Clinical trial oversight ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management.
28th July, 2020
Senior Clinical Trials Manager - San Diego (will work remote until COVID restrictions are lifted, but must be local to San Diego)
The Senior Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role: external vendors (including bioanalytical and safety laboratories, drug depots and full-service CROs. The position reports to the Chief Development Officer and is accountable to the Clinical Operations Lead for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
Communication to internal team members on deliverables and ensuring timelines are met
Manage trial feasibility process
Work closely with study Clinical Operations Lead to execute clinical studies.
Drafting or reviewing (if prepared by the CRO) site materials including training, manuals and support documentation.
Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
Periodic review of clinical data
Review of clinical monitoring reports to ensure timely completion and identification of issues
Ensure laboratory samples are ready to be sent to vendors in order to meet trial deliverables; ensure all contracts are in place, and any required data transfer agreements are completed before any data transfers are needed
Maintain trial metrics
Ensure trial is conducted in accordance to client and ICH/GCP standards including multiple regions in global trials
Support testing clinical trial systems/databases (i.e. UAT)
Develop and maintain strong, collaborative relationships with key stakeholders within company
Work collaboratively with all outside vendors and company consultants to achieve timelines; maintain a partnership with the primary CRO on each study to ensure all are working towards the same goals.
Help prepare for and attend Clinical Advisory Board meetings
Ability to interact effectively with Key Opinion Leaders
Understand when issues need to be escalated to ensure timelines are met
8-10 years of experience working in a clinical operations role (CRA, Clinical Trial Assistant); some experience working for a Sponsor preferred
At least 5 five years of trial management experience in a clinical research environment (Sponsor); early to mid-phase in both patients and healthy volunteers.
Experience working on rare disease or vaccine studies (ideally Phase III experience in vaccine studies)
Advanced degree preferred or Bachelor’s in a science-based subject
Relevant experience in global setting
Solid understanding of drug development
Good project management skills
Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Excellent verbal and written communication skills
Good organizational skills and attention to detail