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Senior Trial Master File Study Owner - Dacorum, United Kingdom - Pharmalex
Description
Are you a Trial Master File expert looking for your next role? Then, Cencora Pharmalex is your career opportunityCencora PharmaLex is looking for an experienced Senior Trial Master File Study Owner to work within our Professional Services team on a full-time, 6 month fixed-term contract.
Travel is not an expectation of the role, however occasional travel may be required depending on customer requirements, for example in the case of an inspection or to complete paper TMF activities.
Candidates must be based in the UK for this opportunity and be available to start on 23rd May 2024.About us: Are you looking for a dynamic company with daily new challenges and opportunities?Then, Cencora Pharmalex is your career opportunity. Cencora Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. Customers place their trust in Cencora Pharmalex because of our proven mastery over the TMF-related questions and challenges they face every day.
About the role: The Senior Trial Master File Study Owner provides pivotal support and subject matter expertise (SME) at a study level, proactively ensuring our clients' Trial Master Files (TMFs) are achieving an inspection ready state. They are an integral part of the study team, becoming a single point of contact to help maintain TMF health, consistency, and compliance across clinical trials within the organisation.
What are we offering our Senior Trial Master File Study Owner?The salary will be commensurate with the candidate's experience25 days holiday plus BH (increasing to 27 after qualifying service)8% employer pension contribution (pro rata)
An opportunity to work within an organisation with a positive work/life balance environmentContinuous development opportunities through knowledge and experience as well as trainingKey responsibilities as our Senior Trial Master File Study Owner:
Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices.
Support the setup of the study-specific TMF structure, liaising with the Study Team to establish requirementsMonitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implementedWrite/initiate creation of the study-specific TMF Management Plan in collaboration with Study TeamEnsure ongoing adherence to TMF SOPs and specificationsCreate study-specific TMF Index (or equivalent)Perform and/or support Quality Review and perform spot-checks for quality oversightProvide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintainingHelp facilitate, track, and support periodic Study Team TMF ReviewsPerform a deep-dive of report outputs; identify and share trends and risk areas with Study TeamsManage remediation and reconciliation projectsSupport audits and inspectionsSupport implementation of CAPAs at study levelIdentify and escalate risk and trends impacting Inspection ReadinessFacilitate TMF-focused communication and collaboration between Sponsor and CROsCommunicate to the Study Manager (or equivalent) on all aspects of the TMFBuild proactive relationships with study teams, providing continued SME supportUnderstand and utilise appropriate escalation pathwaysAct as TMF SME, including related processes, to provide ongoing support to Study TeamConduct training for Study Team and/or colleagues, either 121 or in group settingWhat we're looking for in our Senior Trial Master File Study Owner:5 years relevant industry experience in Clinical or TMF Operations oversight is essential
Excellent knowledge of: Good Documentation Practices (GDP)
Document recognitionGood knowledge of:
Referencing/Applying applicable resourcesWorking knowledge of: Clinical trial lifecycleTMF Reference Model (or equivalent)eTMF systemsTMF Health & Metrics, including Quality Review processInternal communication/escalation pathwaysFamiliar with: TMF lifecycleOther clinical/document management systemsTMF stakeholdersEnd to end tasks, including TMF set-up process and Management PlansTMF trainingInspection ReadinessExternal communication/escalation pathwaysTo join our team as a Senior Trial Master File Study Owner, please click 'apply' now.
Cencora Pharmalex is an equal opportunity employer and welcomes everyone to join our growing team.
At Cencora Pharmalex we make sure that we comply equality, diversity and inclusion in all our offices and prohibit against any discrimination on basis of race, religion, colour, sex, age, marital status or disability status etc.
No agencies please
