Senior Centralized Study Asso

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

As a premier global contract research organization (CRO) with a strong emphasis on scientific excellence and extensive clinical development experience, Fortrea offers a comprehensive suite of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a dedicated team of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of advancing drug and device development for partners and patients worldwide.

Key Responsibilities:

Adhere to all departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Execute daily tasks to ensure high quality and productivity.
Track and report metrics as defined by management, meeting required deadlines.
Engage in process improvement initiatives and assist with the implementation of revised processes and procedures.
Additional duties may include:
- Managing clinical systems and access.
- Overseeing study documents and supporting eTMF management.
- Maintaining study databases (CTMS, IWRS, EDC, etc.).
- Assisting the study team with data review and support activities.
- Tracking and addressing issues with Clinical Research Associates (CRAs).
- Generating study-specific reports.
- Managing internal and external communications.
- Ensuring training compliance for study teams.
- Handling study payments (site and vendor).
- Documenting and tracking study activities using relevant forms, tools, and project management systems.
- Maintaining Trial Master File (TMF) documentation within the TMF platform, participating in TMF quality checks, and managing documentation tracking and archiving.
- Supporting compliance metrics, including TMF, CTMS, and overall project health.
- Updating project timelines and milestones in scheduling tools, CTMS, and other trackers, and escalating risks as needed.
- Updating the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and ensuring resolution of outstanding action items, including protocol deviations.
- Drafting or assisting Functional Leads with project plans and coordinating review, feedback, and execution between the study team and clients.
- Working with the Study Team to maintain WISER moments.
- Potentially assisting with additional cross-functional tasks based on project needs.

Additional Responsibilities (for Centralized Study Team):

Facilitate study team communication and collaboration by organizing and attending team meetings for all functions as required.
Document meetings with relevant tools and ensure distribution in accordance with study requirements.
Oversee vendor management.

Fortrea seeks motivated problem-solvers and innovative thinkers who are passionate about overcoming challenges in clinical trials. Our goal is to revolutionize the development process, accelerating the delivery of transformative therapies to patients in need. Join our dynamic team and experience a collaborative environment that fosters personal growth and makes a global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer. We are committed to diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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. We encourage all qualified individuals to apply.

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Senior Centralized Study Asso

Job Description

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