Precision for Medicine
SeniorProjectManager
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“Senior Project Manager at Precision for Medicine. Skills: Project management, Clinical research, Global trials, Risk management. Plan, direct, coordinate, and deliver activities for clinical. Serve as primary point-of-contact to the client”
What You'll Achieve.
Ensure project objectives of quality, scope, cost, and time are accomplished; Ensure project remains within scope; Support business objectives; Guide all parameters of trial execution with consistency and quality; Address any quality findings; Monitor trial and team progress towards project goals; Increases in productivity and efficiency
Industry & Context.
Risk management; Risk mitigation; Problem identification; Solution offering
Ability to travel domestically and internationally, Overnight stays
What They're Looking For.
Must Have
Bachelor’s degree or equivalent combination of education/experience in science or health-related field, Minimum of 7 years of clinical research experience, Minimum of 4 years of direct project management experience, Experience in managing complex and global trials, Experience with Microsoft Office Products, Experience with Microsoft Project, Experience with eTMF, Experience with EDC, Experience with CTMS, Proven communication and interpersonal skills, Proven organizational skills, Attention to detail, Customer service demeanor, Knowledge of ICH-GCP, Knowledge of relevant Precision SOPs, Ability to implement ICH-GCP and SOPs, Direct work experience in a global, cross-functional project management environment, Good understanding of cross-functional management, Good understanding of project planning, Good understanding of risk management, Good understanding of change management, Awareness of appropriate escalation, Proven experience in strategic planning, Proven experience in risk management, Proven experience in change management, High level of integrity, Ability to lead and inspire excellence within a study team, Ability to create an environment where study team members have a sense of ownership, Proven time management skills, Proven negotiation skills, Proven critical thinking skills, Proven decision making skills, Proven analytical skills, Proven interpersonal skills, Proven presentation skills, Proven verbal communication skills, Proven written communication skills, Good understanding of project management software, In depth proven experience in pharmaceutical and/or device research, Experience with Autoimmune Diseases, Experience with Oncology
Nice to Have
Advanced degree preferred
What You'll Do.
and deliver activities for clinical
Serve as primary point-of-contact to the client
Serve as primary escalation point to the client
Coordinate and oversee all functional services
Coordinate and oversee external vendors
Manage the study budget
Identify out of scope activities
Handle out of scope activities
Drive the CO to completion
Drive the CO to execution
Maintain integrated collaboration with clinical operations
Participate in clinical activities
Manage the financial health of assigned studies
Oversee project profitability
Oversee billable project hours
Ensure compliance with on time billing
Ensure compliance with accurate billing
Ensure compliance with forecasting
Develop comprehensive project plans
Develop project timelines
Develop proactive risk management plans
Develop risk mitigation plans
Ensure Quality management for assigned projects
Ensure eTMF Inspection readiness
Implement quality notification incident forms
Implement corrective and preventative action plans
Address quality findings
Maintain integrated collaboration with all functional operations
Review other study documentation
Establish tracking metrics
Monitor trial progress
Monitor team progress
Prepare project status updates
Report on progress to clients
Report on progress to senior management
Report on key performance indicators
Lead internal meetings
Set expectations for the project team
Communicate effectively with client
Communicate effectively with Precision management
Relay protocol/study issues
Relay study deviations
Implement necessary actions in response to issues
Conduct formal presentations
Ensure study specific training is implemented
Ensure study specific training compliance
Support business development activities
Support marketing activities
Perform other duties as assigned
Remain compliant with organizational training
Remain compliant with time-reporting
Remain compliant with administrative duties
Provide on-going feedback for functional team members
Provide annual performance reviews
How You'll Work.
Team & Collaboration
Cross-functional teams; Client collaboration; Senior management reporting; Functional team members
Communication Scope
Client communication; Management communication; Formal presentations; Verbal communication; Written communication
Process & Methodology
Project planning, Risk management, Change management, Strategic planning, Budget management, Timeline management, Quality management, Forecasting, Project profitability, Global trials 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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