Clinical Project Manager, 100%

LimmaTech Biologics AG; Zürich; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

LimmaTech Biologics AG in Switzerland is seeking a Clinical Project Manager (100%) to lead and manage clinical trials and programs, including Phase I/II studies. The role focuses on scope, quality, timeline and budget adherence, with emphasis on high-quality study documentation and regulatory submissions.

You will coordinate CROs, sites, and vendors, plan visits and trainings, and ensure data integrity and accurate reporting, while driving risk mitigation and development plans in a fast-paced,

Qualifikationen

• Master’s or PhD in Life Sciences and 5+ years in clinical operations.
• Led and managed clinical trials or programs, ideally Phase I/II.
• Experience in selection and management of CROs, sites, vendors and consultants.
• Strong planning, communication and regulatory submission experience.

Aufgaben

• Manage clinical trials to ensure adherence to scope, quality, budget and timelines.
• Prepare high quality clinical study documentation (protocols, study plans, reports, ICFs, manuals).
• Identify risks, assess impact, and drive mitigation strategies.
• Plan and conduct site initiation visits, monitoring visits, investigator meetings, trainings and KOL interactions.
• Manage regulatory submissions per requirements and timelines.
• Conduct data reviews and resolve data queries; support data integrity activities.
• Oversee CROs, sites, vendors and consultants to ensure performance.
• Manage trial budgets and negotiate contracts for cost efficiency.
• Shape development plans and regulatory strategies to achieve program objectives.
• Ensure compliance with ICH-GCP and local regulations; update SOPs.

Kenntnisse

Hands-on clinical trial management

Planning & communication

ICH-GCP familiarity

English communication

Ausbildung

Master’s or PhD in Life Sciences

Jobbeschreibung

LimmaTech Biologics AG is a Swiss clinical stage biopharmaceutical company. We are advancing our vaccine pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance (AMR) and sexually transmitted diseases. Working at LimmaTech is a unique chance to be part of the development of life saving vaccines.

To support our Clinical team, we are currently looking for a:

Clinical Project Manager, 100%

You have a Master’s or PhD degree in Life Sciences and at least five years of experience in clinical operations, preferably within the pharmaceutical or biotechnology industry, where you have successfully led and managed clinical trials or programs, ideally in Phase I and II studies.

As a member of the Clinical team your responsibilities will include:

• Managing clinical trials to ensure adherence to scope, quality, budget and timelines
• Preparation of high quality clinical study documentation (including but not limited to protocol, study plans, reports, informed consent forms, and clinical manuals)
• Proactively identifying risks, assessing impact, and driving effective mitigation strategies
• Planning and conducting site initiation visits, monitoring visits, investigator meetings, training sessions, and key opinion leader interactions
• Managing and preparing ethical and regulatory submissions in accordance with applicable requirements and agreed timelines
• Conducting data reviews, resolving data queries, and supporting database quality and integrity activities
• Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc. to ensure performance and deliverables
• Managing clinical trial budgets and negotiating contracts to ensure cost efficient execution
• Shaping and implementing clinical development plans and regulatory strategies to achieve program objectives
• Working in accordance with ICH-GCP (E6(R3)), applicable local regulations, and company SOPs
• Presenting clinical data internally and externally
• Authoring, revising and/or updating SOPs, Work Instructions and other relevant documents
• Supporting general activities of the clinical department and representing it on cross-functional teams, with management or key stakeholders as needed

You are a proactive, and enthusiastic team player, motivated to bring tasks to completion with:

• Hands-on experience in successfully managing all operational aspects of clinical trials
• Experience in the development of study-related documents, including study protocols, study reports, informed consent forms, and clinical study plans
• Experience in selection and management of CROs, clinical sites, vendors and consultants
• Excellent planning and communication skills
• Good understanding/previous experience in the submission of clinical trial application packages and communication with ECs, IRBs, and regulatory authorities such as the EMA and FDA
• In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans
• A desire to work successfully in an entrepreneurial, innovative, fast-paced environment, where science-based outcomes matter
• Good verbal and written communication skills in English

We offer a friendly, highly motivated, multi-cultural, and dynamic work environment located in Schlieren, near Zürich. The location is easily accessible by public transportation.

Please note that due to visa regulations, only applicants eligible to work in Switzerland can be considered for this position.

Please note that applications for this position are processed in collaboration with an external recruitment service provider. By submitting your application, you acknowledge that your CV and related application documents may be shared with such service provider solely for the purpose of supporting the recruitment and selection process for this role.