, Good understanding of cross-functional management, Good understanding of project planning, risk management and change management with an awareness of appropriate escalation, Proven experience in strategic planning, risk management and change management, High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective, Ability to lead and inspire excellence within a study team, Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency, Results oriented, accountable, motivated and flexible, Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills, Proven presentation, verbal and written communications skills, Good understanding of project management software, In depth proven experience in pharmaceutical and/or device research required
Nice to Have
Advanced degree preferred, experience with oncology & cell and/or gene therapy
What You'll Do.
and delivers activities for designated clinical study projects to ensure that project objectives of quality
and time are accomplished
Serve as primary point-of-contact and primary escalation point to the client
Coordinate and oversees all functional services including external vendors to the established timeline and budget
Manage the study budget
ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate
Independently drive the CO to completion and execution with support as needed
Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate
Manage the financial health of assigned studies
including oversight of the project profitability
billable project hours
and compliance with on time
accurate billing and forecasting to support business objectives
Develop robust and comprehensive project plans
including timelines and proactive risk management and mitigation
to guide all parameters of trial execution with consistency and quality
Ensure Quality management for assigned projects
including eTMF Inspection readiness
implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings
Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
Establish tracking metrics to monitor trial and team progress towards project goals
Prepare project status updates and report on progress to clients and senior management
including reporting on key performance indicators
offering solutions and opportunities as they arise
Leads both internal and client meetings and set expectations for the project team
Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
Ability to conduct formal presentations to a wide variety of audiences including colleagues
and clients including Bid Defenses with proficiency
Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
Support business development and marketing activities as appropriate
including travel to Bid Defense meetings as required
Perform other duties as assigned by management
Remain compliant with organizational training
time-reporting and any other administrative duties as required
Provides on-going feedback
for functional team members including annual performance reviews
How You'll Work.
Team & Collaboration
Coordinate and oversees all functional services including external vendors; Maintain integrated collaboration with clinical operations in the delivery; Maintain integrated collaboration with all functional operations in the delivery of the program; Leads both internal and client meetings and set expectations for the project team; Communicate effectively with client and Precision management; Ensure study specific training is implemented in collaboration with functional areas; Provides on-going feedback, for functional team members
Communication Scope
Proven communication and interpersonal skills; Proven presentation, verbal and written communications skills; Communicate effectively with client and Precision management; Ability to conduct formal presentations to a wide variety of audiences
Process & Methodology
project management, planning, directing, coordinating, delivering activities for designated clinical study projects, managing study budget, developing project plans, risk management, quality management, tracking metrics, preparing project status updates, reporting on progress, conducting formal presentations, strategic planning, change management, project planning, risk management, change management
Full Job Description
The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Serve as primary point-of-contact and primary escalation point to the client Coordinate and oversees all functional services including external vendors to the established timeline and budget Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i. e. number of sites), Sr. PM may assume all clinical activities Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation Establish tracking metrics to monitor trial and team progress towards project goals Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise Leads both internal and client
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