Centralized Study Spec Ii

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.
- Follow all applicable departmental Standard Operating Procedures and Work Instructions.
- Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
- Support implementation of new monitoring tools
- Track and report metrics as determined by management according to required timelines.
- Proactively identify opportunities for process improvements and participate in implementation.
- Able to mentor and train others.
- Other duties/activities as assigned by study management team, but not limited to:

- Manage clinical systems
- Manage study documents and support eTMF management
- Support study teams to resolve data management queries
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Track and follow up with CRAs for outstanding issues
- Support in generating the study specific reports.
- Manage internal/external communications
- Assist in ensuring training compliance for study teams
- Manage study payments (Site and Vendor) - Ex: Payment reconciliation and release
- Review study performance dashboard
- Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
- Actively support compliance metrics including TMF, CTMS, and overall project health.
- Update timelines and milestones within project scheduling tools, CTMS, project governance tool, and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk.
- Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations.
- Draft or assist Functional Leads with project plans and coordinating review, feedback, and execution between study team and client.
- May assist with additional cross-functional tasks according to project needs.

Additional responsibilities (Centralized study team may perform below activities)
- Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed.
- Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements
- Vendor Oversight Management

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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