Senior Clinical Project Manager

Precision Medicine Group (New York, United States); United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Precision for Medicine is seeking a Senior Project Manager to plan, direct, and deliver clinical-study projects ensuring that project objectives of quality, scope, cost and time are accomplished. The PM will manage regional trials or support global studies, coordinating vendors to timelines and budgets and ensuring cross-functional alignment.

You will oversee study budgets, profitability, billable hours, and forecasting, and develop robust project plans with proactive risk management.

Qualificações

• Degree or equivalent in science/health field; advanced degree preferred.
• 3–7 years of clinical research experience; 2–4 years of leading a project.
• Experience managing regional trials or supporting complex global trials.
• Experience with Microsoft Office, MS Project, eTMF, EDC and CTMS.
• Strong communication, organizational, and customer-service skills.

Responsabilidades

• Serve as primary client contact and escalation point.
• Coordinate external vendors to timelines and budgets.
• Manage the study budget and out-of-scope activities.
• Ensure functional areas are aware of study scope and manage accordingly.
• Oversee profitability, billable project hours, and forecasting to support objectives.
• Develop robust project plans with timelines and risk mitigation.
• Ensure quality management including eTMF readiness and CAPAs.
• Maintain collaboration across functional operations and study documentation.
• Establish tracking metrics for progress toward goals.
• Prepare status updates and report to clients and management.
• Lead internal and client meetings and set expectations.
• Communicate protocol/study issues and implement corrective actions.
• Ensure study-specific training and training compliance.
• Travel domestically and internationally as needed.

Conhecimentos

Communication

Interpersonal skills

Organizational skills

Attention to detail

Customer service

Formação académica

Bachelor's degree in science/health field

Advanced degree preferred

Ferramentas

Microsoft Office

Microsoft Project

eTMF

EDC

CTMS

Descrição da oferta de emprego

Location: China

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary:

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical-studyprojects to ensure that project objectives of quality, scope, cost, and time are accomplished.

PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. The essential functions below will describe the PM acting in a primary / lead PM role on a study. When in a supportive role on a global study, the essential functions will be delegated by the Global Lead.

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.
• 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 implements 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
• Provides on-going feedback for functional team members including annual performance reviews
• Ability to travel domestically and internationally including overnight stays

Qualifications:

Minimum Required:

• 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

Other Required:

• 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

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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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 [e-mail].

Candidates must be legally authorized to work in the country of employment without employer sponsorship.