The position will participate in global Neurology Research Studies. Primary responsibility will be to support protocol development, protocol amendments, study conduct and oversight, study document preparation and review, and data preparation, use, and presentation
1. CDP Development and Management
- Supports the planning, execution and reporting of clinical programs/ trials
2. Clinical Research Protocols
- 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
3. 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
4. Collaboration with various stakeholders
- Internal (various functions including Statistics, Data Management, Clinical Operations, etc.) and external (e.g. Pharma partners, investigators, CROs, other vendors, etc.)
5. Study Management
- Reviews study documents (i.e., investigator databases, ICFs, IEC/ IRBs submissions)
6. Clinical Research Expert
- Contributes to risk resolution by escalating and monitoring projects risks
7. Resource Management 5%
- 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.
8. Financial Management
- 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.
- Complies with all applicable laws / regulations of each country in which we do business.
- Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians.
- Reports legal, compliance and ethical violations in a timely manner.
- Degree in Life Sciences (MD, PhD or PharmD )
- 5+ years of pharmaceutical/biotech clinical research experience
- Prior Management experience is a plus
- Comprehensive knowledge of Neurology drug development process
- Proficient knowledge of GCP/ICH, study design, statistics, clinical operations
- Excellent verbal, written, communication and interpersonal skills. Must be able to effectively communicate and collaborate across functions and job levels.
- Strong sense of teamwork; ability to lead team activities
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Proficient in Medical Terminology and medical writing skills
- Proficient critical thinking, problem solving, decision making skills
- Understanding of functional and cross-functional relationships
- Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture, or similar data reporting tools