About the position
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 Defences 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 organisational training, time-reporting and any other administrative duties as required. Provides on-going feedback, for functional team members including annual performance reviews.
Responsibilities
- Serve as primary point-of-contact and primary escalation point to the client
- Coordinate and oversee 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 participate in clinical activities as appropriate
- Manage the financial health of assigned studies, including oversight of project profitability, billable project hours, and compliance with on time, accurate billing and forecasting
- Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation
- Ensure Quality management for assigned projects, including eTMF Inspection readiness and implementation of quality notification incident forms
- Maintain integrated collaboration with all functional operations in the delivery of the program
- 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
- Lead both internal and client meetings and set expectations for the project team
- Communicate effectively with client and Precision management to relay protocol/study issues
- Conduct formal presentations to a wide variety of audiences
- Ensure study specific training is implemented in collaboration with functional areas
- Support business development and marketing activities as appropriate
- Perform other duties as assigned by management
- Remain compliant with organisational training, time-reporting and any other administrative duties
- Provide ongoing feedback for functional team members including annual performance reviews
Requirements
- 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
- 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
- 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
Nice-to-haves
- Experience with oncology & cell and/or gene therapy
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
