Associate Clinical Project Manager

Empresa: Deciphera Pharmaceuticals
Tipo de empleo: A tiempo completo

Job Description
We are seeking an ASSOCIATE CLINICAL PROJECT MANAGER to support the management of clinical trials from initiation to completion while partnering with internal and external cross-functional disciplines.
This position will report to the DIRECTOR OR ASSOCIATE DIRECTOR, CLINICAL OPERATIONS and be located in the Waltham, MA office.
KEY RESPONSIBILITIES:
Maintain study trackers and tools as directed by the CPM
Maintain study contacts list
Support site payments
Assist study team with preparation for audits/inspections
Assist in creating, editing, and distributing informed consent templates and other study documents
Support site start-up activities
Track 1572s and liase with Regulatory for IND submission as well as other essential documents as appropriate
Assist with Investigator Meeting Planning and may present at the meeting
Maintain study FAQ list
Assist with sample management
Perform quality control review of documents
Submit documents to the TMF
Perform TMF QC
Assist in Essential Document Packet (EDP) review and approval
Assist with resolution of vendor and investigational site data queries
Provides input and coordinates the delivery of clinical trial supplies
May perform SIVs
May provide study-specific training to vendors, CRAs and site staff
May manage 3rd party vendor as directed by the CPM
May participate in review of study core documents (protocol, IB, CSR)
May develop and maintain study documents
Able to work in a fast-paced environment