Senior Manager of Clinical Studies

Clinical/Research               ·              Mountain View, CA              ·               Full time

Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source.

At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.

We are currently seeking a Senior Manager of Clinical Studies to join our team. This individual will provide oversight of IDE clinical study development and execution, data monitoring, and data management. The fundamental responsibilities of the position are to ensure the successful execution of clinical studies and appropriate uses of the data. The person in this role must have proven leadership capabilities, have extensive project management experience, and possess readily accessible knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials as they relate to use of a class III medical device.

Key Responsibilities

Clinical Trial Execution And Oversight

• Oversee implementation of IDE clinical studies to ensure the timely, accurate and cost-effective execution of study protocols from conception through final clinical study report.
• Establish the clinical study compliance vision and work with clinical study and monitoring teams to ensure inspection readiness and compliance to FDA regulations, ICH-GCP requirements and quality standards, internal procedures, and operational best practices.
• Oversee contract and budget negotiations with clinical sites; manage study costs and Support clinical study recruitment efforts, including internal and vendor managed efforts.
• Provide mentorship and direct supervision of clinical study management, data monitoring, and data management team members, including performance management and development planning.
• Establish and maintain effective communication and collaboration with cross functional teams, including Regulatory Affairs and Quality Assurance, Finance/Accounting, HR and senior management in order to meet organization objectives and support the achievement of goals.
• Coordinate with regulatory affairs to meet FDA submission requirements, to develop key clinical documents (including protocols, amendments, annual reports) and participate in the preparation and execution of meetings with regulatory authorities.

Clinical Data Management

• Lead development of study data management and monitoring documents, procedures, plans (data management plans, data monitoring plans, study audit plans, data analysis plans, risk assessment and categorization tools, errata) and corresponding training materials
• Supervise clinical data management employees, including Electronic Data Capture (EDC) System vendor relationships.
• Develop strategic plans to integrate and align the timing of clinical trial data locks with the release of key data points for scientific meetings and marketing materials.
• Work cross-functionally to create and maintain intuitive methods of clinical and device related data collection, assimilation, interpretation and reporting.
• Ensure the highest data integrity, that the data needs for all teams are met, and that data analysis and presentation are consistent across the company and within publications.

Requirements

• Bachelor’s Degree in relevant life science field required. MS preferred; Clinical research/trial management certification preferred.
• Minimum 10 years previous experience overseeing medical device clinical study execution and study personnel.
• Strong desire to lead projects and people and engage in significant hands-on work.
• Thorough knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812, FDA Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013), ISO 14155 Second Edition 2011-02-01, ICH GCP E6/FDA guidance, HHS Common Rule
• Experience with implementing and managing complex and integrated clinical systems to drive data integrity and efficiency (systems include EDC, CTMS, eTMF, and CRM systems).
• Strong time management, organization, interpersonal, verbal, and written communication skills with a high degree of accuracy and attention to detail.
• Proficient (expert user) in MS Office applications
• Up to 20% domestic travel required.

Benefits

• Medical, Dental & Vision Insurance
• Voluntary Life
• 401K
• RSU
• 529 plan
• ESPP Program
• Health & Wellness Program
• Generous Paid Time Off plus eleven paid holidays
• FSA & Commuter Benefits

NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable)

PRIVACY NOTICE:  NeuroPace takes its responsibility to protect your personal information seriously, and it uses reasonable safeguards to avoid unauthorized use or disclosure of it, and inadvertent loss or impermissible alteration of it.  NeuroPace complies with all applicable federal and state laws and regulations that govern the handling of your personal information.  If you would like more detailed information on NeuroPace’s privacy policies, please refer to neuropace.com/privacy/ for reference.  NeuroPace retains candidate resumes and applications in its files for future reference and/or consideration for other available job postings.  If you do not wish for your resume and applications materials to be retained in NeuroPace files, or wish to obtain a listing of any personal information that NeuroPace has stored about you, please contact us at privacy@neuropace.com. 

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