Clinical Protocol Lead
Clinical Protocol Lead
Clinical Protocol Lead (CPL) 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.
- Direct the execution of clinical trial activities in accordance with Cerevel SOPs, ICH Guidelines, and Good Clinical Practice (GCP).
- Ensure compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection.
- Represent Clinical Operations on the cross-functional clinical study team and interact with internal and external groups to achieve study milestones.
- Determine study requirements, define specifications, and contribute to the selection of third-party vendors
- Manage CRO relationship 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.
- Communicate clinical studies performance data to other members of the management and scientific team.
- Oversee the preparation and maintenance of required study and regulatory documentation, e.g., reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts and budgets
- Contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
- Execute other protocol or program related activity as requested.
- Minimum of 5 years relevant industry clinical management experience and at least 3 years of involvement with multi-disciplinary study teams. Alternatively, must have proven experience in all primary job functions.
- 1-3+ years of clinical study management 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.
- Experience developing/reviewing trial plans including site monitoring, risk mitigation strategies, site selection and drug accountability.
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Clinical Coordinator and/or Clinical Research Associate 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
- Team player
- Ability to read, write, and speak fluent English
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; produces high-quality deliverables
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web-based communication tools for conferences
- Working knowledge of medical terminology and experience with clinical research
Minimum of a bachelor’s degree in a life science or a health-related field is 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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