Senior Documentation Coordinator

Location

Secunderabad | India

Job description

Job Title: Senior Document Coordinator (Global Trail Acceleration)

Location: Hyderabad (Hybrid, 2-3 days onsite in a week)

Required Experience: 4 to 8 years of relevant experience

Key skills: Clinical Operations, Site Initiation to close out(Identification, Initiation, Feasibility, Activiation), Global Trial, Study Startup, CTMS

Key Responsibilities:

• The Document Specialist is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation.
• The Document Specialist will interact with clinical study sites, Central 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 during start-up, maintenance and close-out of clinical studies.
• As the main point of contact for essential document management, develops and maintains collaborative working relationships with clinical investigative 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 global start-up documentation activities for 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), CTM, Study Team and BIA 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 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 (i.e., CTMS, eTMF, etc. or corresponding vendor systems)
• Arrange certified translation of study level documentation as requested (i.e., 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
• Act as single point of contact 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 external correspondence sent to investigative sites (i.e., IB updates, protocol amendments) and working with the sites to obtain IRB/IEC approval as needed.
• Ongoing support of Central IRB process, such as submissions and approval tracking in CTMS. May support centralized IRB/IEC submission of safety events [ i.e. 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/Clinical Trial Monitor (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.
• May be 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 BA or BS Degree in Legal, Life science, Business Administration or equivalent experience. Advanced degree a plus.
• Clinical development experience of 2 to 8 years of relevant industry experience (pharma, biotech, CRO or similar fields) required
• Knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma, Strong organizational, time-management, analytical and decision-making skills in order to efficiently evaluate, plan and accomplish work goals
• Computer skills - MS office suite, Sharepoint, etc. CTMS (Veeva 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.

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