Clinical Operations Manager

vor 2 Wochen

Luzern, Schweiz MSD Vollzeit

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

In this position you are working for a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines. The company has longstanding commitment to prevent and treat diseases and invests significantly in research and development to address unmet public health needs with innovative treatment options. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

As an addition to our Global Clinical Trial Operations Team based in Lucerne, we are looking for a **_Clinical Operations Manager (COM)_**.

As a Clinical Operations Manager, you are responsible and accountable for assigned protocols for budget/finance aspects, for execution and oversight of clinical trial submission and approvals in Switzerland and to ensure site ready.

The primary activities include but are not limited to:

- Executes and oversees clinical trial country submissions and approvals for assigned protocols.
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements.
- Oversees clinical research-related payments. Payment reconciliation at study close-out. Oversees financial compliance checks, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Oversees import activities for clinical trial supplies into Switzerland and maintains broker relationship.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs.
- Coordinates and liaises with CRM, CTC, CRA to ensure country deliverables are obtained for submissions, budgets, contracts and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
- Contribute or lead initiatives and projects adding value to the business.
- Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

Qualifications:

- Bachelor’s or Master's Degree in Life Science, Biology or equivalent. Education in business finance or administration would be advantageous.
- Minimum of 3-5 years’ experience in clinical research or clinical research + finance.
- Deep knowledge of the local regulatory environment, as well as scientific and clinical research knowledge is required.
- Excellent German and English communication skills (verbal and written), Italian and/or French would be an asset. Strong communication, leadership, and negotiation as well as excellent influencing and mentoring skills.
- Knowledge in budget and contract negotiation, submission and approval process.
- Strong coordination and organizational skills.
- Ability to make decisions independently with limited oversight from the manger. Proactively develop risk management and mitigations plans and resolve issues locally.
- Effective and efficient time management, organizational and interpersonal skills.
- High sense of accountability and urgency in order to properly prioritize deliverables, ability to focus on multiple deliverables and protocols simultaneously is essential.
- Ability to work effectively in office but also remote/virtual environment with a wide range of people.
- Positive mindset, growth mindset, being self-driven.

Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

**THE COMPANY**

Our company has had a presence in Switzerland since 1963. With a region

  • Clinical Operations Manager

    vor 1 Woche

    Luzern, Schweiz MSD Vollzeit

    In this position you are working for a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines. The company has longstanding commitment to prevent and treat diseases and invests significantly in research and development to address unmet public health needs with innovative treatment options. Our ability to excel...

  • Clinical Operations Manager

    vor 1 Woche

    Luzern, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Operations Director

    vor 1 Woche

    Luzern, Luzern, Schweiz Lindus Health Vollzeit

    Career OpportunityWe're excited to offer a career opportunity for an experienced Trial Manager to join our team at Lindus Health. As a key member of our Clinical Operations team, you'll be responsible for leading and managing the day-to-day running of CTIMP and non-CTIMP clinical trial programs and projects.You'll work closely with our tech and product teams...

  • Clinical Operations Specialist

    Vor 6 Tagen

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    Hobson Prior is a leading life sciences recruiter seeking a skilled Clinical Trial Scientist to join our client's team in Basel-Land.In this role, you will work closely with clinical trial physicians to support various trial activities.Main Responsibilities:Develop and maintain knowledge of relevant scientific literature.Prepare and review trial documents,...

  • Clinical Trial Coordinator

    vor 1 Woche

    Luzern, Luzern, Schweiz Lindus Health Vollzeit

    About UsLindus Health is a cutting-edge clinical trial infrastructure provider that aims to revolutionize the way new medicines are developed.">Job DescriptionWe're seeking an experienced Trial Manager to join our team and support the management and delivery of clinical trials to our clients in Germany and France. This role involves working closely with our...

  • Clinical Research Manager

    vor 2 Wochen

    Luzern, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Project Lead for Clinical Trials

    vor 1 Woche

    Luzern, Luzern, Schweiz Lindus Health Vollzeit

    OverviewLindus Health is a young company with a big impact, having already helped run over 100 clinical trials involving tens of thousands of patients. We're passionate about fixing the broken clinical trial infrastructure and making it faster, more reliable, and patient-friendly.">Job SummaryWe're looking for an experienced Trial Manager to join our team...

