Centralized Study Asso I

2 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 & access management.
- Manage study documents such as study level, country level and site level.
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities
- Support study team in data review and 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 maintain project and technical documentation in an appropriate manner.
- To perform checks to ensure quality of work completed
- To ensure timely escalation as needed.
- 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 assist in Investigator Payment Processing
- 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

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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