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Tarsus Pharmaceuticals, Inc. · 1 day ago

Manager I, Clinical Trials

Orange County, CA

Full-time

Hybrid

Mid, Senior Level

$94K/yr - $131K/yr

5+ years exp

Tarsus Pharmaceuticals, Inc. is a company focused on innovative solutions in the pharmaceutical space. They are seeking a Manager I for Clinical Trials who will oversee key study activities, manage study documentation, and ensure compliance with clinical protocols.

BiopharmaBiotechnologyLife Science

Responsibilities

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

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

Qualification

Clinical research experienceICH/GCP R2 GuidelinesVendor managementMS Office proficiencyPrioritization skillsAttention to detailIndependent workCollaboration skillsFlexibility

Required

Bachelor's degree (life science preferred) and five years clinical experience or Associate's degree and 7 years clinical experience

Minimum of 2 years of clinical research experience at a Pharmaceutical, Biotech, or CRO company

Experience managing outside vendors (e.g., CROs and labs)

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

Benefits

Health, dental and vision insurance benefits

Generous paid time off, including vacation, holidays, and personal days

Company

Tarsus Pharmaceuticals, Inc.

Tarsus (NASDAQ:TARS) is a biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care.

Founded in 2017

Irvine, California, USA

201-500 employees