Clinical Business Administrator
hace 3 semanas
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Job Overview:Summary of Responsibilities:- Create and update study details in Veeva UCV.- Update study details in Siebel CTMS.- Update trip report templates in Veeva UCV.- Maintain CBA job aids.- Utilize strong Excel and editing skills for template management.- Assist in resolving conflicts and support technology platforms.- Monitor project schedules and scope to ensure both remain on track.- Engage in quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and internal/external client requirements.- Ensure all systems, processes, and their outcomes comply with standards that meet applicable regulations and guidelines, and Fortrea requirements.- Research techniques to drive optimal performance effectiveness.- Prepare and deliver presentations in collaboration with relevant departments as required (internal and external).-- Complete non-problem service requests in accordance with established team processes.- Develop and maintain technical and user documentation.-- Lead and support other support analysts on complex scope problems.- Interact with the Application support team to assist in problem resolution.Qualifications (Minimum Required):- Minimum of three (3) years experience in a health care or clinical research setting.- Working knowledge of ICH Guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs.- Broad knowledge of the drug development process and internal/external client needs.- Veeva Admin certification.- Experienced (at least 2+ years) Oracle Siebel Developer.- Proficiency in Oracle Siebel Tools and ability to debug and troubleshoot.- Knowledge to perform standard administrative functions.- Knowledge of loading data to CTMS from Microsoft Excel or flat files.- Knowledge of OBIEE and CDA is a plus- Experience in Oracle Database (10g, 11g) and SQL queries.Experience (Minimum Required):- University/college degree - life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical, or laboratory technology).- Strong understanding of clinical trials and trial operations, including study setup and the role of a monitor completing trip reports.- Excellent leadership skills.- Excellent oral, written, and presentation skills.- Excellent planning and organizational skills, including the skills necessary for implementing corporate change.- Demonstrated ability to lead by example and encourage team members to seek solutions.- Administration experience with Veeva UCM and Siebel CTMS.- Demonstrated ability to handle multiple competing priorities.Preferred Qualifications Include:- Advanced Degree (e.g., MBA)- Experience in fast-paced environments- Creative and strategic thinking- Exceptional analytical skills- Excellent communication and interpersonal skills- Strong leadership qualitiesLI-REMOTELI-GS1Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see ourPrivacy Statement.
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