Clinical Trial Support Specialist
Core
Support clinical trial submissions and document management for oncology programs, ensuring regulatory compliance and data accuracy across the drug development lifecycle.
Role type
Mid-level clinical trial operations specialist (submissions & data integrity)
Builds
Regulatory submission packages (CSR appendices, financial disclosures) and accurate clinical trial data records
Domain
Pharmaceutical industry, oncology, clinical drug development
Required skills
Clinical trial document preparation, regulatory guideline adherence (ICH/GCP), data reconciliation, project management, document management systems, pharmaceutical industry knowledge, cross-functional team collaboration, risk assessment, time management, critical thinking
Preferred skills
Veeva Vault Clinical (eTMF/CTMS), SAP, advanced degree in Life Science
Technologies
Veeva Vault Clinical, CTMS, SAP, SharePoint, MS Office suite
Responsibilities
Prepare and format clinical trial submission documents adhering to regulatory guidelines; partner with Submission Managers on timing and creation of submission artifacts; create site numbers and enter milestones/approval dates; reconcile Veeva systems for data accuracy; manage drug shipment addresses in SAP; drive problem-solving and mitigation strategies; provide guidance on SOPs and regulatory legislation; manage interactions with senior multifunctional teams.
Seniority
Mid-level, hands-on IC
