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Senior Clinical Trial Manager, LUMUS Program
2 months ago
We are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team. The successful candidate will be responsible for ensuring the successful execution of clinical studies to the highest quality standards.
Key Responsibilities- Manage all day-to-day operations of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables.
- Oversee and manage vendors, junior staff, and contractors, with a focus on delivering results within a 1-2 year horizon.
- Coordinate cross-functional study team members to ensure initiation and execution of the clinical study deliverables within approved budget and timelines.
- Provide recommendations in vendor identification/qualification/selection and oversight with proven track record of successful execution and study completion activities.
- Contribute to or lead the systems set-up/management including EDC, IWRS, Central Laboratories, specialty services.
- Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
- Effectively track and communicate program/study progress to Portfolio/Program Directors and Senior Management.
- At least 8 years of relevant experience in clinical operations, with experience in both early and late phase of development preferred.
- Comfortable with travel and able to travel up to 25% of the time as needed.
- Demonstrated experience in core and technical aspects of initiating and managing phase 1-4 clinical trials.
- Demonstrated experience in management of sites, CROs and vendor selection.
- Excellent interpersonal and communication skills, with developing leadership attributes.
- Success working in a matrixed environment.
- Demonstrated experience in the application of US and Global Regulations and Guidance.
- Proficiency in Microsoft Office, electronic TMF, and electronic clinical technologies.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. We are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team.
This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.
The salary range for this position is $180,000 USD to $195,000 USD annually.
