United States onlyCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder. Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives. Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary:
Senior Specialist, Platform Oversight is responsible for and supports clinical technology solutions at a program level and is the primary point of contact for the clinical operations team.
Key Responsibilities
- Under guidance/supervision of the Senior Clinical Oversight Manager, provides support on GxP-validated and non-GxP clinical technology solutions in accordance with Cerevel SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
- Acts as business administrator for portfolio level technology solutions such as managing user access and day to day administrative activities
- Liaises between the internal and external technology providers and Clinical staff to ensure mutual understanding with regards to technical requirements, timelines, system functionality, system capabilities, and new product developments
- Elicit and document technical software requirements from end users and create detailed business process specifications to communicate Clinical’s technical requirements to designers, developers and contractors
- Execute performance qualification (PQ) and user acceptance testing (UAT) of clinical technology solutions and provides the initial support of these applications when moved to production
- Manage the development and execution of testing configuration changes as part of Computer Systems Validation change control management
- Support clinical study teams in the review and execution of UAT scripts for study-level clinical technology solution implementations and modifications
- Manage updating and creation of SOPs impacted by technology changes
- Build and export reports from clinical technology solutions to support metrics review programs or end users’ needs
- Represents Clinical Oversight on the cross-functional clinical study team and other project teams; interacts with internal and external groups
- Execute other oversight related activities as requested
Required Qualifications
- Minimum of 5 years relevant industry experience and at least 2 years of involvement with GxP-validated clinical technology solutions. Alternatively, must have proven experience in all primary job functions
- 1 year of clinical study experience with global clinical studies
- Experience in oversight of clinical technology vendors
- Required experience with clinical technologies, such as: Veeva Vault eTMF
- Documented training, knowledge, and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
- Ability to read, write, and speak fluent English
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
Desired Qualifications
- Preferred experience with clinical technologies, such as: Interactive Response Technology (IRT), Risk Based Quality Management (RBQM), and/or Electronic Data Capture (EDC)
- Clinical oversight or quality experience strongly preferred
- Desire to work in a fast-paced, dynamic environment
- Strong data analytics skills preferred
- Detail-oriented and organized
- Excellent communication and presentation skills
Education
- Minimum of a bachelor’s degree in a life science or a health-related field
- Relevant professional certifications a plus
