Senior Clinical Project Manager/Clinical Project Manager

Pfm; Hong Kong; On-site; HKD 600,000 - 800,000; Full time

Job summary

Pfm is seeking a Senior/Project Manager in Hong Kong to oversee clinical study projects. You will manage project timelines, budgets, and quality standards while acting as the main client liaison. The ideal candidate should have significant experience in clinical research and project management.

Strong skills in Microsoft Office and project management tools are essential. A degree in a relevant field is required, with advanced qualifications preferred. Opportunities for travel may occur as part of the role.

Qualifications

• 3-7 years of clinical research experience.
• 2-4 years of project leadership experience.
• Experience managing regional and global trials.

Responsibilities

• Manage clinical study projects ensuring quality, scope, cost, and time.
• Serve as primary point-of-contact for clients.
• Develop comprehensive project plans with risk management.

Skills

Clinical research management

Microsoft Office Products

Excellent communication skills

Attention to detail

Project management techniques

Cross-functional teamwork

Education

Degree in science or health-related field

Advanced degree preferred

Tools

Microsoft Project

eTMF

EDC

CTMS

Job description

Position Summary:

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. PM will either manage regional trials (moderate complexity) and/or support the role in managing complex global trials.

Essential Functions:

• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversee all functional services including external vendors to establish timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out-of-scope activities are identified early and handled appropriately
• 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 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
• 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 organisational 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

Qualifications:

• Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 3-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project
• Experience managing regional trials (moderate complexity) and/or 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

Competencies:

• 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

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