Job Description
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.
Here: https://apply.workable.com/debiopharm-group-sa/
For our Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a
Clinical Operational Specialist
The Clinical Operational Specialist is a member of the Clinical Trial Team supporting the delivery of clinical trials. The COS is responsible for the delegated operational activities of a clinical trial from planning through close-out under the leadership the Clinical Trial Leader (CTL).
Main responsibilities:
- Coordinates and participates in Clinical Trial Team meetings and prepares meeting minutes, and tracks and follows up on outstanding actions.
- Ensures all delegated operational trial deliverables are met according to timelines, budget, operational procedures, and quality standards.
- Sets up and maintains accurate trial information in tracking systems and communication tools for updating the relevant internal/external boards (e.g., Core Team, Development Leadership Team, and Core Team). Trains and provides guidance to Clinical Trial Team members in the use of these systems.
- Develops and oversees the execution of IRB/IEC submission plan for initial protocol and its amendment(s) for the trial.
- Works in collaboration with Clinical Team Members and TMF Specialist on the set-up, maintenance, close-out and archiving of the Trial Master File. Coordinates regular quality check and review of TMF ensuring continual inspection readiness.
- Sets up and maintains clinical trial insurance in participating countries.
- Establishes and maintains trial-related processes/systems (e.g., central laboratories, interactive response technologies (IRT), clinical supplies, etc.) with the CRO/vendors as assigned per protocol requirements.
- Manages and oversees the activities of the CRO/vendors as assigned including the interactions between the Clinical Trial Team and the CRO/vendors.
- Assists in the tracking, processing, and reconciliation of invoices from the CRO/vendors and generating purchasing order according to the CRO/vendor contracts.
- Leads the arrangement and contributes to the preparation of external meetings e.g., monitor meetings, investigator meetings, and advisory boards.
- Ensures trial inspection/audit readiness and participates in internal audits and inspections as required.
- Prepares and distributes trial related correspondence. Contributes to and distributes materials for meetings, newsletters, and websites.
- Contributes to process improvement or acts as Subject Matter Experts for training or SOPs.
- Coaches new Clinical Operational Specialists during their onboarding as assigned.
Requirements
Your profile
- Bachelor’s Degree/Master’s Degree in Science or Healthcare
- 3 years of experience in pharmaceutical industry, preferably in clinical research
- Possess good knowledge of Good Clinical Practice and end-to-end clinical trial process including the interfaces
- Ability to work in a matrix organization and demonstrated collaboration skills
- Ability to coordinate and prioritize multiple tasks and deliverables
- High degree of flexibility and demonstrated strong verbal and written communication
- Strong organization and tracking skills
- Computer proficiency, good computer skills in managing daily tasks
- Fluent in English (French and another European language are an asset)
Benefits
Debiopharm offers employees:
- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.