Clinical Oversight Lead

Company Overview
Cerevel 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:
Clinical Oversight Lead (COL) is responsible for and oversees study deliverables at a protocol level via internal and external resources and is the primary point of contact for the day-to-day operations team.

Key Responsibilities

• Under guidance/supervision of the Clinical Oversight Director, provides oversight on vendor execution of clinical trial activities in accordance with Cerevel SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
• Conduct oversight visits at trial sites
• Evaluates compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection
• Represents Clinical Oversight on the cross-functional clinical study team and other project teams; interacts with internal and external groups
• Manages the Trial Master file process across studies, including oversight of TMF plan, managing TMF vendor activities, providing study/program/CRO level reporting, and leading monthly TMF health checks
• Under guidance/supervision of the Clinical Operations Director, evaluates vendor activities to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff to achieve study milestones within agreed upon timelines, budget and quality
• Execute other oversight related activity as requested

Required Qualifications

• Minimum of 3 years relevant industry experience and at least 2 years of involvement with multi-disciplinary study teams. Alternatively, must have proven experience in all primary job functions
• 1-3+ years of clinical study experience with global clinical studies
• Experience in oversight of CROs, vendors and consultants
• 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

Desired Qualifications

• Clinical oversight or quality experience strongly preferred
• Desire to work in a fast-pace, dynamic environment
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
• Excellent communication and presentation skills
• Ability to read, write, and speak fluent English

Education

• Minimum of a bachelor’s degree in a life science or a health-related field
• Relevant professional certifications a plus

Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.