Document Coordinator, Global Trial Acceleration

Location

Secunderabad | India

Job description

• The Document Coordinator is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation.
• The Document Coordinator will interact with clinical study sites, Central/Local IRB/IECs, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo.), the study team and other functional areas within BMS and will provide support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies).
• As the main point of contact for essential document management, ethical and regulatory submission-related activities, develops and maintains collaborative working relationships with clinical investigator sites.
• Support outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures.
• Initiate and manage start-up documentation activities for global clinical trials:
• Generation, processing, tracking and distribution of Confidential Disclosure Agreements (CDAs).
• Provide input into the creation of the feasibility questionnaire; distribution and tracking of the questionnaires; provide coordinated feedback to Global Trial Manager (GTM)/Global Trial Specialist (GTS), Clinical Trial Manager (CTM), Study Team and Business Insights & Analytics (BI&A) as applicable.
• Submission of potential investigators to CTSS for debarment review and tracking of decisions.
• Review of essential regulatory documentation and interaction with sites to resolve outstanding issues, including submission of final documents to the electronic Trial Master File (eTMF)
• Responsible for Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the site activation checklist, and submission to Regulatory.
• The incumbent may also be responsible for activating the site in accordance with all applicable global / local study procedures.
• May provide a level of quality control of start-up activity.
• Update and review of various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (ie, CTMS, eTMF, etc or corresponding vendor systems)
• Arrange certified translation of study level documentation from translators as requested (ie, ICF, Protocol, IB)
• May assist with the coordination or creation of other study specific materials such as pharmacy or Investigator site file to ensure that these are available on site for site initiation visits/prior to first patient visit.
• 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 to Regulatory as required.
• Managing all correspondence sent to investigative sites (ie, IB updates, protocol amendments) and working with the sites to obtain IRB/IEC approval as needed, in collaboration with the country CTM/ CTMo.
• Ongoing support of Central/Local IRB/IEC process, such as submissions and approval tracking in CTMS. May support centralized IRB/IEC submission of safety events [ ie, SUSARS, six-monthly line listings and Development Safety Update Report (DSUR)].
• Ongoing submission of documents to the eTMF and review/Quality Control (QC) of the eTMF to ensure accuracy and completeness including working with sites, CTM/CTMo., and study team to resolve issues related to missing or expired documents.
• Ongoing communication with sites and study teams regarding centralized study activities.
• Lead or ensure that that the global process for the ongoing collection and review of Financial Disclosure Forms is followed as specified.
• Maybe responsible for creation and management of standardized document templates.
• Assist with generation of CSR appendices as needed.
• Other duties as assigned to support Clinical Trials.

Qualifications & Experience

• Minimum of a bachelors degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus.

• 3-5 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries.
• Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries.
• 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 by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
• 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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Salary