Senior Manager, Clinical Operations
At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.
Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!
The Senior Manager, Clinical Operations will manage clinical trial delivery according to Standard Operating Procedures, ICH GCP and regulatory guidelines. They will interact primarily with Clinical Development, Pharmacovigilance, Regulatory, Data Management and Biostats, but also liaises with other functional groups to maintain and develop systems which promote regulatory compliance, enhance efficiency, and achieve organizational goals. The Senior Manager, Clinical Operations will also be accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment.
- Help facilitate study team meetings including Study Kick-off meeting, and may attend other higher level team meetings
- Provide required data from studies and sites to comply with regulatory and government requirements (GDPR, Human Subject Protection training, Clinical Insurance, etc.)
- Participate and oversee the preparation and ongoing review of Regulatory and Study documents
- Support and collaborate with the Clinical and Regulatory Documents team in achieving its departmental goals
- Responsible for Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management
- Responsible for input into study timelines, risk registry, operational logistics and assess study progress against KPI's and generate trend reports
- Responsible for oversight of setup and maintain Clinical systems and tracking tools (e.g. CTMS, eTMF and other Controlled Document systems)
- Oversee ongoing document review and collection into the TMF throughout study start-up, maintenance and close-out periods
- Collaborate with Regulatory, Quality and other departments as necessary to ensure appropriate oversight of TMF and the collection and filing of supporting Regulatory documents
- Manage and oversee the coordination of study start-up activities (site feasibility, site selection, essential document collection/review, budget/contract negotiations, site activation, clinical trial registration, trial insurance, etc.)
- Manage Investigational Product Management (labelling, packaging, shipping, temperature excursions, accountability/reconciliation, destruction)
- Manage monitoring or co-monitoring visits and trip report review according to Clinical Monitoring plan
- Ensure and oversee tracking of subject status throughout the study at investigative sites through collaboration with data management by monitoring subjects’ safety trends and alerts, and protocol deviations (track, report, follow-up)
- Responsible for data integrity and accuracy throughout the Clinical Trial lifecycle
- Assure appropriate oversight for collection and tracking clinical samples from clinical sites to central labs and vendors
- Assist in managing the study budget, forecast, reconciliations and task order changes
- Coordinate meetings between Vendors, Contract CRAs, and Investigative Sites, as needed
- Assist with external data reviews and database lock activities
- Manage the coordination of site close-out activities (monitoring, reconcile/archive TMF, reconcile & dispose of IP and biological samples, vendor financials, update clinicaltrials.gov, etc.
- BA/BS degree or higher, preferably in life sciences with 5 years of relevant experience
- Experience in CNS preferred.
- Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
- Able to evaluate work performed against Scope of Work (SOW) documentation and lead portion of study tasks
- Excellent oral and written communication skills required with the ability to effectively understand and present information and deal confidently with internal and external stakeholders
- Initiative, excellent attention to detail, with highly developed organizational, and time-management skills are required
- Anticipates and proactively identifies, recommend creative solutions or escalate issues for project resolution.
- Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook)
- Prior experience with eTMF, CTMS and EDC systems preferred
- Travel may be required but is not expected to exceed 25%
Company benefits include:
- Medical, dental, vision, and life insurance
- 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
- New hire stock options
- Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
- Leave of Absence: Paid family leave, paid short- and long-term disability
- Discretionary year-end bonus
- The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $167,603- $176,730
Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.