What are the responsibilities and job description for the Senior Scientist, Bioanalytical Study Manager IN OFFICE AUSTIN, TX position at Worldwide Clinical Trials - USA?
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
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 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
What you will bring to the role
Your experience
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 Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
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 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
- 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.
Your experience
- 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
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 Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
