Expert Clinical Trial Documentation - Clinical Trial Associate (CTA)

The position of Expert Clinical Trial Documentation, Clinical Trial Associate (CTA) is offered by Octapharma, a privately‑owned global leader in the production of human‑derived proteins for therapeutic use. Based in Lachen, Switzerland, the company creates medicines from plasma and cell‑line sources and operates a worldwide network of research, manufacturing and donation sites. In this role you will create and keep up‑to‑date the Trial Master Files and Investigator Site Files in line with Octapharma's internal procedures. You will aid the clinical team in assembling the paperwork required for regulatory filings, monitor the flow of items such as insurance certificates, confidentiality agreements and study contracts throughout each study, and ensure the documentation set remains ready for audits by performing regular quality checks. Additional duties involve acting as the main point of contact for trial‑related documents, handling ad‑hoc requests, organising investigator meetings, and supporting various administrative tasks like literature searches or formatting reviews. Senior‑level incumbents also take on data‑protection responsibilities, help draft SOPs and oversee selected vendors. The essential qualifications include at least one year of experience as a CTA or documentation specialist on international clinical trials (three years for the senior tier), fluency in written and spoken English, and familiarity with a range of CTMS and TMF platforms. Proficiency with Microsoft Office applications and Adobe Acrobat DC is required, as is the capacity to prioritise work with meticulous attention to detail, meet deadlines, and juggle several assignments while maintaining a positive, adaptable attitude. Strong organisational, communication and interpersonal abilities are also mandatory, enabling effective teamwork as well as independent execution. Preferred attributes comprise German language skills, extended experience for senior positions, and a willingness to act as a data‑protection champion, contribute to SOP creation and conduct vendor assessments. The role sits within the Clinical Research and Development (CR&D) unit that focuses on therapies for haematology and critical‑care conditions. You will collaborate closely with project managers, clinical trial managers and other CR&D colleagues, reporting to the Global Senior Director CR&D. Octapharma promotes a family‑oriented culture, offers a market‑aligned remuneration package, and provides extensive training and development opportunities in an informal, diverse environment. What the role asks for: - Minimum 1 year CTA/documentation experience in international trials - Fluent written and spoken English - Experience with CTMS and TMF platforms - Proficient in Microsoft Office suite - Proficient in Adobe Acrobat DC - Strong attention to detail and workload prioritisation - Ability to handle multiple tasks with flexibility - Strong organisational and communication skills - German language proficiency (preferred) - 3 years experience for senior position - Data‑Protection/Information‑Security champion duties (senior) - SOP development support (senior) - Vendor evaluation and oversight experience (senior)