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    Centralized Study Spec I

    Fortrea
    5+ 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) dedicated to scientific excellence and with decades of clinical development experience, Fortrea delivers a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Our team of over 19,000 professionals operates in over 90 countries, driving innovation in drug and device development to benefit partners and patients worldwide.

    Key Responsibilities:

    • Adhere to all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
    • Execute daily tasks to ensure high quality and productivity.
    • Implement and monitor high-quality, timely reporting plans, including specialized monitoring requests for approved protocols.
    • Track and report metrics as defined by management, meeting deadlines and proactively identifying opportunities for process improvement.
    • Mentor and train team members.
    • Additional duties may include:
      • Managing clinical systems and study documents, supporting eTMF management.
      • Maintaining study databases (CTMS, IWRS, EDC, etc.).
      • Tracking and resolving issues with Clinical Research Associates (CRAs).
      • Supporting the generation of study-specific reports.
      • Overseeing internal and external communications.
      • Assisting with training compliance for study teams.
      • Supporting study payments (site and vendor).
    • Document and track study activities using relevant forms, tools, and Project Management Systems, including Clinical, SU, and VM data.
    • Lead efforts to ensure successful partnerships with other support groups and help remove barriers to facilitate project success.
    • Maintain Trial Master File (TMF) documentation within the TMF platform, participate in TMF quality checks, and manage documentation tracking and archiving.
    • Serve as the Centralized Study Specialist I on projects involving multiple Centralized Delivery Associates or Senior Centralized Delivery Associates, providing guidance, facilitating teleconferences, and overseeing task reviews and delegation.
    • Actively support compliance metrics, including TMF, CTMS, and overall project health.
    • Update timelines and milestones in MS Project, CTMS, project governance tools, and other trackers, escalating risks as necessary.
    • Draft or assist Project Leads with project plans and coordinate review, feedback, and execution between the study team (functional leads) and clients.
    • Perform additional cross-functional tasks as needed.

    Additional Responsibilities (Centralized Study Team):

    • Facilitate study team communication and collaboration by organizing and attending meetings for all functions as needed.
    • Document and distribute meeting notes and ensure they meet study requirements.
    • Oversee vendor management.

    Fortrea is seeking motivated problem-solvers and innovative thinkers who are passionate about overcoming challenges in clinical trials. We are committed to transforming the development process and delivering life-changing therapies to patients swiftly. 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:

    As an EOE/AA employer, Fortrea is dedicated to fostering a diverse and inclusive workforce and does 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 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. We encourage all qualified individuals to apply.

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