Clinical Trial Coordinator

vor 3 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._

For our Clinical Operations ganization based at our Headquarters in Lausanne, we are looking for a

**Clinical Trial Coordinator**

**Mission**:
The Clinical Trial Coordinator (CTC) is involved in the set-up, maintenance and closure activities of assigned Phase I /II /III clinical trials (Study), and actively supports the Clinical Trial Manager (CTM) and the study team in the creation, update, and distribution of study materials, tools and documents. The CTC contributes to the Clinical Operations (ClinOps) department, project team and study team goals.

**Your responsibilities will be but not limited to**:

- Provide the logistics associated to internal and/or external study meetings and generat, finalise and distribute internal meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation
- Setup the internal Study Sharpoint and the external Sharepoints of ClinOps vendors as needed. Ensure a consistent structure and filling method per the current template
- In collaboration with the TMF Specialist, set up and maintain Study eTMF in the Sponsor Electronic Domument Management System(s). Be responsible for any TMF transfer as required. Take responsibility to ensure the essential Clinical Operations Study documents are filed in the eTMF per the TMF Plan requirements and SOPs / Ols. Esure inspection readiness of the TMF by assessing TMF status via dashboard and metrics.
- Provide the logistics associated to internal and/or external study meetings and generate, finalise and distribute internal meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation.
- Verify vendors’ work orders and/or change orders. Reconcile invoices on an ongoing basis, follow up invoices issues with vendors and Study sites if applicable.
- Ensure regular review of Study budget, forecasts and accruals in collaboration with the CTM. Collect, challenge and consolidate initial Study budget and update it as needed, upon request and under supervision of the CTM.
- In case of short / unexpected absences of the CTM, act as back-up and primary point of contact of the Study by directing the action items to the most appropriate person.
- Contribute to the quality of Study activities and key steps of the Study deliverables, according to the ICH GCP and local applicable regulations, and in accordance with applicable SOPs/OIs.
- Set up and maintain Study trackers and necessary reporting tools as applicable.
- Author/Owner of the study-specific TMF Plan and Oversight Plan; draft the plans and lead the review cycles until document finalisation and approval.
- Assist the CTM in communicating internally the study progression within the company. Draft newsletters for in-house studies and/or review the drafts sent by the CROs for sponsor approval.
- Coordinate the requests and follow-up of Debiopharm International’s clinical trial liability insurances.
- Coordinate and/or contribute to the set up and maintenance of Debiopharm International’s Clinical Studies in ClinicalTrials.gov.
- For in-house studies, may support CRA(s) activities such as creation/distribution of study binders, feasibility activities, preparation of submissions to Health Authorities and/or Ethics Committees.
- May attend or lead non-study related meetings, capture actions and take minutes.
- May participate in site feasibility activities under CTM responsibility.
- May support the writing or review of Study plans and other Study documents, under CTM oversight.
- May coordinate issues resolution with vendors or manage vendors under supervision of the CTM.

**Requirements**:

- Bachelor/Master degree or equivalent in a relevant discipline.
- Minimum 2 years of experience in Clinical Operations or relevant R&D field in Pharma/CRO/healthcare.
- Good Knowledge of ICH GCP and the drug development regulatory environment
- Language skills: excellent spoken and written English. French is an advantage.
- Collaborativ

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