Senior Project Manager - Oncology

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 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, investigative staff, 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    

Qualifications:    

Minimum Required:    

North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred  

EU: Degree or equivalent combination of education/experience in science or health-related  field. Advanced degree preferred  

Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience    

Experience in managing complex and global trials  

Ability to travel domestically and internationally including overnight stays    

Other Required:   

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    

Competencies:    

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    

Preferred: experience with oncology & cell and/or gene therapy

#LI-KH1 #LI-Remote

 

 

 

  Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $147,300 — $220,900 USD

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