Clinical Operations Manager – Late Phase
Clinical Operations Manager – Late Phase
Full-time Boston-based position responsible for the execution and oversight of Phase 1 clinical research protocols and IND development for Cerevel products, with a focus on the CNS therapeutic area. The incumbent will also have line management responsibilities.
- Manages the overall early-phase clinical operations, inclusive of planning, execution and reporting, program(s)/protocols, reporting to the Head of Scientific Operations, Clinical Operations
- Assist in defining and developing the clinical operations strategy and study protocols
- Manage External Service Providers, including CROs, in order to ensure the successful conduct of Cerevel Clinical Trials in accordance with applicable SOPs, ICH GCP guidelines and State and Federal regulation
- Report key trial performance information, including established KPIs, enrollment and performance related metrics
- Review and/or approve clinical trial documents for assigned program/protocols (ICFs, Clinical Trial Plans, Case Report Forms, Data Management Plans etc.)
- Responsible for managing assigned aspects of the budget, timelines and risk mitigation processes with input from collaborating departments
- Serve as Key Stakeholder for applicable standard operating procedures
- Ensure that a full protocol/program specific training plan is in place for Sponsor, CROs, ESPs and Clinical Sites, and that the proper documentation of said training is created and filed.
- Drive risk mitigation for assigned project(s)
- Clinical Ops lead for data analysis and reporting
- Direct line-management responsibility for assigned Clinical Trial Leads/Clinical Oversight Lead.
- Provides final list of principal investigators, in collaboration with the CRO, for Project Lead approval
- Approves CVs for ESP monitoring staff
- Oversees the CRO relationship and provides input into the governance committee
- Involved in product life cycle management
- Will help support regulatory filing activities
- Lead and/or participate in departmental initiatives as assigned
- Performs other duties as assigned
- Prior late-phase (Phases 2-3) clinical trial management experience – 3 years (Manager); 5 years (Sr. Manager)
- CNS experience strongly preferred; Parkinson’s Disease and/or Epilepsy experience a plus
- An advanced understanding of drug development principles and clinical trial implementation and management, inclusive of strong project management skills
- Working knowledge of ICH GCP and global regulatory requirements
- Understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting. Ability to work with different therapeutic areas and different stages of clinical development.
- Demonstrated experience in successful regulatory filings is a plus
- Demonstrated ability to manage and motivate all clinical team members (e.g., internal staff and external investigators/consultants).
- Strong computer skills with demonstrated experience working in the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Strong computer skills with Word, Excel, PowerPoint, and Outlook
- Knows how/when to apply organizational policy or procedures to a variety of situations
- Desire to work in a fast-pace, dynamic environment
- Excellent communication and presentation skills
- Team player; experienced at developing talent
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
Bachelor of Science in a life science major required; Master’s and/ or Ph.D. preferred
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.
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