Senior Documentation Specialist
Alentis Therapeutics · Allschwil
Job description
About this position
As the Senior Documentation Specialist, you ensure the effective management, quality, completeness, and inspection readiness of essential clinical trial documentation for assigned studies, programmes or documentation activities, including the sponsor TMF and oversight of CRO and laboratory TMFs. You acts as an experienced TMF specialist, working closely with Clinical Operations and cross-functional study teams to provide expert guidance on document processes, compliance, risk management and continuous improvement.
Your tasks:
Oversee documentation handling, filing and archival activities for assigned studies, programmes or documentation activities across relevant functional areas, ensuring that final documents are complete, accurate, traceable and maintained in the company document management system.
Perform complex quality-control reviews and provide technical oversight of QC activities completed by TMF colleagues and external partners, in accordance with applicable SOPs, the CDISC TMF Reference Model, study-specific TMF Plans and regulatory requirements.
Plan and conduct risk-based periodic oversight reviews of CRO and laboratory TMFs; identify quality or completeness issues, recommend remediation actions, monitor progress and escalate significant or recurring risks.
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Lead TMF inspection-readiness activities for assigned studies and coordinate documentation support during audits and regulatory inspections; develop and coordinate documentation-related corrective and preventive actions, monitor implementation and verify effective closure.
Act as a TMF subject matter expert for study teams and external partners, providing practical guidance and escalating matters that require management direction or cross-functional decisions.
Analyse and communicate TMF quality and performance metrics, identify trends and recommend improvements to processes, systems, templates and ways of working.
Ensure assigned activities comply with company and CRO SOPs, ICH GCP, applicable regulations and relevant regulatory guidance.
Represent Clinical Documentation in study meetings, provide input on TMF status and quality, and follow up on agreed documentation actions, decisions and risks.
Prepare and deliver TMF guidance and training, and share expertise with study-team members and other TMF colleagues on compliant documentation practices.
Role requirements
Bachelor’s degree in a scientific, health-related or other relevant discipline.
Minimum seven years of experience in TMF and documentation management within the pharmaceutical or CRO industry, including at least three years of experience in biotechnology or another fast-growing, dynamic environment.
Advanced knowledge of eTMF solutions, such as Veeva Vault Clinical, PhlexTMF or comparable platforms, together with strong working knowledge of ICH GCP, applicable regulations and the CDISC TMF Reference Model.
Demonstrated experience in TMF quality control, risk-based TMF reviews and CRO or vendor oversight.
Demonstrated experience leading TMF inspection-readiness activities and managing documentation-related findings and corrective and preventive actions.
Strong stakeholder-management and communication skills, with the ability to provide clear guidance, influence without direct authority and build effective working relationships across functions.
Proactive and accountable approach, with sound judgement, analytical problem-solving skills and the ability to identify and implement pragmatic, GCP-compliant solutions.
Excellent attention to detail, organisation and time management, with the ability to prioritise and manage multiple activities in a dynamic environment.
Professional proficiency in written and spoken English.
Work permit
Candidate needs to hold a Swiss work permit or be an EU citizen eligible to work in Switzerland
Your path forward
If you meet most of these requirements and bring a strong dedication to technical documentation, we encourage you to apply. You will contribute directly to our mission of advancing new medicines for patients.
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