Expert Clinical Trial Documentation - Clinical Trial Associate (CTA) — Octapharma
- Lieu
- Lachen
- Contrat
- full-time
- Publié
- Hier
Vue d’ensemble du poste
Become part of a vital chain and contribute to our common goal of making people’s lives better.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines.
We are a privately-owned company, where the warmth of family meets the scale of a global organisation.
- Become part of a vital chain and contribute to our common goal of making people’s lives better.
- Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines.
- Your main tasks and responsibilities
- Set up and maintain Trial Master Files (TMFs) and lnvestigator Site Files (ISFs) according to Octapharma SOPs
Responsabilités principales
- Your main tasks and responsibilities
- Set up and maintain Trial Master Files (TMFs) and lnvestigator Site Files (ISFs) according to Octapharma SOPs
- Support the Clinical Team in preparing clinical trial documents and documentation for regulatory submissions
- Track clinical trial documents such as insurance certificates, confidentiality agreements and study contracts throughout the trial lifecycle
- Maintain audit and inspection readiness through periodic review of TMF accuracy and completeness, quality control checks, and a unified TMF management approach.
- Support audits and inspection preparation and execution with regards to the TMF
- Act as a central contact for trial documentation, designated project communications, support ad hoc tasks
- Manage returning/archiving of TMF documents
- Assume Data Protection / Information Security Champion responsibilities Assists in development of SOPs
- Perform vendor evaluation and oversight for selected vendors Your expertise and ideal skill set
Processus de candidature
- Excellent command of Microsoft Office applications and Adobe Acrobat DC
- Able to prioritize workload with attention to details and within timelines
- Able to learn on the job and apply new knowledge to future challenges
- Able to manage multiple and various tasks with a positive and flexible attitude
- We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
- Please apply in English.
- Do you have any questions?
- Then get in touch with your contact person. Claudia Vignau Senior Expert Talent & Acquisition Octapharma AG Seidenstrasse 2, 8853 Lachen now Find similar jobs:
Contacts
- T: +41 55 451 21 35
- Want to find out more about us?
- Visit our website Octapharma Career and follow us daily on LinkedIn . About Octapharma
- Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
- We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care.
- With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US.
- With four decades of experience, we are committed to advancing patient care worldwide.
Entreprise et contexte
- Assist in the organization of lnvestigator Meetings
- Perform various administrative tasks to support team members with clinical trial execution, as required (e.g. literature search or document formatting review for regulatory submissions) In addition, for the senior position:
- Strong operational, organizational, documentation, communication, and interpersonal skills, able to work in a team and independently Your department - where you make an impact
- The Clinical Research and Development (CR&D) team in Lachen develops medicines that target complex and life-threatening conditions in Haematology and Critical Care
- We specialize in clinical development of new as well as already marketed products
- The successful candidate will work closely with CPMs, CTMs, and colleagues across CR&D in Lachen to support a wide variety of clinical trials
- This position reports to the Global Senior Director CR&D in Lachen and is a permanent role within the team.
- Work with skilled and fun colleagues in a relatively informal organization Skills development
- We offer various internal and external employee and leadership trainings, trainee programs and digital solutions It´s in our blood
- We live diversity and stand for equal opportunities as an employer!
Détails supplémentaires
- Perform various administrative tasks to support team members with clinical trial execution, as required (e.g. literature search or document formatting review for regulatory submissions) In addition, for the senior position:
- Assume Data Protection / Information Security Champion responsibilities Assists in development of SOPs
- Perform vendor evaluation and oversight for selected vendors Your expertise and ideal skill set
- Strong operational, organizational, documentation, communication, and interpersonal skills, able to work in a team and independently Your department - where you make an impact
- Cristina Solomon, Global Vice President CRD Lachen You help save lives
- Every day is meaningful as we produce life-saving medicines
- Work with skilled and fun colleagues in a relatively informal organization Skills development
- We offer various internal and external employee and leadership trainings, trainee programs and digital solutions
- Then get in touch with your contact person. Senior Expert Talent & Acquisition Seidenstrasse 2, 8853 Lachen
- Visit our website Octapharma Career and follow us daily on LinkedIn .
Notes et contenu original
- Perform various administrative tasks to support team members with clinical trial execution, as required (e.g. literature search or document formatting review for regulatory submissions)
- In addition, for the senior position:
- Assume Data Protection / Information Security Champion responsibilities
- Assists in development of SOPs
- Perform vendor evaluation and oversight for selected vendors
- Your expertise and ideal skill set
- Strong operational, organizational, documentation, communication, and interpersonal skills, able to work in a team and independently
- Your department - where you make an impact
- Cristina Solomon, Global Vice President CRD Lachen
- Thrive with us
Questions sur cette offre
Quel salaire propose Octapharma pour ce poste ?
Octapharma indique CHF 69 500 - 106 000 bruts par an pour ce poste à Lachen. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.
Est-ce un poste à temps plein, et quel type de contrat propose Octapharma ?
Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec Octapharma pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.
Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Schwytz ?
Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Schwytz peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Schwytz ou avec les RH pendant la candidature.
Comment postuler à ce poste chez Octapharma ?
Utilisez le bouton « Postuler maintenant » sur cette page — il renvoie directement à l'annonce originale de Octapharma sur careers.octapharma.com, votre candidature arrive donc directement dans le système de suivi des candidatures de l'employeur. Frontaliere Ticino ne collecte ni ne transmet lui-même les candidatures.
