Clinical Document and Trial Master File (TMF) Specialist (80 100)

Arlesheim - Switzerland

Monthly Salary: Not Disclosed

Posted on: Yesterday

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

Your tasks:

Assist in the overall management quality control and maintenance of essential clinical trials and other designated documents. including the maintenance of the sponsor TMF and CRO TMF oversight
Support the company documentation handling and filing processes across functional areas (e.g. Clinical Business Development Laboratory etc...). Assist in the handling filing and tracking of final documents in the company documentation management system
Support performing quality control (QC) review of documents to be filed in the sponsor eTMF system in accordance with standard operating procedures (SOPs) DIA TMF Reference Model and study specific TMF Plans
Support in the conduct of periodic oversight QC of the CROs and Laboratories TMF
Assist in activities related to 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
Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.
Support the documentation and TMF Specialist in the day-to-day operational management and coordination of TMF activities (Quality control archiving indexing etc.)
Participate in study meetings and contribute to study status tracking meeting minutes and documentation clinical document review laboratory sample tracking and managementWorking alongside other clinical operations professionals (e.g. CTMs/CTLs) supporting them in the operational execution of clinical trials (document and process implementation study status and progress monitoring compliance documentation etc.)

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 2 days home office per week.

Tasks

Your tasks:

Assist in the overall management quality control and maintenance of essential clinical trials and other designated documents. including the maintenance of the sponsor TMF and CRO TMF oversight
Support the company documentation handling and filing processes across functional areas (e.g. Clinical Business Development Laboratory etc...). Assist in the handling filing and tracking of final documents in the company documentation management system
Support performing quality control (QC) review of documents to be filed in the sponsor eTMF system in accordance with standard operating procedures (SOPs) DIA TMF Reference Model and study specific TMF Plans
Support in the conduct of periodic oversight QC of the CROs and Laboratories TMF
Assist in activities related to 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
Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.
Support the documentation and TMF Specialist in the day-to-day operational management and coordination of TMF activities (Quality control archiving indexing etc.)
Participate in study meetings and contribute to study status tracking meeting minutes and documentation clinical document review laboratory sample tracking and managementWorking alongside other clinical operations professionals (e.g. CTMs/CTLs) supporting them in the operational execution of clinical trials (document and process implementation study status and progress monitoring compliance documentation etc.)

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

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 2 days home office per week.