Clinical Study Manager Jobs in Riverside, CA (NOW HIRING)

About the Role

Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs.

This role will be focused on the development of clinical strategies for assigned programs and is responsible for ensuring effective and efficient execution of the clinical development plan.

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

• A leader with influence to present and collaborate with cross-functional team members to synthesize clinical data.
• Primary author for assigned clinical trial protocols, collaborating with and leading with other functions required for protocol development.
• Contributes or reviews clinical, regulatory, and relevant study documents, including Investigator Brochures, Clinical Study Reports, Statistical Analysis Plans, Operation Manuals, Investigational New Drug Applications/Clinical Trial Applications, case report forms, and data tables listings and figures.
• Educates internal and external team members on protocol execution.
• Primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors, regarding study protocol, informed consent, and patient-specific questions.
• Reviews, finalizes, and updates information/data entered in clinical trial registries.
• Participates in development of Clinical Development Plan.
• Partners with data management on resolution of all clinical queries to sites.
• May participate in health authority interactions, as well as interactions with site Institutional Review Boards/ethics committees.
• Contributes to scientific abstracts for submissions to scientific conferences and publications for peer-reviewed journals.
• Creates, reviews, and/or presents clinical slides for internal meetings and external forums.
• Collaborates with biostatistics to develop data tables, listings, and figures.
• Identifies and tracks any potential safety events within a given study, or across studies for assigned programs.
• Conducts medical data review.
• Provides clinical development input to proposed revisions of SOPs and guidance documents.

Factors for Success:

• Advanced clinical/science degree preferred (PharmD, PhD, OD, MD).
• 10+ years minimum experience, with 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist) and 5+ years of experience with clinical trials. Eye care experience preferred.
• Experience authoring clinical trial protocols and/or study results and conclusions, applying creative thinking and adaptability for early development programs
• In-depth understanding of drug development.
• Working knowledge of basic biostatistics
• Experience working with techniques of data analysis, interpretation, and assessment of clinical relevance.
• Well-versed in medical aspects of Good Clinical Practice, International Council for Harmonization, Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence and other relevant guidelines and regulations.
• Has demonstrated, through past experience, abilities to competently manage the majority of clinical science deliverables associated with assigned clinical studies.
• Strong presentation skills: effective at summarizing and presenting the key considerations and decision points.
• Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.
• Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end results.
• Able to work in a fast-paced dynamic organization.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
• Tarsus Competencies:
  • Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there's not a blueprint for success. Owns their decisions and actions.
  • Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
  • Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met. 

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• 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 the COO.
• Some travel may be required - up to 50%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $165,000 - $231,000 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. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

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