Senior Clinical Projects Manager - Global Trials Leader

Precision Medicine Group; Northern (KY); Hybrid; USD 147,000 - 221,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Senior Project Manager to plan, direct, coordinate and deliver clinical study activities, ensuring quality, scope, cost and schedule objectives are met.

You will serve as the primary client contact, oversee global trials, manage budgets and vendor relationships, lead cross-functional teams, and drive risk management, training, and reporting to senior management. Domestic and international travel is required.

Qualifications

• 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

Responsibilities

• Serve as primary point of contact and primary escalation point to the client
• Coordinate and oversee all 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
• 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
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans
• Maintain integrated collaboration with all functional operations in the delivery of the program
• 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
• 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
• Ability to conduct formal presentations to a wide variety of audiences
• 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
• Provides on-going feedback, for functional team members including annual performance reviews

Skills

Client liaison

Budget management

Risk management

Cross-functional leadership

Communication skills

Presentation skills

ICH-GCP knowledge

Global trials experience

Travel readiness

Education

Bachelor's degree in science/health

Advanced degree preferred

Tools

Microsoft Project

eTMF

CTMS

EDC

MS Office

Job description

Precision Medicine Group is seeking a Senior Project Manager to plan, direct, coordinate and deliver clinical study activities, ensuring quality, scope, cost and schedule objectives are met.

You will serve as the primary client contact, oversee global trials, manage budgets and vendor relationships, lead cross-functional teams, and drive risk management, training, and reporting to senior management. Domestic and international travel is required.