Description
DESCRIPTION:Prepare SOP, Work Instructions, Communications and associated documents (Templates, Forms, etc) to support the clinical trial processes per Global and Local SOP requirements; Strong proficiency in the use of current software, including spreadsheets, basic Microsoft applications and Visio (process maps); Ability to work independently and to manage multiple tasks in a fast paced environment; Maintain timelines; Understanding of the clinical trial process and experience in the pharmaceutical industry.
Remaining SOPs to be adopted:
TMF - Investigator Initiation Package and Subsequent Regulatory Documents - Monitoring - Investigational Product - Policy on Compensation to Investigators in Clinical Studies - Policy on Conduct of Interim Analysis and Use of Data Monitoring Committees - Study Training MEDICAL DEVICES Re-evaluation needed; SOP needs revisions or a WI; New Communication/Training will be needed Data Management; IG needs to be converted to a WI and forms need to be converted to the new template and added.
SAFETY and REGULATORY:
As applicable PCH SINGLE LINE SOPS; Re-evaluate need based on new formatting requirements; Many of the Biostats SOPs have been drafted, but need to be converted to Work Instructions; Med Info SOP has been converted to WI and has been written, Global SOPs that are revised: As applicable Associated documents (WIs, communications, etc) require evaluation as well as Process Map revisions.
REQUIREMENTS:
Understanding of Good Clinical Practices (GCP) and clinical operations and previous experience working in a regulated environment; Familiar with formatting SOPs into standard templates. Able to work with teams and maintain project timelines.
SKILLS
MS Excel, MS Outlook, Good Clinical Practices (GCP)
Synectics is an Equal Opportunity Employer.