What are the responsibilities and job description for the Senior Clinical Operations Manager position at SiteOne Therapeutics Inc?
Job Title : Senior Clinical Operations Manager
Location : South San Francisco, CA (Remote / Hybrid)
About SiteOne Therapeutics
SiteOne Therapeutics specializes in developing innovative treatments for hypersensitivity disorders affecting the nervous system, including pain, cough, and epilepsy. We prioritize scientific excellence, teamwork, and a steadfast commitment to transforming patient care. Currently, we are seeking passionate individuals to join our team, with hybrid and remote work options available.
Key Responsibilities
- Oversee clinical operations to implement assigned clinical trials according to company objectives.
- Manage clinical studies and partnerships with vendors to ensure successful completion on time and within budget, adhering to SOPs, FDA regulations, and ICH / GCP guidelines.
- Identify and cultivate relationships with clinical CROs and study providers to facilitate effective trial execution.
- Participate in the creation and review of critical study documentation, including protocols, informed consent forms, and case report forms.
- Review monitoring reports and ensure accurate documentation is maintained in the Trial Master File (TMF).
- Lead study management team meetings, collaborating with various departments to align on clinical study objectives.
- Track team assignments and proactively address any issues that arise.
- Conduct site visits, both in-person and remotely, for training and monitoring as necessary.
Qualifications
