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Document Coordinator, Global Trial Acceleration

3+ years
Not Disclosed
10 Dec. 20, 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

Job Title: Document Coordinator - Clinical Trials
Location: [Insert Location]
Category: Clinical Research
Job ID: [Insert Job ID]

Position Summary:
As a Document Coordinator at Bristol Myers Squibb, you will play a vital role in managing clinical trial-related documents across all phases of global clinical trials. This includes the collection, compilation, review, and approval of essential documents, as well as addressing site monitoring reports, issue escalation, and follow-up. You will serve as the main point of contact for clinical documentation, regulatory submissions, and support for the study team throughout the trial lifecycle.

Key Responsibilities:

  • Manage and execute centralized activities for global trials with a focus on clinical documentation.
  • Interact with CROs/vendors, Country Trial Managers (CTMs), Clinical Trial Monitors (CTMos), and other stakeholders to support study progress from start-up to close-out.
  • Support the submission and review of regulatory documents, ensuring compliance with ethical and regulatory standards.
  • Facilitate outsourcing activities, ensuring compliance with BMS policies and regulatory requirements.
  • Initiate and manage start-up documentation activities, including country/site activation for trials.
  • Track, review, and collect essential trial documentation, updating clinical systems (e.g., CTMS, eTMF).
  • Assist in the creation and management of standardized document templates and other study-specific materials.
  • Review Site Monitoring Visit reports, escalate issues, and track resolutions.
  • Provide quality control over start-up activities and assist with clinical study report (CSR) generation.
  • Act as the single point of contact for the study team during start-up and ensure timely communication regarding centralized study activities.

Qualifications & Experience:

  • Bachelor’s degree in Legal, Life Sciences, Business Administration, or related field (advanced degree preferred).
  • Minimum of 3 years of clinical development and operational experience in the pharmaceutical, biotech, or CRO field.
  • Previous experience as a clinical research associate (CRA) with at least 3 years of global site monitoring report review experience preferred.
  • Hands-on experience with regulatory submissions to IRBs/IECs and regulatory agencies.
  • Familiarity with ICH/GCP guidelines and drug development processes.
  • Strong organizational, time-management, analytical, and decision-making skills.
  • Excellent written and oral communication skills in English; proficiency with MS Office, SharePoint, CTMS (Veeva Vault preferred).
  • Proven ability to manage cross-functional, multi-cultural teams and effectively engage stakeholders.
  • Flexibility and adaptability to work in a dynamic environment and manage multiple priorities.

Company Overview:
At Bristol Myers Squibb, we are united by a vision of transforming patients' lives through science. Our work goes beyond the ordinary, empowering employees to bring their unique talents and perspectives to an inclusive culture, where diversity in clinical trials is celebrated. Our core values of passion, innovation, urgency, accountability, inclusion, and integrity drive us to achieve our highest potential.

On-site Protocol:
BMS has a diverse occupancy structure. Depending on your role, you may be required to work onsite, in a hybrid model, or remotely. The nature of the role will dictate your work location type.

Equal Opportunity Statement:
Bristol Myers Squibb is committed to creating an inclusive environment and ensuring equal employment opportunities for all individuals. We encourage applicants from all backgrounds and offer accommodations to those who need them during the recruitment process.

How to Apply:
Learn more and apply through the Bristol Myers Squibb careers portal: BMS Careers.