Clinical Document and Trial Master File (TMF) Specialist (50)
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Job Location:
Arlesheim - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Alentis Therapeutics the Claudin-1 Company is on a mission to treat cancer and reverse fibrosis. To this end we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney liver and lung fibrosis.
Tasks
In this role you will be responsible for the overall management quality and maintenance of essential clinical trial and other designated documents including the set up and maintenance of the TMF with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs and ICH/GCP/TMF guidelines. This position plays a key role in both paper and electronic global TMF system management by filing organizing and maintaining paper and/or digital records and coordinating the document management activities performed by third parties such as CROs vendors clinical sites collaborators as well as other internal and external team members to achieve inspection readiness in close collaboration with cross-functional teams for both Fibrosis and Oncology programs.
Your tasks:
- Expanding and leading the company documentation handling and filing processes across functional areas (e.g. Clinical Legal Finance). Handling filing and tracking of final documents in the company documentation management system
- Leading the completion of the study specific sponsor TMF Plan and review of the CRO TMF plan and index in association with the TMF Owner
- Overseeing the set-up maintenance and archival of the study Trial Master File
- Performing quality control (QC) review of documents to be filed in the sponsor documentation system as well as in the CRO eTMF in accordance with standard operating procedures (SOPs) DIA TMF Reference Model and study specific TMF Plans
- Conducting periodic oversight QC of the CROs TMF to identify documentation gaps and quality issues and to initiate corrective actions
- Acting as the point of contact for audits/inspections related to the Trial Master File processes and activities and assisting with the development of corrective action plans related to Trial Master File findings
- Serving as TMF Subject Matter Expert to study teams and external partners
- Ensuring effective communication cross-functionally and issue escalation across TMF stakeholders
- Conducting all activities in compliance with Client and CRO SOPs and other regulatory guidance documents
- Creation and maintenance of trial budget reconciliation tools. Filing and tracking of invoices from vendors/consultants including oversight of investigator payment process
- Creation and maintenance of legal document tracking tools e.g. CDAs MSAs workorders etc. and filing of final legal documents in the companies document management system
- May support the completion and maintenance of public registries in collaboration with Clinical or Business Development team leads
- Performing other activities as assigned
- Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.
Requirements
- Bachelors Degree required in science/health-related field
- 5 years working experience in the biotech and pharma industry
- A minimum of 3 years experience with electronic Trial Master Files (eTMF) solutions (Veeva Vault Clinical PhlexTMF other eTMF platforms) is a must
- Solid experience with the DIA TMF Reference Model ALCOA standard and document management best practices is mandatory
- Broad understanding of records management requirements in Drug Development
- Experience performing Quality Control of TMF documents and CRO oversight QCs
- Experience supporting audits and regulatory inspections
- Familiarity with various aspects of clinical trials and regulatory requirements for clinical trials (ICH/GCP FDA EU-CTR).
- Basic understanding of the clinical trial budget and reconciliation process is an asset
- Pro-active attitude acting with sense-of-urgency and applying an entrepreneurial mindset
- Ability to think analytically identify problems as they are occurring (proactive management) and rapidly identify and implement solutions that are GCP compliant
- Excellent organizational and planning skills including strong attention to detail
- Strong interpersonal skills. Ability to collaborate effectively with the study team cross-functional team members and external partners (CROs vendors)
- Excellent communication skills. Proficiency in English (written and oral)
- Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland
Benefits
We offer a competitive salary and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team please submit your CV.
Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The working place is Allschwil Switzerland with maximal 1 day home office per week.
Key Skills
- DRG
- Acute Care
- Adobe Acrobat
- ICD-10
- Records Management
- Technical Writing
- Clinical Documentation Improvement
- Documentation Review
- Sharepoint
- cGMP
- Document Management Systems
- Document Management
About Company
Alentis Therapeutics is a clinical-stage biopharmaceutical company developing breakthrough treatments for cancer and fibrotic diseases.
