Senior Clinical Study Assistant

Vor 4 Tagen

Wien, Österreich Labcorp Vollzeit

The Senior Clinical Study Assistant (CSA) will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
- Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the FSP Manager.
- Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
- Perform departmental tasks as needed.

ACCOUNTABILITIES:

- Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
- Supporting/oversight of risk-based monitoring.
- Attendance of key team meetings as required; may make presentations (e.g. data, etc.).
- Supporting regulatory inspection readiness (e.g. preparation of materials and/or participation during regulatory inspections.)
- Support clinical trial systems (e.g. CTMS/TMF/COMPASS(?) associated activities for selected studies
- Supporting vendor contract administration as required.
- Support study close-out activities, e.g. financial reconcilliation - Supporting additional ad-hoc activities as needed, as agreed with Manager(s).

Provide support for departmental tasks, including but not limited to:

- Maintaining knowledge of systems and processes.
- Attending internal and external trainings as needed and maintaining up-to-date training record.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

- Bachelor’s degree or equivalent international degree required.
- 2-4 years’ experience in pharmaceutical industry, clinical research organization, or related role.
- Experience in Phase 2 and 3 studies and global/international studies is advantageous.
- Experience working across multiple therapeutic areas (including oncology) is advantageous.
- Knowledge in global/regional regulatory and compliance requirements for clinical research.
- Demonstrated excellence in task management and cross-functional collaboration.
- Excellent communication skills.
- Excellent teamwork, organizational, interpersonal, and problem-solving skills.
- Fluent business English (oral and written).

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

  • Study Coordinator in Vienna

    vor 4 Wochen

    Wien, Österreich WCG Frankurt GmbH Vollzeit

    Are you motivated and result driven, open for new challenges and looking for an exciting, professional and satisfying work environment with providing services that effectively attract, engage and observe patients throughout the entire clinical study? If so, this may be the opportunity for you to develop your clinical and research skills and join WCG...

  • Study Contracts Manger

    vor 4 Wochen

    Wien, Österreich AstraZeneca Vollzeit

    **Study Contracts Manger - Clinical Trials (Site Management & Monitoring)** **Location: Austria - Vienna** **Competitive salary and benefits** **Hybrid working 3 days a week int he office** Astra Zeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription...

  • Clinical Study Manager

    vor 2 Wochen

    Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health. Together, we are a global Company which is...

  • Senior Clinical Project Lead

    vor 2 Wochen

    Wien, Österreich Proclinical Vollzeit

    I am partnered with a rapidly growing medical device company who are looking for a Senior Clinical Project Lead. As the key leader in our clinical affairs group, you will play a crucial role in the development, execution, and success of a ground-breaking class II-III devices. This is a home-based position which will initially be a contract position with the...

  • Eu - Clinical Project Manager (Cpm)

    Vor 6 Tagen

    Wien, Österreich Celerion Vollzeit

    One of our key assets and greatest resources is the experience and expertise of our employees. **We are looking for a (Senior) Clinical Project Manager (M/F)** **in Vienna, Austria** The main aim of the (Senior) Clinical Project Manager (CPM) is the operational management of studies or projects managed by Celerion. **Essential Functions** - Perform...

  • Senior Clinical Strategy Manager

    vor 2 Wochen

    Wien, Österreich Valneva Vollzeit

    Execution of clinical development programs (currently especially Covid-19) - Provision of strategic development input and input to clinical development plans - Writing of individual study protocols - Drive data analysis and interpretation of clinical trials - Participation in the development of clinical study documents - Support of interactions with...

  • Clinical Study Manager

    vor 4 Wochen

    Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health. Together, we are a global Company which...

  • Clinical Study Manager

    vor 10 Stunden

    Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health. Together, we are a global Company which...

  • (Senior) Clinical Project Manager

    vor 1 Woche

    Wien, Österreich PSI CRO Vollzeit

    Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Take your career to the next level and...

  • (Senior/principal) Clinical Team Manager

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Hematology and Oncology** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to...

  • Senior Clinical Research Associate

    vor 4 Wochen

    Wien, Österreich Proclinical Vollzeit

    Proclinical Staffing are partnered with an established CRO currently looking for an individual to join their team. This role is on a permanent basis located in Austria. The opening position is for an Experienced Clinical Research Associate. **Responsibilities**: - Work alongside and mediate with study team members for project implementation assistance when...

  • Clinical Strategy Manager

    vor 4 Wochen

    Wien, Österreich Valneva Vollzeit

    Develop clinical study documents and take over individual clinical study tasks - Medical writing for clinical and regulatory documents - Perform clinical study data analysis and interpretation of clinical trials - Organize advisory boards and study committees (Scientific Advisory Boards, DSMBs, Endpoint Adjudication Committees, etc.) - Conduct and summarize...

  • (Senior/principal) Clinical Team Manager

    vor 2 Wochen

    Wien, Österreich PPD Vollzeit

    **(Senior/Principal) Clinical Team Manager - Infectious and Respiratory Diseases** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources...

  • (Senior/principal) Clinical Team Manager

    Vor 2 Tagen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Cardio,Metabolic and Critical Care** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD Clinical Research Services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a...

  • (Senior/principal) Clinical Team Manager

    Vor 2 Tagen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Hematology and Oncology** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD Clinical Research Services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly...

  • (Senior/principal) Clinical Team Manager

    Vor 2 Tagen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Neuroscience** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD Clinical Research Services— thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and...

  • (Senior/principal) Clinical Team Manager

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Neuroscience** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • (Senior/principal) Clinical Team Manager

    vor 2 Wochen

    Wien, Österreich PPD Vollzeit

    **JOB DESCRIPTION**: **(Senior/Principal) Clinical Team Manager - Infectious and Respiratory Diseases** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our...

  • Study Start-up Associate

    vor 4 Wochen

    Wien, Österreich Labcorp Vollzeit

    Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers! If you are looking to take on responsibility and leverage your...

  • Clinical Scientist

    vor 4 Wochen

    Wien, Österreich Hookipa Pharma Vollzeit

    **About HOOKIPA**: HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are...