An opportunity exists for an ambitious professional to be part of the clinical operations team in support of Xcovery. Xcovery is a biopharmaceutical company working to improve the lives of patients by discovering medicines to develop a pipeline of oncology therapies. This position offers the right candidate a significant opportunity for career development and growth.
The Trial Master File (TMF) Manager works closely with internal team members and vendors to ensure the integrity of the clinical Trial Master File.
Primary Responsibilities include but are not limited to the following:
Coordinate Quality Control reviews of study PMF/TMFs to ensure they are of the highest quality and inspection ready, and meet compliance specifications according to regional regulations and ICH guidelines
Manage CRO TMF interactions, including sponsor oversight of relevant TMF functional activities
Manage the activities associated with the TMF business process, including continuous improvement activities and metrics, and archiving Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection
Assist with the oversight of the eTMF vendor and related TMF setup and maintenance processes
Liaise with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF
The TMF manager will serve as Lead for one of the main processes within the department
Assist in the preparation of clinical trials documents for internal audit and inspections
Responsible for the eTMF lock
Facilitate the writing or update of departmental SOPs and SWPs as needed
Provide feedback to project teams and /or management for the correction and resolution of document quality issues, TMF completeness and timely submission of documents to the TMF
Follow corrections/resolutions until final
Manage the local activities related to archiving of TMF documents
Education and Skills Requirements:
• BS/BA degree or equivalent (background in life sciences preferred). • 4 + yrs. of industry experience (biotech/pharma/ CRO) with at least 2 years of experience working with a Trial Master File • Have a background working with Trial Master File documents, extensive knowledge of Essential Documents is required • Strong understanding of ICH, GCP and relevant regulatory requirements • Strong operational and management skills with attention to detail • Results driven in terms of timelines and quality • Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
Please submit your Resume/CV, salary history and cover letter.
Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. Xcovery’s lead product, X-396, is a small molecule that inhibits anaplastic lymphoma kinase (ALK). X-396 is being investigated for the treatment of ALK positi...ve non-small cell lung cancer. The Company is currently enrolling patients in its Phase 2 and Phase 3 human clinical trials. Xcovery is also developing MET and PI3K/mTOR kinase inhibitors for advanced tumors.