You will provide project management and leadership to plan, prepare and execute high quality clinical trials. You will ensure that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.
Your Main Responsibilities and Duties Include:
- You are responsible and accountable for multiple clinical trials and manage each project within defined timelines. You coordinate/execute of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
- You will facilitate investigational site budget negotiations.
- You will provide regular updates to TI staff, Sponsors, vendors and contract staff concerning status and progress of the trial.
- You will facilitate protocol development as needed.
- You are responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring tools, monitoring plans, close-out plans.
- You are responsible for ensuring the trial is "audit ready" at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). You ensure that any audit observations are addressed appropriately and in a timely manner.
- You are responsible for ensuring that project team members are compliant with TI SOPs and internal guidelines.
- You will assist with training and supervising CRAs.
- You will develop presentations, handouts and coordinate investigator meetings and make effective oral and written presentations.
- You will perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
- You are responsible for reviewing and approving all monitoring reports and correspondence with sites from CRAs.
- In regards to Data Management: You will perform SAP and DMP review, edit specifications review, and ensure query monitoring and resolution, review of data listings and clinical study report, as needed.
To Succeed in this Position:
- You should have a Bachelor's-level degree in science/health related field or a combination of education and industry experience. A Master's degree is preferred.
- You should have 5 to 8 years of clinical research experience with at least 5 years of clinical trial project management experience. Prior CRO experience preferred.
- You should have a thorough understanding of GCPs and FDA and ICH guidelines.
- You should have excellent written and oral communication skills with the ability to manage multiple priorities with high attention to detail.
The most likely base pay range for this position is $110,000 - $145,000 per year. Several factors, such as experience, location, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.
**Candidates based in San Diego are preferred and would be required to be onsite per our company's hybrid schedule.
Remote candidates will be considered but are required to come to the San Diego office upon hire, at year-end annual training and as needed. Will be discussed during interview process.
