Offres d'emploi à distance et à domicile à Basel

Hybrid Clinical Operations Manager Clinical Operations Manager

Vectura Fertin Pharma · Basel (Remote) · Switzerland · Hybrid

About the job

Who We Are

Vectura Fertin Pharma is a new business, bringing together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. We are driven by the exciting and unique goal of Revitalizing, Repurposing and Reimagining existing therapies to address some of today’s unmet patient and consumer needs and to better serve people in taking care of their health.

What We Will Deliver

We aim to build upon products that exist today and make them better for patients and consumers tomorrow. By taking a holistic and human-centric approach to care, Vectura Fertin Pharma will innovate the design and delivery of medicines and Consumer Health products that support overall health and wellness management. We will focus on the end-to-end development of a proprietary pipeline of Prescription, Over-The-Counter (OTC) and Consumer products, with a specific focus on areas where we believe we can deliver best-in-class, and highly differentiated products that address existing unmet medical needs.

Healthcare: Develop and launch fast acting, effective and safe treatments in the field of cardiovascular diseases, neurology, pain management and others, all of which can be delivered via innovative technologies.

Wellness: Bring to market scientifically substantiated botanical products that help people take well-being into their own hands in the areas of Sleep, Energy, and Mental Health.

About the role:

As a Clinical Operations Manager, you will be required to drive and be involved hands-on when necessary in the setup and execution of the clinical trials. Success will, in part, be defined by efficient execution, high quality and timely deliverables of all associated aspects of the clinical trials, in compliance with company’s SOPs, Good Clinical Practice guidelines and any other relevant regulation. This role can be based in Switzerland or the UK.

Core responsibilities:

Responsible for trial management to ensure all aspects of trials phase I-IV are executed as planned, within timelines and budget:

  • Own the quality, timelines, execution and deliverables of the allocated clinical trials
  • Manage and coordinate the internal and external vendors involved in the clinical trial set up, including but not limited to: CRO, analytical labs, CMC, etc
  • Participate in review of site contracts and budget negotiations with external parties (e.g CRO, bioanalytical lab, etc)
  • Establish the Sponsor Trial Master File (including essential and non-essential document collection from CRO and other related parties) in a timely manner and ensure ongoing maintenance, close out, and regular quality control of the TMFs, including managing the reconciliation process, in compliance with company’s SOPs and GCP.
  • Provide assistance with internal and external meetings.
  • Organize study team internal meetings, including meeting minutes.
  • Data Quality and Compliance
  • Responsible for creating, disseminating, and evaluating metrics reports (i.e. enrollment, outstanding query and data reports, site startup status, etc.)
  • Identify and escalate potential risks to Line Manager
  • Establish relationship with study site personnel specifically, a study nurse to keep track of patient enrollment and treatment schedules. Ensure patient follow-ups for clinical results are received in timely manner
  • Facilitate the distribution and tracking of trial supplies; maintain investigational product accountability and traceability, as needed
  • Reporting status of the trial to senior management
  • Ensure the conduct of the study is in compliance with the currently approved protocol/amendment(s), with current GCP guidelines and with applicable regulatory requirements.
  • Perform other duties as assigned to ensure successful management and completion of clinical trial

Role Requirements:

Personal characteristics will be crucial, as the successful individual needs to have the self-sufficiency, energy, and drive to take this opportunity and run with it, with exceptional communication and leadership skills, as well as a level of comfort at working in a fast-paced, launch-oriented setting. Specifically, the ideal candidate will possess the following:

  • Minimum 5 years direct experience in planning and hands on managing all phases of clinical trials
  • Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
  • Experience in CRO management
  • Experience in managing IMP supplies management at the global level (vendors providing background meds, the standard of care medications, etc.)
  • Experience with global trial budgets including development, negotiation, and completion of Clinical Trial Research Agreements
  • Excellent oral and written communication, organizational and planning skills; maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects
  • Detail-oriented, hands-on mentality and comfortable with broad responsibilities in an entrepreneurial, fast-paced, rapidly growing complex company environment.
  • Travel to sites when necessary

Why Join Us?

We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes.

As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings. We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.

Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.