As a Clinical Trial Support Specialist, you will be responsible for managing and reconciling Clinical Trial Submission documents in alignment with regulatory guidelines. This role emphasizes maintaining consistency across BMS programs, ensuring compliance, and supporting clinical trial operations.
Responsibilities
- Collaborate with the Submission Manager to streamline Clinical Trial document processes.
- Prepare submission documents adhering to regulatory standards, including CSR appendices and financial disclosure tables.
- Format documents to ensure Submission Ready Compliance (SRC).
- Manage creation and maintenance of site numbers for clinical trials.
- Enter site milestones and regulatory approval dates to maintain trial data quality.
- Ensure drug shipment addresses feed correctly into SAP for IP Supply.
- Reconcile data in Veeva systems (eTMF/CTMS) for accuracy.
- Provide critical thinking and resolution strategies to operational challenges.
- Apply knowledge of GCPs, ICH, and regulatory requirements to ensure compliance.
- Manage interactions with senior-level teams across the oncology portfolio.
- Perform additional tasks as assigned to support Clinical Trials.
Qualifications and Experience
- Education: Bachelor’s degree in a clinically related or relevant field.
- Experience:
- 2–4 years in clinical trial documentation management or related fields.
- Knowledge of ICH/GCP and regulatory guidelines.
- Experience with Clinical Trial Master File Systems (preferably Veeva Vault Clinical).
- Familiarity with MS Office, SharePoint, and other clinical trial technologies.
- Skills:
- Strong organizational, analytical, and decision-making abilities.
- Experience in managing cross-functional, multicultural teams in a matrix structure.
- Adaptability to a dynamic and evolving work environment.
- Proficient communication and document management skills.
Key Competencies
- Proactive problem-solving and critical thinking.
- Strong understanding of clinical, ethical, and regulatory components in drug development.
- Ability to manage complex issues and multitask effectively.
- Exceptional written and oral communication skills.
