Centralised Study Asso Ii

7 days 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. 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 & access management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities
- Support study team in data review and support activities.
- Support in generating the study specific reports.
- Generate Study Reports
- Perform Access management on applicable study systems
- Perform study system set up on new awarded studies
- CTMS compliance management
- Manage project communications
- Assist project teams for other study support activities
- 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 track and report metrics as determined by management according to required timelines.
- To assist with the implementation of revised processes and procedures.
- 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 the study, startup teams with tasks required for site start up activities.
- To manage and support assigned studies for upload as per set objectives
- To follow up with study team on uploading queries
- To review, Support, Manage or assist in Managing the study clinical trial contacts in accordance with defined processes and timelines.
- And all other duties as needed or assigned

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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