What are the responsibilities and job description for the Senior Scientist, Bioanalytical Study Manager IN OFFICE AUSTIN, TX position at Worldwide Clinical Trials?
What the Senior Scientist, Bioanalytical Study Manager does at Worldwide
The Senior Scientist, Bioanalytical Study leader is a role that involves overseeing the - conduct of regulated and non-regulated Bioanalytical studies. This individual collaborates with the cross-functional teams (sample management, bioanalytical labs, project management, document coordinators and quality assurance unit) for successful execution of Bioanalytical projects at Worldwide and ensures adherence to regulatory requirements. In this role they are responsible for development of project specific study plans and in ensuring projects are conducted in compliance with applicable (GLP, GCP and GCLP) regulatory guidelines. Senior Scientists provide leadership and collaborate with other functional teams in execution of projects and ensuring they oversee. They think and act strategically to align internal and externa resources to align with business needs and to meet customer’s expectations. A Senior Scientist regularly participates in the production of Scientific literature such as posters, presentations, and publications.
What you will do
- Write and implement project-specific study plans in alignment with the executed contracts and / or work orders.
- Assist with the review of lab manuals to ensure samples are collected in accordance with the scope of the validated method.
- Assist sample management in resolving sample discrepancies during shipping.
- Review and approve data and records associated with assigned studies including validation, post validation, stock stabilities, clinical and non-clinical studies.
- Ensure data, reports, and any supporting documentation is delivered to the Sponsor by the agreed upon date
- Lead / Assist with sponsor visits as needed
What you will bring to the role
Your experience
