Clinical Trial Manager/ Clinical Project Management

Clinical Trial Manager/ Clinical Project Management

 

We have an urgent need for Clinical Trial Manager/Project Management position for a small CRO in Cedar Knolls, New Jersey

 

Organizational and Project Management Activities:

 

Serve as clinical project lead initiating and leading project team meetings; depending on type of trial, may participate in project team meetings as a subordinate to the Trial Launch Project Manager during the Investigator recruitment, registration and training (Start-Up) phase of a project

Serve as leader of the DHC project team from Conduct through Close Out phase for all types of trials assigned

Participate in Sponsor and Investigator meetings as required

Participate in protocol review and contribute to development of Investigator training materials and study site registration documents in support of Trial Launch Services team activities

Assist in regional CRA selection and manage external CRA team; prepare materials and tools for CRA training and management

Assist in the project specific initiation, orientation and training of inter-departmental project team members as needed

Liaise and negotiate grants with academic/institutional study sites and central and local Institutional Review Boards (?IRBs?)

Manage assigned project-specific trial execution tasks, including direction and supervision of subcontractors

Monitor project status and issue status reports to management and Sponsor representatives

 

SOPs, File Management, Grant Payments and Inter-Departmental Activities:

 

Maintain currency of Standard Operating Procedures; review and update twice annually as needed and ensure that the project team members are fully trained on SOPs applicable to Sponsor?s contractual deliverables

Supervise the set-up, filing, and scanning of Project and Investigator Trial Master Files (?TMF?)

Track investigator payments in accordance with contractual requirements and trigger the investigator payment process by Finance

Up to 10% travel (air, ground and overnights)