Clinical Trials Manager
San Francisco, California /
Data & Analytics /
Full-time /
Work at Lever
Lever builds software for teams to source, interview, and hire top talent. Our team strives to set a new bar for enterprise software with modern, well-designed, real-time apps.
We are seeking an experienced Clinical Trial Manager (CTM), to join our growing Clinical Development Organization. This role will be key to leading the planning, execution and oversight of clinical trials within our Rare Disease programs. The position will entail managing all aspects of trial operations (from study launch to study close) while ensuring quality in accordance with GCP, ICH, and other guidelines. This role is responsible for internal cross-functional study team activities, as well as external communication and oversight of vendors (e.g., CROs, Central labs, etc.). As the key leader overseeing trial activities, the CTM builds strong relationships to facilitate integrated team functionality across all vendors, sites, and study team members. Representing clinical operations on the program team, the CTM is responsible for adhering to timelines and milestones of study goals as well as identifying and communicating risks to the team.
Responsibilities
- Ensures appropriate oversight of Contract Research Organizations (CROs), clinical trial sites and other external vendors, including assessment of performance against contractual obligations.
- Leads development, distribution and execution of operational activities outlined in various study plans, SOPs, study procedures, etc. including management of critical study documents (i.e. ICFs, study plans, site materials, etc.)
- Builds solid relationships with key counterparts at CRO(s) and other external vendors
- Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
- Through oversight of the CRO, drives start-up, enrollment, clinical monitoring activities, clinical site compliance and tracks metrics from CROs, central labs, and other external vendors
- Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports, conducting co-monitoring visits at clinical sites as needed, reviewing data listings or profiles at specified timepoints)
- Representing clinical operations as part of a cross-functional internal team Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables; appropriately escalates risks to the Program Team
- In partnership with QA, supports and participates during vendor selection and audit activities
- In partnership with finance, provides input to the development of study-level budget(s)
- Demonstrates accountability for the management of assigned clinical study budget(s) through review of study-level scopes of work, invoices, and change orders in accordance with the evolving needs of the study
- Anticipates, recognizes, and manages issues while exhibiting the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management; applies appropriate preventative and corrective actions.
- Drives quality efforts to proactively identify and manage risks to trial quality and ensure inspection readiness
- Partners with Clinical Supply and Technical Operations to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destruction
The Lever Story
We participated in Y Combinator in summer 2012, and since then have raised $40 million. This year, we’re doubling the team in size, and we’re looking forward to supporting more great companies like Netflix, Eventbrite, and Lyft. Interested in learning more? Take an inside look at Lever!
Lever is proud to be an equal opportunity workplace dedicated to pursuing and hiring a diverse workforce.
