Trial Master File Manager

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Act as the Clinical Operations Veeva Vault Clinical process owner and TMF subject matter expert • Lead development, deployment, maintenance, and continuous improvement of eTMF and CTMS processes, SOPs, Work Instructions, training materials, tools, and filing guidance • Set up, organize, maintain, and archive study-specific eTMF, CTMS records, and SharePoint repositories for Phase I–IV studies • Ensure clinical documentation is filed and archived according to SOPs, GCP, ICH guidelines, and retention requirements • Maintain inventory reports and tracking systems for archived paper records • Establish study dashboards and organize Veeva Vault Clinical reports for study-, country-, and site-level metrics and TMF health • Support integration between Veeva Vault Clinical and other clinical systems, including EDC platforms and CRO partner systems • Collaborate with Veeva Administrators on system configuration, testing, validation, and rollout of new functionality • Oversee clinical-system user access, role assignment, access reviews, and access changes • Maintain and periodically review BioCryst’s standard TMF Index • Conduct and oversee risk-based reviews of internally managed and CRO-managed TMFs; identify issues, escalate risks, track deficiencies, and implement corrective actions or retraining • Prepare for and support internal/external audits and regulatory inspections, including document retrieval, issue management, response coordination, and corrective-action verification • Develop and deliver training on TMF processes, filing expectations, system updates, regulatory and archival requirements • Serve as point of contact for TMF filing and document-management questions • Collaborate with clinical, regulatory, quality, data, safety, supply-chain, CRO, and other partners to keep TMFs current, complete, high quality, and inspection ready • Identify operational needs and implement solutions improving document quality, compliance, efficiency, and departmental effectiveness • Work independently, adapt to changing priorities, exercise judgment, and take initiative • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree with 7–10 years of relevant clinical research or pharmaceutical industry experience, including a minimum of 5 years of direct TMF/eTMF experience and demonstrated experience leading TMF processes, systems, vendor oversight, and inspection-readiness activities; or an equivalent combination of education and experience • Hands-on experience with the DIA TMF Reference Model and the Veeva Vault Clinical application, including the eTMF and aspects of the CTMS • Experience with audits, regulatory inspections, CRO oversight, system implementation, training and process improvement • Knowledge of Good Clinical Practice (GCP) regulatory requirements and International Conference on Harmonization (ICH) guidelines • Ability to identify team needs and suggest/implement solutions for improved departmental functionality • Must be a highly motivated self-starter who is capable of taking initiative and sees projects through to completion with minimal supervision • Must be proficient in computer software systems such as word processing, spreadsheet, and database systems