Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Requirements
- Provides clinical input/review to clinical development program plans
- Provides clinical input/review to clinical documents and ensures the integrity of clinical data prior to submission to regulatory authorities
- Manages clinical timelines, budgets, and resources against the approved CDP in collaboration with PMO
- Provides oversight to third party vendors and trains them on SOPs, as necessary
- Manages vendor performance, including on time study completion, budget adherence, and quality deliverables
- Collaborates with Biometry to ensure timely data transfers for data cleaning, review and analysis
- Collaborates with Clinical Supplies to ensure timely manufacturing, packaging, labeling, shipping of clinical trial supplies
- Manages responses to audits, as necessary
- Develops program/study status presentation materials during internal management and advisory meetings
- Maintain awareness of SAEs that are reported
- Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies)
- Escalates significant issues on program(s) and study(ies) to senior management in a timely manner
- Attends cross functional project team meetings
- Maintains good knowledge of the literature for the indication being studied and reviews and summarizes relevant literature for the therapeutic area of interest, as necessary
- Assesses feasibility and best strategic path forward for a clinical program and endpoints
- Drives clinical strategy recommendations including timelines and cost to key stakeholders
- Participates and contributes to internal and external training for clinical program
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
