Senior Clinical Research Scientist
Há 4 dias
At ENGINEERINGUK, we are seeking a highly skilled Senior Clinical Scientist to join our team. As a Senior Clinical Scientist, you will play a key role in providing scientific, clinical, and operational input to early and late-stage clinical development programs.
Key Responsibilities:- Conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
- Conduct medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
- Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead.
- Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety.
- Develop protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead.
- Collaborate with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; respond to or triage questions for appropriate escalations.
- Represent the client to outside personnel in the development of clinical protocols and study conduct.
- Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
- Lead literature reviews as needed.
- Prepare scientific material for conference presentations or publications.
- In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy); proficient knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Ability to make independent, timely and appropriate decisions.
- Strong oral and written communication skills to explain difficult information and solid computer/analytical skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- High level of organizational and project management skills.
- Flexibility to accommodate changes in team and project needs.
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
At ENGINEERINGUK, we offer a comprehensive and competitive total reward package that comprises an excellent level of base pay, variable pay, and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career.
We are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.
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