Job Description

Job title: Sr Clinical Trial Manager

Location: South San Francisco, CA (Remote/Hybrid)

About Us

About SiteOne

SiteOne Therapeutics is a biopharmaceutical company developing treatments for hypersensitivity disorders of the nervous system such as pain, cough and epilepsy. Our values are scientific rigor, intensity, teamwork and commitment to our shared mission of developing transformative medicines for the benefit of patients. Our drug candidates are exquisitely selective modulators of ion channels, and are under investigation by both systemic and local routes of administration. An opportunity is currently available for a talented and motivated individuals to join our team. Hybrid and remote options are available.

Key Responsibilities

We are seeking an accomplished and results-driven Senior Clinical Trials Manager who will be responsible for:

• Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.
• Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines.
• Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., central labs, study specific vendors, independent contractors) to execute clinical trials.
• Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, informed consent forms, case report forms, and study guides/manuals.
• Reviewing monitoring reports and other study documentation as required.
• Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
• Lead study management team meetings and collaborate with other functional groups within the company (e.g., Clinical Research, Biometrics, Clinical Supply, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
• Following up on assigned team action items and identification, escalation, and resolution of issues as needed.
• Conduct in-person or remote site visits (e.g., training visits, site initiation visits, monitoring visits), as required.

Qualifications

BA/BS required with a minimum of 6 years of industry experience in clinical operations within the biopharmaceutical industry:

• Experience in managing Phase 1-3 clinical studies that relies on clinical outsourcing
• Leading internal and external teams, including CROs, vendors, and consultants
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Must display strong organizational, analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions
• Strong communication and influence skills and ability to create a clear sense of direction
• Ability to deal with time demands or unexpected events and escalate, when appropriate
• Knowledgeable of FDA, EMA, ICH and GCP regulations and guidelines
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Ability to travel as required for the program (25%)

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