Manager II, Clinical TrialsIrvine, California, United States

Manager II, Clinical Trials

Hi Tarsan!

Thanks for your interest in this position. Please review the details and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better.

- Your Human Resources Team

About the Role

Let's talk about some of the key responsibilities of the role:

• Oversees and manages key study activities including study start-up, development of study plans, vendors, drug inventory, lab supplies, non-clinical study supplies, lab sample management, and screening and enrollment activity.
• Involved in the review of protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms, and any other study-related documents as assigned; participates in user acceptance testing for eCRFs and recommends operational changes as required.
• Develops key study documents: training materials, site study materials, and related study documentation.
• Assists in the identification, selection, and site qualification processes of study sites.
• Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study; help train the study staff in conducting the study per GCP and in performing procedures per protocol.
• Arranges and oversees site visits.
• When monitoring has been delegated to a CRO, provides Sponsor oversight of monitoring activities and attends monitoring visits.
• Organizes and makes presentations at site initiation visits and/or Investigator Meetings.
• Manages and tracks all drug supply inventory (e.g., storage, distribution, site inventory, etc.) and updates supply tracking with projection vs usage.
• Reviews study budgets and tracks, processes, and manages vendor invoices in support of study financial tracking.
• Assists in the creation of project tools, tracking tools, etc. to report and oversee study specific metrics as needed.
• Reviews and assists in the preparation of Clinical Study Reports (CSRs).
• May serve as a resource for others within the company for clinical trials management expertise.
• Develops study timelines from start to finish including interim analysis timelines.
• Managing study finances and forecasting with program management.
• Works cross-functionally to report on study status, strategy, risks, finances etc to management.

Factors for Success:

• Bachelor's degree (life science preferred)
• Minimum of 8 years of clinical research experience at a Pharmaceutical, Biotech, or CRO company with strong proficiency on a global scale and early developments.
• Minimum of 2 years as a clinical trial manager in eyecare industry.
• Minimum of 2 years of vendor management experience (e.g., CROs and labs).
• Minimum of 1 year site monitoring experience including qualification, initiation, monitoring and close out visits.
• Thorough knowledge of ICH/GCP R2 Guidelines and working knowledge of health authority requirements and regulations.
• Demonstrated ability to attain and maintain a working knowledge of applicable Standard Operating Procedures at Tarsus and with CRO/vendors.
• Ability to work independently as well as collaboratively in an efficient manner.
• Skillful in prioritizing workflow with different demands to meet deadlines in an accurate and timely manner.
• Flexibility to adjust to changing needs in the Clinical Department and organization.
• Excellent knowledge of MS Office, Excel, and PowerPoint
• Strict attention to detail.

A Few Other Details Worth Mentioning:

• The position can be remote or based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. If in house, we provide a hybrid work environment.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Associate Director, Clinical Operations
• Some travel may be required up to 30%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $116,200 - $162,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.