About This Role
This role involves planning, directing, coordinating, and delivering activities for designated clinical study projects to ensure that quality, scope, cost, and time objectives are met. The role can involve managing regional trials of moderate complexity or providing support in managing complex global trials. The essential functions described are for a primary/lead Project Manager role, with tasks delegated by the Global Lead when in a supportive capacity on a global study.
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 the project remains within scope and that any out-of-scope activities are identified early and handled as appropriate
- Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly
- Manage the financial health of assigned studies, including oversight of 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
- 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, including any deviations, and implement necessary actions in response to those issues
- 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 Defence meetings as required
- Perform other duties as assigned by management
- Remain compliant with organizational training, time-reporting, and any other administrative duties as required
- Provide ongoing feedback for functional team members, including annual performance reviews
- Ability to travel domestically and internationally, including overnight stays
Requirements
- Degree or equivalent combination of education/experience in a science or health-related field
- Minimum of 4-7 years of clinical research experience or proven competencies for this position
- Minimum of 2-4 years of leading a project
- Experience managing regional trials (moderate complexity) and/or a supportive role in managing complex global trials
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS
- Good communication and interpersonal skills to effectively interface with others in a team setting
- Good organizational skills, attention to detail, and a customer service demeanor
- Mandarin speaking, as this is required to cover the East Asia market
- Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
- Working knowledge of project management techniques and tools
- Experience working in a cross-functional project management environment
- Fundamental understanding of cross-functional management
- Fundamental understanding of project planning, risk management, and change management with an awareness of appropriate escalation
- 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
- Good time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills
- Good presentation, verbal, and written communications skills
- Fundamental understanding of project management software
- Experience in pharmaceutical and/or device research required
Nice to have:
About the Company
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease.
