Clinical Trial Documentation Specialist

2 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Description

This role is responsible for managing and executing centralized activities in support of global clinical trials, with a focus on clinical documentation. The successful candidate will interact with CROs, vendors, country trial managers, and other stakeholders to ensure compliance with regulatory standards and Bristol Myers Squibb policies.

Key Responsibilities
  • Manage and execute centralized activities in support of global clinical trials, with a focus on clinical documentation.
  • Interact with CROs, vendors, country trial managers, and other stakeholders to ensure compliance with regulatory standards and Bristol Myers Squibb policies.
  • Develop and maintain collaborative working relationships with relevant stakeholders.
  • Support outsourcing activities by interfacing with operational teams, support groups, and service providers.
  • Initiate and manage start-up documentation activities for global clinical trials.
  • Submission of potential investigators to CTSS for debarment review and tracking of decisions.
  • Responsible for country/Site Activation for clinical trials as applicable per region.
  • May provide a level of quality control of start-up activity.
  • Update and review of various study-related clinical systems.
  • May arrange certified translation of study level documentation from translators as requested.
  • May assist with the coordination or creation of other study specific materials.
  • May act as single point of contact for the study team for centralized activities during study start-up.
  • Ongoing maintenance and tracking of essential documentation and collection of updated/outstanding documentation and submission as required during all phases of clinical trial.
  • Ongoing communication with study teams regarding centralized study activities.
  • May be responsible for creation and management of standardized document templates.
  • Assist with generation of CSR appendices and CSR distribution as needed.
  • Country and site level ICF adaptation.
  • Essential document collection, review and approval of country and site level documents.
  • Centrally reviewing all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks.
Qualifications and Experience
  • Minimum of a bachelor's degree in legal, life science, business administration, or equivalent experience.
  • Minimum 3 years of relevant clinical development and operational experience in pharmaceutical, biotech, CRO, or similar fields.
  • Seasoned field monitor with min 3+ years of global site monitoring (Clinical Research Associate) report review experience is preferred.
  • Prior therapeutic area expertise (eg: Oncology, Cardiology, Hematology, Immunology etc) is preferred.
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.
  • Knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma.
  • Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
  • Effective communication skills in English (written & oral), computer skills - MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred, knowledge of portals, databases and other Clinical Trial enabling technologies).
  • Proven experience in managing key internal and external stakeholders effectively.
  • Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
  • Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
  • Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
  • Ability to sustain high levels of performance in a constantly changing environment.

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