Christopher Kisenda
- Role
- Clinical Document Specialist at Replimune
- Location
- Norristown, PA, US
- LinkedIn followers
- 500 followers
About Christopher Kisenda
Energetic, detail-oriented individual with over 5 years of experience in clinical…
Experience
Clinical Document Specialist
Nov 2022 — Present
Responsible for set-up, maintenance, document quality control (QC) review, completion and archiving of eTMF documents for Replimune trials - Responsible for processing eTMF documentation and performing quality control (QC) review in accordance with Replimune standard operating procedures (SOPs), ICH-GCP guidelines, eTMF reference model and study specific eTMF Plans - Ensure eTMF documents meet good documentation practices (GDP) by confirming ALCOA+(Attributable, Legible, Contemporaneous, Original, Accurate and Complete) principles - Remediates issues and/or discrepancies identified with eTMF content, directly with the Replimune cross-functional teams and Contract Research Organizations (CROs) as applicable - Play a critical role in eTMF document management activities in accordance with eTMF Operations processes and procedures to ensure the eTMF is audit and inspection ready - Collaborate cross-functionally across the organization, ensuring that all documents necessary to provide an accurate reconstruction of the trial are identified and collected - Perform comprehensive completeness reviews inclusive of cross-referencing, ensuring documentation is filed according to the Replimune eTMF Index and eTMF Plan - Effectively manage documents residing in various locations with different filing structures - Ensure the Replimune eTMF is always ‘inspection ready’ and documents are filed contemporaneously, in accordance with established timelines - Ensure documents which fail quality review are effectively remediated and indicated as resolved/closed - Represent eTMF Operations at study team meetings, participate in collaborative efforts, and play an important cross-functional role in eTMF document retrieval and management - Provide support to eTMF Operations during audits and/or regulatory inspections - Identify trends and escalate concerns to eTMF Sr - Adhere to eTMF SOPs, KPIs, and relevant eTMF process-supporting guidance
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