Clinical Scientist

Harvey Nash is looking for a Clinical Scientist for a 6 month project in Switzerland.
- The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with internal processes, GCP/ICH and regulatory requirements
- You are responsible for
- developing In collaboration with Trial Statistician Reporting and Analysis Planning (RAP) modules in line with program standards
- to drive development and implementation of relevant data capture tools in collaboration with GTL and IIS as documented in data handling plan or equivalent document (eg CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
- managing all trial related committees (eg., Data Monitoring, Adjudication) including decision making around key parameters to monitor and report; preparation of charters and data for review; manage committee meetings/reviews timelines; and provide regular updates to Safety Management Team and other clinical boards
- the ongoing review of clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and perform data reconciliation
- Collaborating with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (eg SMT, GCT, GPT).

Requirements

- Advanced degree (or clinically relevant degree) in life sciences/healthcare is required
- PharmD, PhD preferable
- = 4 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
- 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
- Fluent English (oral and written)

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV (Word documents preferred) to me.

For further details feel free to call me. I am looking forward to receiving your application.