Clinical Research Associate

vor 9 Stunden

Home Office, Schweiz Syneos Health Clinical Vollzeit

**Description**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
- For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:

- Site support throughout the study lifecycle from site identification through close-out
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff
- The SMA II may be requested to train junior staff
- Ide

  • Clinical Research Associate

    vor 1 Tag

    Home Office, Schweiz ICON Vollzeit

    As a Clinical Reasreach Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Role: If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. ICON...

  • Clinical Research Associate 2

    vor 1 Woche

    Home Office, Schweiz ICON Vollzeit

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Development, Associate Director Innovative

    vor 1 Tag

    Home Office, Schweiz Hengrui Europe Therapeutics AG Vollzeit

    **Job Title**: Clinical Development Associate Director Innovative Medicines **Reports to**: Sr. Medical Director for Innovative Medicines **Department**: Innovative Medicines, Clinical Development **Location**: Basel, Switzerland OR Spain, OR Poland OR Netherlands **Direct reports**: No Responsible for the management of assigned trials from clinical for...

  • Associate Clinical Supply Chain Manager

    vor 1 Woche

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    **Associate Clinical Supply Chain Manager - Ancillaries** **EMEA - Remote** When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to...

  • Clinical Research Associate

    Vor 5 Tagen

    Home Office, Schweiz IQVIA Vollzeit

    We are currently hiring a **CRA (M/F/d) **to work in our multi-sponsor department and to join our team in a home-based position in Switzerland. Beside establishing strong relationships with our clients and the involved investigators, you will conduct monitoring on complex clinical trials and assure the adherence to good clinical practices, standard...

  • Manager, Clinical Operations

    Vor 2 Tagen

    Home Office, Schweiz ICON Vollzeit

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Research Associate for Study Start Up

    Vor 2 Tagen

    Home Office, Schweiz ICON Vollzeit

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Global Clinical Trial Assistant

    Vor 2 Tagen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Global Clinical Trial Assistant - Managed Access Programs** **Home based in Belgium, Italy, Germany, Switzerland, Spain, Netherlands or Portugal** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...

  • Director, Clinical Affairs

    vor 9 Stunden

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    The mission of the Clinical Affairs group within Medical and Scientific Affairs is to create value for ImmunoDiagnostic Division (IDD) by providing clinical evidence for product pre-launch or post-launch across the portfolio. Main responsibilities for the unit are: - Own IDD clinical affairs planning, execution and reporting - Develop timely and...

  • Freelance Cra for 20-30% Work, Fsp, Home-based

    Vor 3 Tagen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Freelance Sr CRA, home-based, FSP, client dedicated, Switzerland** For this role we are looking for a (Sr)CRA Freelancer 0.2 FTE with potential increase to 0.3 FTE for July/August plus 1 month of training beforehand. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer...

  • Cra (All Levels), Hybrid, Fsp Client-dedicated

    Vor 3 Tagen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **CRA (II or Sr CRA I), home-based, FSP client-dedicated, Switzerland - full-time, permanent role** We are looking for a team member to join our FSP team as CRA, dedicated to one big global pharma. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with...

  • Associate Project Director

    vor 1 Woche

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Associate Project Director (Project Lead) - Oncology / General Medicine **open to any EMEA country** Come discover what our 25,000+ employees across 110 countries already know: **work here matters everywhere**. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer...

  • Associate Director, Global Clinical Process

    Vor 3 Tagen

    Home Office, Schweiz BeiGene Vollzeit

    General Description: The Global Clinical Process Management Lead will champion the investigation, development and implementation of process management activities for Global Clinical Operations; Working collaboratively with relevant GCO team members globally, to ensure BeiGene GCO standards and processes are efficient, optimized and maintained in compliance...

  • Global Clinical Compliance Lead

    vor 9 Stunden

    Home Office, Schweiz BeiGene Vollzeit

    General Description: - The Global Clinical Compliance Lead (gCCL) is responsible for implementing the global clinical compliance and inspection management strategy across BeiGene clinical programs at study level, as assigned. The gCCL provides compliance and quality support to BeiGene GCO study teams for the assigned programs / studies and ensures that...

  • Team Leader, Clinical Supply Chain Emea Remote

    vor 1 Tag

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    Business Job Title: Team Leader Clinical Supplies Optimization Services Job Profile Title: (Internal title) Manager, Supply Chain Projects Direct Report To: Therapeutic Area Manager Group/ Division: Pharmaceutical Services Group/CTD Career Band: 7 Career Track: Management Position Location: Horsham, UK / Remote Number of Direct Reports: 5-10 When...

  • Sr Project Manager

    vor 1 Woche

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Senior Project Manager** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

  • Sr Project Manager

    vor 1 Woche

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Sr Project Manager (Project Lead) - Oncology **open to any EMEA country** Come discover what our 25,000+ employees already know: **work here matters everywhere**. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career...

  • Clinical Trial Assistant

    Vor 2 Tagen

    Home Office, Schweiz ICON Vollzeit

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Project Manager

    vor 1 Tag

    Home Office, Schweiz IQVIA Vollzeit

    Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...

  • Svp, Business Development, Fsp Europe

    Vor 7 Tagen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **SVP, Business Development** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health...