Centralized Study Spec I

2+ years

Not Disclosed

Bangalore

10 Nov. 8, 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 is a global leader in clinical research, dedicated to scientific excellence and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a comprehensive range of clinical development, patient access, and technology solutions across over 20 therapeutic areas. With a presence in more than 90 countries and a workforce of 19,000+ professionals, Fortrea is revolutionizing the drug and device development process, benefiting partners and patients around the world.

Job Overview

Fortrea is seeking a Centralized Study Specialist I to join our dynamic team. This position will play a critical role in managing and supporting clinical study operations, ensuring timely execution, and maintaining high-quality standards. The ideal candidate will be responsible for overseeing key study functions, tracking milestones, and ensuring study teams are well-coordinated, compliant, and on track to meet study goals.

Summary of Responsibilities

Task Execution: Follow all applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs) to complete day-to-day tasks with a focus on quality, efficiency, and productivity.
Study Monitoring: Execute high-quality, timely monitoring and reporting plans, including specialized monitoring requests for approved protocols.
Metrics Tracking: Track and report study metrics based on management’s requirements. Proactively identify opportunities for process improvements and assist in implementing changes.
Mentorship: Provide guidance and train junior team members and support staff as needed.
Clinical Systems Management: Oversee clinical systems, including managing study documents, eTMF, and maintaining study databases (e.g., CTMS, IWRS, EDC).
Issue Management: Track and follow up with CRAs on any outstanding issues, ensuring prompt resolution.
Study Reports: Assist in generating study-specific reports and manage communications with internal and external stakeholders.
Compliance & Training: Support training compliance for study teams, ensuring all team members are up-to-date with required certifications and guidelines.
Study Payments: Assist with study payments, including site and vendor payments.
Documentation: Track and document study activities using relevant tools, including forms and Project Management Systems.
Cross-functional Collaboration: Actively collaborate with other support groups to facilitate study success, remove barriers, and ensure smooth operations.
Trial Master File (TMF) Management: Maintain TMF documentation, participate in TMF QC as assigned, and ensure that TMF documents are archived appropriately.
Leadership: Take a leadership role when needed, including overseeing teams with more than one Centralized Delivery Associate or Senior Centralized Delivery Associate. This includes task delegation and facilitating meetings.
Project Health: Support compliance metrics for TMF, CTMS, and overall project health. Ensure timelines and milestones are updated in relevant systems (e.g., MS Project, CTMS, and project governance tools).
Project Planning: Assist the Project Lead in drafting project plans, coordinating review and feedback, and executing tasks between study team members and the client.
Cross-functional Tasks: Provide support across additional project tasks, as required, to ensure study success.
Team Collaboration: Facilitate study team communications, set up team meetings, and ensure meeting notes are documented and distributed.
Vendor Management: Oversee vendor management as needed, ensuring vendors meet project milestones and deliverables.

Qualifications (Minimum Required)

Education: Bachelor’s Degree in Life Sciences, Business, or a related field.
Experience: Minimum 3-5 years of experience in a clinical research environment, with exposure to study management and monitoring.
Skills:
- Understanding of GCP, ICH guidelines, and clinical documentation requirements.
- Proficiency in managing clinical trial systems (e.g., CTMS, IWRS, EDC).
- Strong communication and organizational skills.
- Ability to track and report metrics accurately, maintaining high-quality standards.
- Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

Advanced Education: Master’s Degree in Life Sciences, Business, or a related field.
Clinical Systems: Experience with clinical electronic systems and familiarity with the Trial Master File (TMF).
Vendor Management: Experience with managing vendors in a clinical setting.
Leadership: Previous experience mentoring or leading teams within a clinical research environment.

Physical Demands / Work Environment

Travel: Minimal travel (less than 10%) required for Sponsor Kick-Off Meetings, Face-to-Face Client Meetings, or other study-related events.
Work Environment: The role may be performed remotely or in an office-based environment depending on project needs and location.

Why Join Fortrea?

At Fortrea, we're committed to transforming clinical research and delivering life-changing therapies to patients across the globe. If you're passionate about clinical trials, teamwork, and making a meaningful impact, we invite you to join our innovative and collaborative team. Embrace a dynamic workplace where your professional growth is supported and you contribute to groundbreaking research that makes a real difference.

To learn more about Fortrea and explore our career opportunities, visit www.fortrea.com.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace and do not tolerate discrimination or harassment of any kind. We make employment decisions based on individual qualifications and the needs of the business, and we encourage all qualified individuals to apply.