Job Description
- Job Description:
- 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.
- Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope, 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
- 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 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
- 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
- Benefits:
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
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