Senior Clinical Project Manager, CRO Services

Job Description

POSITION SUMMARY:

The Senior Clinical Project Manager drives all aspects of clinical trial design and execution.

This role oversees design, start-up, execution and close-out of one or more multi-center clinical research studies, ensuring that studies are run in accordance with regulations and internal SOPs.

The Senior Clinical Project Manager may directly manage one or more multi-center clinical research studies and/or provide mentoring, training or peer oversight to Clinical Project Managers.

ACCOUNTABILITIES:

Coordinates, manages and performs activities related to clinical research projects:

• Manages study timeline, budget and deliverables

• Works cross-functionally to ensure all aspects of clinical studies are executed in accordance with ICH/GCP, regulations and SOPs

• May oversee new study budget creation and tracking of ongoing finances

• Uses operational and therapeutic expertise to optimize trial design.

Drives development and creation of study-specific documents and processes, including but not limited to protocol, informed consent, case report forms, investigator brochure and study plans.

• Oversees data intake and review to ensure early detection of data trends

• Educates self in new therapeutic areas, pursues education opportunities and seeks at all times to bridge gaps in knowledge

• Creates and/or streamlines processes to make an impact on the group portfolio of studies

• Able to problem-solve complex issues

• Works with finance and contracts to drive vendor agreements and oversight

• Creates metrics and audience-driven reporting to deliver key messaging for study outcomes and compliance

• Models professional demeanor for external stakeholders through pristine communication, knowledge of company and therapeutic area, and expertise in clinical research

• Nurtures key internal and external relationships to further NMDP/CIBMTR goals and patient outcomes

Leadership:

• Provides mentorship, training, and peer oversight, and escalates issues when appropriate

• Demonstrates senior-level capabilities of risk management and mitigation by anticipating clinical study issues and proactively implementing strategies to contain risks

• Creates and/or streamlines processes to make an impact on study portfolio

• Liaises with operational leaders to identify efficiencies, manage team priorities, and foster clear communication and expectations

• Oversees staffing and workflow to align with project timelines and goals

• Ensures staff are executing work in compliance to ICH/GCP guidelines and in accordance with internal SOPs

• Drives staff efficiency, productivity and engagement by understanding strengths, weakness and drivers

REQUIRED QUALIFICATIONS:

Knowledge of:

• HCT/Cellular therapy clinical trials preferred

• FDA regulations, GCP and industry best practices

• IND and/or IDE submission and reporting processes

• Structure and reporting requirements for gran...