  • Senior Clinical Trials Manager

    Vor 2 Tagen

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    The Senior Clinical Trials Manager will play a key role in advancing clinical trials at Hobson Prior's Swiss office. As a seasoned professional in clinical trial management, you will be responsible for overseeing the submission process of clinical trial applications and ensuring seamless communication with health authorities.This position offers a unique...

  • Clinical Trial Coordinator Manager

    vor 1 Woche

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    Job Description:As a Clinical Trial Scientist, you will be responsible for supporting various trial activities and working closely with clinical trial physicians. This includes developing a strong understanding of the scientific and medical aspects of trials, ensuring all tasks comply with GCP standards.Key Responsibilities:Prepare and review trial documents...

  • Commercial Packaging and Clinical Trial Supplies Manager

    vor 2 Wochen

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    We are seeking an experienced and highly organized Clinical Trial Supply Manager to oversee the management and execution of clinical trial supplies from setup through to closeout. This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies, ensuring compliance with regulatory standards and...

  • Clinical Education Program Manager

    Vor 6 Tagen

    Luzern, Luzern, Schweiz B. Braun Medical AG Vollzeit

    Job DescriptionWe are seeking a highly skilled Clinical Education Program Manager to join our team at B. Braun Medical AG. In this role, you will be responsible for driving clinical marketing communication and training strategies to enable marketing and commercial teams to drive HCP awareness, guidance, and support.Key ResponsibilitiesTraining Strategy...

  • Clinical Supplies Coordinator

    vor 2 Wochen

    Luzern, Luzern, Schweiz MSD Switzerland Vollzeit

    **Clinical Supply Chain Management:**MSD Switzerland's Clinical Supplies Quality team manages the release of packaged and labeled drugs for clinical studies.**Key Tasks:**Review and approve incoming label stockRelease clinical finished goods after thorough reviewConduct GMP reviews of batch records and regulatory submissions**Essential...

  • (Sr.) Clinical Trial Coordinator

    vor 1 Woche

    Luzern, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Clinical Trial Coordinator

    vor 4 Wochen

    Luzern, Schweiz MSD Vollzeit

    **Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.** In this position you are working for a leading biopharmaceutical...

  • Clinical Trial Coordinator

    vor 4 Wochen

    Luzern, Schweiz MSD Vollzeit

    Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. In this position you are working for a leading biopharmaceutical company...

  • Trial Manager

    vor 1 Woche

    Luzern, Luzern, Schweiz Lindus Health Vollzeit

    LocationLucerneEmployment TypeFull timeLocation TypeRemoteDepartmentClinical OperationsOverviewApplicationOur missionAll new medicines need to undergo clinical trials to show they're safe and effective. But today's clinical trial infrastructure is stuck in the past, and the cost of developing new medicines has skyrocketed as a result. Patients have to wait...

  • Clinical Trial Application Expert

    Vor 2 Tagen

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    Hobson Prior is seeking a highly skilled Clinical Trial Application Expert to join their team in Allschwil, Switzerland. This role focuses on managing clinical trial applications and ensuring compliance with regulatory requirements.The successful candidate will be responsible for guiding clinical trials through submission processes and maintaining effective...

  • Research Scientist

    Vor 6 Tagen

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    Hobson Prior is a leading life sciences recruiter seeking a skilled Clinical Trial Scientist to join our client's team in Basel-Land. As a key member of the clinical trial physician team, you will work closely with physicians to support various trial activities.This role requires a strong understanding of scientific and medical aspects of trials, ensuring...

  • Trials Management Specialist

    vor 1 Woche

    Luzern, Luzern, Schweiz Lindus Health Vollzeit

    Clinical Operations RoleWe're seeking an experienced Trial Manager to join our Clinical Operations team and help us deliver successful clinical trials. As a key member of our team, you'll be responsible for leading and managing the day-to-day running of CTIMP and non-CTIMP clinical trial programs and projects.You'll work closely with our tech and product...

  • Medical Science Liaison

    Vor 6 Tagen

    Luzern, Luzern, Schweiz Pharmiweb Vollzeit

    We are seeking a skilled Clinical Trial Scientist to join our client's team in Basel-Land.This role requires a strong understanding of scientific and medical aspects of trials, ensuring all tasks comply with Good Clinical Practice (GCP) standards.Responsibilities:Collaborate with physicians on trial-related tasks.Develop and maintain knowledge of relevant...