Centralized Study Spec Ii

2+ years

Not Disclosed

Bangalore

10 Sept. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Fortrea

Fortrea, a leading global Contract Research Organization (CRO), is dedicated to scientific excellence and boasts extensive experience in clinical development. We offer a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a team of over 19,000 professionals operating in over 90 countries, Fortrea is at the forefront of transforming drug and device development worldwide.

Position Overview

We are looking for a motivated and detail-oriented professional to join our team, where you will play a key role in supporting and executing high-quality clinical studies. You will ensure timely and accurate monitoring and reporting, support the implementation of new monitoring tools, and contribute to process improvements.

Key Responsibilities

Adhere to departmental Standard Operating Procedures (SOPs) and Work Instructions.
Develop and execute high-quality monitoring and reporting plans, including specialized monitoring requests for approved protocols.
Support the implementation of new monitoring tools and track/report metrics as determined by management.
Proactively identify opportunities for process improvements and participate in their implementation.
Mentor and train team members as needed.
Manage clinical systems and study documents, including eTMF management.
Support study teams by resolving data management queries and maintaining study databases (CTMS, IWRS, EDC, etc.).
Track and follow up with Clinical Research Associates (CRAs) on outstanding issues and generate study-specific reports.
Oversee internal and external communications and ensure training compliance for study teams.
Manage study payments (site and vendor), including payment reconciliation and release.
Review study performance dashboards and document study activities using relevant tools and Project Management Systems.
Maintain Trial Master File (TMF) documentation and support TMF Quality Control (QC) and archival processes.
Update timelines and milestones in project scheduling tools and escalate risks as necessary.
Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and resolve outstanding action items, including protocol deviations.
Draft or assist Functional Leads with project plans and coordinate review, feedback, and execution between the study team and client.
Facilitate study team communication and collaboration by organizing meetings and documenting discussions.
Oversee vendor management and ensure effective collaboration with all functions.

Why Join Us?

At Fortrea, we are committed to overcoming barriers in clinical trials and revolutionizing the development process to deliver life-changing therapies to patients. Join our dynamic team and experience a collaborative environment where personal growth is fostered, enabling you to make a significant global impact.

Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We value diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, and we welcome applications from all individuals regardless of race, religion, color, national origin, gender (including pregnancy and medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

For more information on how we handle your personal data, please refer to our Privacy Statement.

Learn More

To learn more about Fortrea and our innovative work in clinical trials, visit www.fortrea.com.

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