Centralized Study Spec I

3 months ago

Bengaluru Karnataka, India Fortrea Full time

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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

To complete other duties/activities as assigned by study management team, but not limited to: - Manage clinical systems. - Manage study documents and support eTMF management. - Maintain study databases (CTMS, IWRS, EDC etc.) Ø Track and follow up with CRAs for outstanding issues Ø Support in generating the study specific reports. - Manage internal/external communications. - Assist in ensuring training compliance for study teams. - Assist in study payments (Site and Vendor) - Data Review: o Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks. o Perform Associate Lead/Lead role for assigned projects. o Draft and send study specific reports as per the study team instructions. o Collaborate with DM, Programming team for reports and communication of data related tasks. o Perform any other data review related tasks as per the project team instructions. - Study Support: o Generate Study Reports and perform analysis. o Perform Access management on applicable study systems. o Perform study system set up on new awarded studies. o CTMS compliance management o Manage project communications. o Assist project teams for other study support activities. - Investigator Payments: o Review EDC, Contract, and mark line items “Ready to Pay/Screen Failure” in CTMS o Work with PA to generate cover letter or Proforma invoice and payment batch generation in CTMS. o Perform Invoice QC and Prepare GIA as applicable. o Coordinate with CTL, PM for line-item approvals and GIA approvals o Process Out of Pocket and Pass-Through Expense Invoices o Perform payment reconciliation during the study close out or on ad hoc request by the study team. o Act as a mentor and provide training to new joiners in team. o Performing quality check of the work delivered by the team as a part of the QC process. - To follow all applicable departmental Standard Operating Procedures and Work Instructions. - To complete required trainings according to required timelines. - To complete day-to-day tasks ensuring quality and productivity. - To manage project and technical documentation in an appropriate manner. - To provide administrative and technical support to internal departments and teams as needed. - To perform checks to ensure quality of work completed. - To ensure timely escalation and issue resolution as needed. - To execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols. - To support implementation of new monitoring tools. - To track and report metrics as determined by management according to required timelines. - To proactively identify opportunities for process improvements and support the implementation of process improvement activities. - To support the implementation of tools internally to enhance deliverables. - Ability to mentor and train others. - To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration. - To assist in the preparation of new investigator submission packages for site/regulatory submission. - To support study team for contracts and budgets activities for investigative sites - To assist the study start-up teams with tasks required for site start up activities. - To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.

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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