- Write and implement project-specific study plans in alignment with the executed contracts and/or work orders.
- Review and approve data and records associated with assigned studies including validation, post validation, stock stabilities, clinical and non-clinical studies.
- Conduct and ensure studies are in accordance with applicable SOPs, GLPs, and protocols
- Collaborates with QC team and document coordination team in finalizing the study reports.
- Ensure data, reports, and any supporting documentation is delivered to the Sponsor by the agreed upon date
- Ensure timely and accurate responses to project managers, project leaders, department leaders and sponsors.
- Strong Scientific background.
- Effective time management skills
- Analytical problem-solving skills
- Ability to direct and train others in laboratory skills and project specific tasks related to their assigned studies
- Ability to review proposals, analytical test methods, protocols, reports, and SOPs.
- Ability to successfully prioritize study needs and effectively manage competing timelines
- Excellent communication skills – internally and externally; verbal and written
- 8+ of relevant work experience in a Bioanalytical Laboratory
- Bachelor's degree (Masters preferred) in Chemistry, Biochemistry, Pharmacology, Immunology, Pharmaceutical science or
- High School Degree and 12 + years of experience in Bioanalytical Laboratory
- Minimum of 5 years' experience in a regulated (GxP) environment.
- Experience in Pharmaceutical, Biotechnology or Contract Research Organizations
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Senior Scientist, Bioanalytical Study Manager AUSTIN- IN OFFICE - Austin, United States - Worldwide Clinical Trials
Description
Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us
What the Senior Scientist, Bioanalytical Study Management
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
What you will bring to the role
Your experience
Why Worldwide
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at For more information on Worldwide, visit or connect with us on LinkedIn.
