inVentiv Health 0000102580-Manager TMF-Interim in New Jersey
Manager TMF Operations is responsible for ensuring completeness, quality and accuracy of assigned Trial Master Files for company’s clinical trials and ensures they are “inspection ready”. Establishes relevant procedures and processes, and performs quality control review for study documents, as well as aggregated regulatory data included in regulatory submissions. Oversees and assigns for processing incoming of clinical study documents from clinical research organizations (CROs) and company functional areas (e.g. Clinical Operations, Regulatory Affairs), including paper records. Represents TMF Operations in internal and external meetings involving management of clinical study TMFs. Interfaces with CROs, clinical operations, regulatory affairs and other groups throughout company to resolve TMF issues. Ensures management of study TMFs are in compliance with company’s SOPs and polices. If necessary, substitutes for the Director at TMF related meetings.
• Performing quality control checks on documents generated by all functional groups within DS and external partners who submit TMF documents into Veeva eTMF Vault and place in the QC workflow.
• Effectively communicating internal compliance metrics with managers and other colleagues within clinical and regulatory operations as well as COMPANY affiliates and CRO(s) performing Trial Master File tasks on behalf of COMPANY, to improve and maintain data quality for DS studies.
• Manages TMF Operations contractors to ensure compliance with established TMF management procedures and policies.
• Performing quality control checks on documents generated by all functional groups within DS and external partners who submit TMF documents into Veeva eTMF Vault and place in the QC workflow by producing metrics to be shared with management.
• Provides leadership and work guidance to both internal DS personnel and contractors, remotely located contractors, and CRO/vendor staff to answer questions, triage problems and requests regarding system support issues with Veeva eTMF Vault support vendors.
• Responsible for assigned TMF process improvement initiatives and implementing new processes utilizing key technologies. Oversees and provides assistance in the evaluation of processes to ensure organizational responsibilities are met.
• Supports design and configuration changes of the DS Veeva eTMF Vault system. Contributes as an ad hoc member of the Veeva eTMF Vault change control board. Participate in the Veeva eTMF Vault Users Group across DS regions.
• For each new clinical trial work directly or oversee the work with functional groups to ensure associated TMF management processes are in alignment with established DS processes.
Please send resume to firstname.lastname@example.org
• Bachelor's degree in life sciences, business, or related field preferred or equivalent combination of education and experience
• 6 or more years of experience in information or document management in an end user computing environment. Experience working with records management and archival procedures. Experience working with validated system implementations and Pharma/Health Care organizational processes
• Detailed knowledge of Regulatory/Clinical documents.
• 3+ years of experience working with clinical trial documentation.
• Experience working in an eTMF system is preferred; Veeva Vault preferred.
For further details or to apply for this job, please contact:email@example.com
inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.