Submission Specialist - CT

Location

Secunderabad | India

Job description

The Submission Specialist manages and coordinates the signing of CTA documentation for all clinical trials/participates in the timely, compliant, and accurate delivery of the core submission documents and dossiers to BMS HA/EC Applicants or CRO. The Submission Specialist also participates in the preparation of the CTIS for CT under the EU Regulation.

Position Responsibilities

• Manage the signing of clinical trial documentation such as powers of attorney, expected to be able to coordinate many signing at the same time.
• Provide support to the Submission Senior Specialist/Manager in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
• Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs.
• Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
• Ensure consistency of the Clinical Trial application across projects, studies and countries.
• Actively participate in Program/Study level CTA Tracking Meetings, led by Senior Specialist/manager role, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
• Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
• Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates.
• Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
• Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements.
• Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT.
• Expected to be able to coordinate updates within a Program.
• Support continuous improvement and compliance initiatives
• Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates
• Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.
• Support implementation of the EU CT REG Portal from Feb 2022

Degree Requirements

BA/BS degree, science / technology field preferred

Experience Requirements

1-2 years pharmaceutical experience

Key Competency Requirements

• Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
• Communicates questions and issues as they arise with possible solution.
• Supports other functions as appropriate.
• Participates in study team meetings.
• Works with supervision.

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Job tags

Salary