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 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
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
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