Centralized Study Specialist Ii

hace 2 semanas

Ciudad de México CDMX Fortrea A tiempo completo

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.

Perform various FSA activities related to POs and receipts within Global Vendor Management. Maintain tracking systems and lessons learned database. Act as liaison between study teams and Genpact for resolution of procurement and invoicing issues, also ensure appropriate approves for vendor payments against purchase orders, resolving issues as appropriate. Assist with training and mentoring junior staff performing vendor management analyst activities. Develop, maintain, and improve internal and vendor procedures for requisitioning, invoice management and reconciliation
- Review Investigator Packages- Review amended Core ICFs
- Review Country/Site ICFs
- Develop Country initial ICFs
- Develop/Review Patient Recruiting materials (Advertisements)
- Develop/Review study plans/guidance
- Review initial/amended protocol
- Develop/Review Confidentiality Disclosure Agreement
- Provide input/responses to audit/CAPA findings related to tasks
- Manage study documents
- Manage applicable systems tracking and support eTMF management
- Track and follow up with relevant study team members for outstanding issues
- Manage internal/external communications
- To assist the study start up teams with tasks required for site start up activities
- To assist the study start up project management teams with tasks related to pre-award activities
- Perform any other duties as required by the department
- Mentor junior team members
- Subject Matter Expert for department specific processes and procedures

Minimum of two (2) years of experience utilizing Oracle Financials - Aptitude for handling and reviewing numerical data. - Abilities to set priorities and handle multiple tasks simultaneously. - Good oral and written communication skills - Computer literacy (word processing and spreadsheet software) - Good spelling and proofreading skills - Demonstrated aptitude for mentoring others. - Ability to operate standard office equipment. - Works efficiently and effectively in a matrix environment - Creative problem solver - Well organized - Team Player - Fluent in English, both written and verbal

Fortrea 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.

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