Senior Clinical Project Manager - Hybrid/Remote

Please apply online using a laptop or desktop computer.

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.

This is a remote position (US).

#LI-Remote

Check out our video Saving Lives: It's the Best Job Ever

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.


* 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 outcome

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 pro...