Description
Our client, a leading pharmaceutical company is currently seeking a Clinical Scientist in Basel for a 6 month project with possible extension. This is a global pharmaceutical company with presence in varies countries around the world. They operate an open-minded environment, particularly within clinical study teams. This is a role with responsibility, where you will be empowered with the relevant decision-making authority, but will equally be accountable for your actions and responsibilities.Key Performance Indicators
- Timely delivery of quality documents to support the Clinical Development Plan (e.g. concept sheets, executable synopses); as well as clinical component of regulatory documents
- Effective risk management in design of trial synopses/protocols
- Efficient and timely execution of the trial protocol and related documents in collaboration with
- GTL, in compliance with international and local regulations and Novartis internal standards
- Demonstrates excellent scientific writing skills to enable the development of quality clinical protocols, trial reporting, and regulatory documents (no avoidable amendments)
- Submission of quality documents at Final Protocol Package (e.g. protocol, ICF, clinical sections of the CTA)
- Applies effective clinical research methodology, including trail design/analyses, efficacy endpoints, safety assessments across disease area and development phases
- Data cleaning & review process is successfully accomplished within the required time-lines across the trial with 100% clean data and no database unlocks area.
Languages: Fluent English (oral and written)
Experience:
- ? 4 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
- Manage several trials in parallel with multidisciplinary trial teams in a matrix organization
- Strong interpersonal skills
- Ability to work under pressure
- Excellent negotiation and conflict resolution skills
- Resolve issues with minimal supervision and understand when to escalate
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
- Demonstrates excellent scientific writing skills
- Knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.
- Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret/report data effectively
If you match the minimum requirements, please feel free to contact me directly.
Sebastian Spaniol
s.spaniol'@'realstaffing.com