Associate Project Manager, Clinical Affairs

Reva Medical LLC•San Diego, CA

1d•$70,000 - $85,000•Onsite

About The Position

The primary role of an Associate Clinical Affairs Project Manager within REVA Medical will be to support the operation and execution of domestic and international clinical trials.

Requirements

Bachelor's degree or equivalent experience.
Minimum of 5 years medical device clinical trial experience.
Prior experience with Class III implantable devices.
Peripheral artery disease product and clinical procedure experience.
Ability to evaluate and have a basic understanding of peripheral artery angiograms and duplex ultrasounds.
Excellent written and verbal communication skills
Ability to communicate clearly with project team members and Sr. Management
Ability to use Microsoft Office
Excellent organizational skills

Responsibilities

Assist in the management of clinical investigator sites, Clinical Resource Organizations (CROs), suppliers, clinical trial support staff and data management resources to optimally execute established clinical research plans in achieving high caliber clinical research.
Assist in ensuring overall initiation, development, implementation, and training of all clinical sites within the clinical program to ensure the integrity of the data collection process.
Perform monitoring of study data and regulatory binders at assigned clinical sites.
Oversee device accountability including shipments, returns and tracking across sites.
Coordinate with core lab and sites to ensure protocol-required imaging is submitted and tracked.
Coordinate with Safety Board core lab to collect and track adverse event source documentation in support of CEC meetings.
Assist in ensuring Trial Master File (TMF) for ongoing studies is populated and audit ready.
Provide input to study-specific protocols, Clinical Study Plans (e.g., TMF Plan, Monitoring Plan), and other study-related documents.
Provide input to Clinical Department QAPs and Work Instructions in support of clinical study execution.
Coordinate communication and submission documents with the ethics committee(s) and/or Institutional Review Boards as needed. This may include interface with country specific CROs for international submissions.
Assist in ensuring clinical study execution, clinical trial enrollment and follow-up data analysis are performed within company established timelines.
Support planning and execution of mock and Regulatory Body audits at Sponsor and site-level.