Clinical Operations Manager

vor 4 Wochen

Bern, Schweiz Pharmiweb Vollzeit

Hobson Prior is seeking a Clinical Operations Manager for a contract position based in Allschwill. The successful candidate will be responsible for driving the development of operational trial-related documents and procedures, as well as managing External Service Providers (ESPs) and supervising their deliverables. This role may require international travel.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

  • Manage operational trial-related activities such as site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, and submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs).
  • Lead the development of ESP specifications, testing and implementation, and ensure appropriate quality control of deliverables.
  • Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol.
  • Lead the development of trial-related operational documents.
  • Resolve operational issues in a proactive and timely fashion.
  • Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained.
  • Approve invoices (e.g. site payments) and ensure related payments in a timely manner.
  • Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection.
  • Actively participate in Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.
  • Mentor team members as needed.

Requirements

  • Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
  • Experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report.
  • Experience in working in global cross-functional (matrix) and multicultural teams.
  • Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
  • Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
  • Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
  • Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).
  • Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities.
  • Strong interpersonal, communication (written and verbal), collaboration and organizational skills.
  • Self-motivated and able to work independently and proactively.
  • Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment.
  • Demonstrate ownership and initiative, decision-making, working flexibility and problem-solving skills.
  • Demonstrate ability to work in multi-functional and cross-functional teams: effective teamwork and collaborative relationships.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By providing your details and submitting this form, you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy.

  • Clinical Research Associate/clinical Trial Manager

    vor 3 Wochen

    Bern, Schweiz InnoMedica Holding AG Vollzeit

    **INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...

  • Clinical Research Associate/clinical Trial Manager

    Vor 5 Tagen

    Bern, Bern, Schweiz InnoMedica Holding AG Vollzeit

    **INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reiheerfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigenerReinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystemund umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...

  • Clinical Trial Manager

    vor 3 Wochen

    Bern, Schweiz InnoMedica Holding AG Vollzeit

    **INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...

  • Clinical Trial Manager

    Vor 5 Tagen

    Bern, Bern, Schweiz InnoMedica Holding AG Vollzeit

    **INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reiheerfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigenerReinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystemund umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...

  • Clinical Trial Manager

    Vor 5 Tagen

    Bern, Schweiz InnoMedica Holding AG Vollzeit

    **INNOMEDICA IS A YOUNG NANOTECH COMPANY **with 50 employees, a number of promising drugs in preclinical and clinical development and its own clean room production. in the fields of oncology (gentle chemotherapy) and neurology (new approach to treat Parkinson's disease). In order to conduct further clinical trials with our Clinical Research Team based in...

  • Clinical Trial Manager

    Vor 5 Tagen

    Bern, Bern, Schweiz InnoMedica Holding AG Vollzeit

    INNOMEDICA IS A YOUNG NANOTECH COMPANY with 50 employees, a number ofpromising drugs in preclinical and clinical development and its own clean room production.in the fields of oncology (gentle chemotherapy) and neurology (new approach to treatParkinson's disease).In order to conduct further clinical trials with our Clinical Research Team based in Bern, weare...

  • Director, Clinical Portfolio Execution

    vor 4 Wochen

    Bern, Schweiz CSL Vollzeit

    Description CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to...

  • Director, Clinical Portfolio Execution

    vor 3 Wochen

    Bern, Schweiz CSL Vollzeit

    Description CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to...

  • Director, Clinical Portfolio Execution

    Vor 5 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Description CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to...

  • Clinical Data Manager

    vor 2 Monaten

    Bern, Schweiz Universität Bern Universität Bern Vollzeit

    **Clinical Data Manager** **80-100%**: Anstellung per 1. Mai 2024 oder nach Vereinbarung Die Clinical Trials Unit Bern (CTU Bern) ist eine Unit des Departements für klinische Forschung (DCR) und arbeitet als Studienkoordinationszentrum der Medizinischen Fakultät eng mit dem angegliederten Universitätsspital (Inselspital) zusammen. Sie dient primär als...

  • Clinical Data Manager

    vor 3 Wochen

    Bern, Schweiz Universität Bern Universität Bern Vollzeit

    **Clinical Data Manager** **80-100%**: Anstellung per 1. Mai 2024 oder nach Vereinbarung Die Clinical Trials Unit Bern (CTU Bern) ist eine Unit des Departements für klinische Forschung (DCR) und arbeitet als Studienkoordinationszentrum der Medizinischen Fakultät eng mit dem angegliederten Universitätsspital (Inselspital) zusammen. Sie dient primär als...

  • Manager GMP Operations

    vor 4 Wochen

    Bern, Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the world... one person at a time" ... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion...

  • Clinical Data Manager

    Vor 5 Tagen

    Bern, Bern, Schweiz Universität Bern Universität Bern Vollzeit

    **Clinical Data Manager****80-100%**:Anstellung per 1. Mai 2024 oder nach VereinbarungDie Clinical Trials Unit Bern (CTU Bern) ist eine Unit des Departements für klinische Forschung (DCR) und arbeitet als Studienkoordinationszentrum der Medizinischen Fakultät eng mit dem angegliederten Universitätsspital (Inselspital) zusammen. Sie dient primär als...

  • Head of Clinical Affairs

    Vor 5 Tagen

    Bern, Bern, Schweiz Proclinical Vollzeit

    Proclinical are working exclusively with a start-up medical device company focusing on Cardiology. The role is on a contract basis but is open to perm.We are looking for an experienced Head of Clinical Operations/Affairs to join this small team and set up the global study operations.This is a pivotal trial across the EU and US, and you will need:Demonstrable...

  • Senior Clinical Quality Assurance Manager

    vor 2 Monaten

    Bern, Schweiz Pharmiweb Vollzeit

    RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Senior Clinical Quality Assurance Manager on a 12 month contract in Switzerland. This company discovers, develops, and commercializes medicines across a wide variety of therapeutic areas.This role will be a 12 month, 1 FTE contract and it will be hybrid working...

  • Academic Clinical Project Manager

    Vor 5 Tagen

    Bern, Bern, Schweiz Insel Gruppe Vollzeit

    Department of Internal MedicineUniversity Hospital for Hematology:*** % | in Bern:***Entry on limited to two years:***We are seeking an Academic Project Manager to complete our team and support the International Hereditary TTP Registry. Hereditary thrombotic thrombocytopenic purpura (hTTP) is a rare congenital disease caused by a severe ADAMTS13 deficiency...

  • Manager, Feasibility

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    Summary: The Manager, Feasibility & Recruitment Strategy within the Clinical Development Operation; Global Feasibility and Start-up group is responsible for feasibility mobilization, country and site feasibility as well as enrollment planning activities in support of the Clinical studies. This position will oversee the framework for ensuring study planning...

  • Sr Manager Gmp Operations

    Vor 7 Tagen

    Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Sr Manager Gmp Operations

    Vor 5 Tagen

    Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Clinical Research Manager

    vor 1 Monat

    Bern, Bern, Schweiz Insel Gruppe SA Vollzeit

    Berne, %The Swiss Center for Brain Health and Stroke, formerly Stroke Research Center Bern is a world-renowned nucleus of excellence for high-quality patient-oriented clinical research spearheading major breakthroughs in stroke care (mechanical thrombectomy, management of hemorrhagic stroke, dissections and cerebral venous thrombosis). In cooperation with...