Senior Clinical Research Associate
- Strong time management, organizational, and communication skills.
- Strong organization and interpersonal skills, ability to communicate effectively internally and externally. Maturity to support junior colleagues in their professional development. Ability to influence others, diplomacy, and negotiation skills.
- Computer skills including proficiency in Microsoft Office suite: Word, Excel, and PowerPoint.
- Able and willing to travel and work remotely at least 50% of the time.
- Have a full understanding of Serious Adverse Event (SAE) reporting, narratives, and follow-up of SAEs. Good knowledge of international standards (ICH-GCP/ISO, FDA, EMEA). Positive and energetic attitude, customer service oriented. Willing to take initiative in a dynamic environment. Ability to work independently and as a team member. Hands-on “Startup mentality” is a prerequisite.
- Master’s or Bachelor’s Degree Required, preferably in a scientific or healthcare discipline. Therapeutic knowledge is a plus.
- A minimum of 5 years clinical trial experience of which at least 3 years as a CRA, preferably within a CRO, medical device, or pharmaceutical company.
- Fluent in English (oral, written) plus at least 1 Swiss national language (German, French, Italian). Additional languages are a plus.
The CRA will be responsible for managing and tracking the progress of clinical studies at Hemex. Functional responsibilities will include:
- Manage assigned study sites and multicenter, multinational clinical trials, conduct phase I-IV trials according to protocol.
- Ensure that Essential Documents are available for filing in the electronic Trial Master File (eTMF). Verify that the Investigator’s Site File (ISF) is maintained in accordance with ICH-GCP/ISO 14155 and local regulatory requirements.
- Literature and clinical database review to assess feasibility and study design. Screen potential investigators to evaluate capabilities for conducting clinical trials.
- Conduct and manage monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned; (i.e., study start-up, recruitment, database analyses, closeout, etc.).
- Conduct site visits (selection visits, initiation visits, monitoring visits, close-out visits) and write reports to ensure compliance with the protocol, ICH-GCP/ISO 14155, global and local regulations, global and local processes to secure data integrity and patient safety.
- Ensure that site personnel is fully trained on all trial-related aspects during Site Initiation Visits (SIV).
- Independently manage training and support requests from clinical trial sites.
- Proactively identify quality issues at sites; resolve issues and escalate as appropriate.
- Support the start-up phase of assigned studies by tracking regulatory submissions and approvals.
- Manage and maintain information and documentation by updating all electronic systems (eTMF, eCTMS) to track clinical trial progress, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Manage organization of audits and assure inspection readiness activities for monitoring and site-related activities; ensure implementation of corrective actions (CAPA) within specified timelines.
- Responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations, and SOPs.
- Support CTM with the efficient conduct of the trial according to timelines and budget. Provide guidance and regular training to CTA and CRA I.
People Management responsibilities:
- Collaborate with the Clinical Operations team through different stages of a clinical study.
- Manage the Sponsor team and Site Staff throughout the assignment.
- Be (financial) results-oriented for Hemex and its clients.
- Join a small team of multinational, multidisciplinary, highly motivated experts.
- Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
- Ability to independently manage your role and responsibilities.
- Opportunity to develop yourself and support start-ups developing highly innovative therapies.
- Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.
Bilingual Executive Assistant (Opterion)
Opterion Health, a Swiss-based life sciences company, is currently looking for a bilingual (English/German) Executive Assistant to be the supportive force that empowers our leadership team. The ideal person for the job will be a proactive problem solver with excellent communication skills and a meticulous attention to detail. She/he will have experience working in an office environment, performing administrative duties and providing support to the executive team. The position (60% – 80%) is based in Muttenz with the possibility of working from home one day.
Skills & Qualifications:
- Degree in Commercial or equivalent qualification
- At least 3 years’ experience as an Executive Assistant or in an administrative role
- Excellent written and verbal communication skills in English and German
- Experience in the Pharmaceutical or Life Sciences industry
- Strong time-management skills and the ability to organize and coordinate multiple projects simultaneously
- Proficiency in Microsoft Office and other office productivity tools, with ability to learn new software and systems
- Flexible team player willing to do what it takes to get the job done; independent, adaptable and enjoys a challenge
- Ability to keep company confidences
- Supporting the Management team in day-to-day business
- Planning and orchestrating work to ensure the management’s priorities are met, organizational goals are achieved, and best practices are upheld (e.g., manage agenda, organize meetings and take meeting minutes)
- Arranging travel and travel-related activities
- Organizing meetings with Board of Directors, Shareholders, Scientific Advisory Board, Investors and other external parties
- Coordinating the flow of contractual documents (track of changes, signatures; using DocuSign and other electronic tools) and filing (electronic and physical)
- Assisting with presentations and other material
- Perform administrative and office support, such as invoicing, accounting and preparing presentations
- Supporting Project Management and Quality Management System
- Organizing team communication and planning events, both internally and offsite
- Maintaining professionalism and strict confidentiality with all materials and exercising discretion in dealing with the company
- Efficient management of the office in Muttenz
- Permanent contract starting ASAP
- Competitive salary
- Flexible working arrangements