ID
#44703210
Job type
Permanent
Salary
$130,000 - $200,000 per year
Source
Jobot
Date
2022-08-07
Deadline
2022-10-06

Clinical Project Manager

California, San diego, 92101

Permanent

Vacancy expired!

Great Pay! Yearly Bonus! Excellent Company Equity ! Competitive PTO! 401K Match! Full Benefits!

This Jobot Job is hosted by: Juan CorreaAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $130,000 - $200,000 per year

A bit about us:

We are a clinical stage biopharma targeting untreatable age-related metabolic disease.

Why join us?

Great Competitive Base Salary!
Yearly Bonuses! Stock Options!
Competitive PTO!
401K Match!
Full Benefits!

Job Details

Clinical Project Manager Job DescriptionOur growing company is looking to fill the role of Clinical Project Manager. The candidate selected for this position will function in a cross-functional team environment with primary responsibility of providing management and guidance to support the execution and completion of late-stage clinical trials. The candidate will also ensure compliance to quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, including proactively maintaining cognizance of current Google Cloud Platform standards.Responsibilities of the Clinical Project Manager

Contribute to the study and/or site budget development, and protocol outline development
Review the clinical study protocol and supporting documents- Statistical Analysis Plan, CRFs, Data Management Plan, Clinical Study Report, monitoring plan, communication plan, timeline, to ensure seamless integration between clinical objectives and study performance
Oversee the site feasibility and qualification process for identification of qualified investigational sites per protocol requirements
Serve as the liaison and/or Subject Matter Expert when defining the scope for vendor and/or site contracts
Track & manage study contracts per their defined scope and budget
Prepare, review & quality control essential study documents and collate all in Trial Master File or confirm that CRO provides adequate TMF documentation
Perform study execution and status reporting activities
Interface with clinical data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
Assist in preparation of final clinical study reports and oversee study closeout activities
Create and execute project work plans and revise as appropriate to meet changing needs and requirements
Manage day-to-day operational aspects of a project and scope along with identifying resources needed and assigning individual responsibilities
Review deliverables prepared by team before passing to external parties

Qualifications for Clinical Project Manager

Bachelor's degree required and 5 years of related clinical experience or the equivalent combination of education and experience is required
Must have working knowledge of Clinical Trial Database software, Word, Excel and Powerpoint (working knowledge of MS Project or similar platform is a plus)
Ability to understand technical requirements of projects and effectively manage resources, vendors and test effort action plans, impact and resolution options
Good understanding of healthcare practices and clinical related applications, including clinical laboratory applications
Working knowledge of FDA/EMA regulations, current ICH Google Cloud Platform guidelines, and Clinical research process from Phase I through regulatory submission
Evidence of building relationships with and managing expectations of stakeholders at all levels and externally, to persuade on business benefits and gain acceptance to changes
Must be able to displays original thinking and creativity
Effective English written, verbal, presentation and communication skills in the area of technical/clinical applications

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Vacancy expired!

Report job