The Senior Clinical Research Scientist/Associate Director will participate in global Oncology Research Studies. The primary responsibility will be to support protocol development and all amendments, study conduct, review study documents, and support the presentation of the data thereby, increasing the efficacy of the study directors and team leaders.
Responsibilities include but are not limited to:
CDP Development and Management
• Supports the planning, execution and reporting of clinical programs/ trials
Clinical Research Protocols
• Reviews and Revises Clinical Protocols as follows:
- Develops Protocol Concept Sheets (PCS1 and PCS2) for review by CRAB
- Develops/reviews Clinical Protocols
- Manages medical writer(s) and coordinates writing activities across internal/external stakeholders
Clinical Study Reports
• Contributes to CSR development (reviews/interprets clinical data provided in Tables, Listings, Graphs)
• Manages medical writer(s) and coordinates CSR activities across internal/external stakeholders
• Reviews study documents (i.e., investigator databases, ICFs, IEC/ IRBs submissions)
Clinical Research Expert
• Contributes to risk resolution by escalating and monitoring projects risks
• Makes recommendations for improving resources (tools, systems, vendors, etc.) needed by the team
• Manages the workflow of others to ensure work is done within a given deadline
• May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines
• Tracks the expenses of work teams to anticipate cost issues
• Manages the use of financial standards, guidelines and compliance for more informed and empowered decisions
• May assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate
Matrix and Team Management
• Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis
• May support employees by providing input into recruitment, selection, performance, succession, and transition activities
• Trains team members on processes and / or systems
• Collaborates with various stakeholders: internal (various functions including Statistics, Data Management, Clinical Operations, etc.) and external (e.g. Pharma partners, investigators, CROs, other vendors, etc.)
This position requires a minimum of an advanced degree in a scientific discipline (i.e. M.D. or Ph.D).
• Sr. Clinical Research Scientist: 2-5 years of experience in a related clinical research position within the pharmaceutical industry; Associate Director: 5-7 years of related clinical research experience within industry. Significant knowledge of clinical research methods and processes is required and the application to cancer drug development is highly preferred
• Good oral and written communication skills are essential. Good presentation skills (including report development) are a plus but not a requirement.
• Good attention to detail
• Successful work experience in a matrix team environment with cross functional teams is required.