CRM Manager Coffee Brands

Delica AG; Birsfelden; Vor Ort; CHF 100.000 - 150.000; Vollzeit

Zusammenfassung

Alentis Therapeutics, the Claudin-1 Company, is seeking a Clinical Supply Manager based in Allschwil near Basel to lead end-to-end trial supply activities for global clinical trials. In this role you will forecast demand, manage packaging, labeling, distribution, vendor relations, and QA coordination with GMP/GCP teams to ensure on-time delivery and compliance.

Candidates should have 3–5 years in clinical supply/logistics, strong project leadership, and experience with IRT/EDC systems (e.g.,

Qualifikationen

• 3–5 years of experience in supply chain/logistics in clinical trials.
• Extensive experience in project management and leadership in Clinical Supply Management.
• GMP/GCP regulations knowledge.
• Experience with IRT and EDC systems (e.g. Medidata).

Aufgaben

• Lead global trial supply planning and distribution.
• Coordinate packaging, labeling, and vendor management.
• Ensure QA and regulatory compliance for IMP shipments.
• Monitor inventory, expiry, and recalls.
• Collaborate with CMC, QA, and clinical sites.

Kenntnisse

Supply chain

Logistics

Clinical trials

Project management

Leadership

GMP/GCP

IRT/EDC

Medidata

Tools

Medidata

Jobbeschreibung

Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis.To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies.O...

Descartes Unites the People and Technology that Move the World.The need for efficient, secure, and agile supply chains and logistics operations has become ever more critical and complex.By combinin...

Shape the future of diagnostics – join our leadership team!.BÜHLMANN Laboratories AG is an internationally active and growing life sciences company headquartered in Schönenbuch, near Basel, Switzer...

Product positioning & audience ownership:.Apply and refine product positioning within established portfolio frameworks, ensuring clarity and resonance for assigned product audiences.Apply and refin...

Client Acquisition & Relationship Management.Own and manage a portfolio of partnership prospects based in your assigned region.Identify and build relationships with brands whose values align with A...

We are an employee owned, international project delivery firm with a team of 4.We are world leaders in the pharma, food, medtech and mission critical sectors.From our network of offices in Europe, ...

Swiss AviationSoftware is a 100% subsidiary of Lufthansa Technik, and along with our partners in the Digital Tech Ops Ecosystem, leads the digital transformation of the aviation industry in technic...

Location: San José, Costa Rica.This role is based at our San José Shared Service Center, where you will partner closely with business leaders to shape people strategies that support operational exc...

Take on a key leadership role in delivering complex projects for the pharmaceutical and biotechnology industries.As an Engineering Manager, you will be responsible for the technical execution of pr...

Viking (NYSE: VIK) was founded in 1997 and provides destination-focused journeys on rivers, oceans and lakes around the world.Designed for curious travelers with interests in science, history, cult...

French-Speaking Switzerland | GMP | Quality & Compliance.Looking for more visibility, responsibility and impact in Quality?.Join a specialized sterile pharmaceutical manufacturing site where y...

Manager & Senior Manager in Life Sciences Quality Management Consulting.Help sell, lead and, together with the team, deliver high-impact projects engaging with senior stakeholders from high-profile...

Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis.

Tasks

The Clinical Supply Manager is accountable for management, coordination and efficient on-time delivery of trial supplies (including IMP= Investigational Medicinal Product, Placebo, Standard of Care and clinical ancillaries) for global clinical trials to enable the fulfillment of company milestones.

IMP and ancillary supply management:

• Develop demand forecasts and supply plans based on study protocols, clinical scenarios and enrollment projections.
• Plan, implement and execute the supply strategy for trial medication and ancillary supplies in collaboration with clinical and CMC teams.
• Manage Standard of Care and ancillary supply purchase activities for clinical trials, if applicable.
• Oversee packaging design and lead blinding setup, if applicable.
• Develop and implement global distribution strategies, including depot selection.
• Manage trial medication inventory, expiry dates and anticipate re-supply needs in collaboration with CMC.
• Conduct user acceptance testing (UAT) of IRT/EDC systems and ensure alignment with study requirements.
• Manage IRT systems for supply management and inventory tracking.
• Act as main contact for labelling and packaging vendors and with clinical sites for topics related to trial supplies.
• Review and provide inputs on clinical documentation (e.g. Clinical monitoring plan).
• Prepare a request for proposal and lead vendor selection process, if applicable.
• Manage verbal (regular TC) and written (email) communication with external vendors to ensure project timelines.
• Clearly communicate the deadline for various activities / delivery to the vendors.
• Supervise outsourced labelling/packaging and distribution operations.
• Monitor the performance of the external vendors towards their respective delivery and initiate improvement/mitigation plans as necessary.
• Prepare and approve, in accordance with the related SOP, the Master Label Text according to relevant regulation.
• Coordinate the translations, review and approval of Local Label Texts.
• Review and approve labelling/packaging records and trial specific document in accordance with the related SOP.
• Monitor drug reconciliation, recall (with collaboration of QA), quarantine, return and destruction of IMP.
• Monitor import/export operations on IMP and ancillary supply until delivery at site.
• Report progress and project updates to the line manager on regular basis via email or regular TC.

Documentation management:

• According to the trial design, request (as appropriate), review and coordinate approval of external vendor quotes.
• File and archive trial specific document in Trial Master File.
• Draft and approve Pharmacy Manual.

Quality:

• In collaboration with GMP / GCP QA and CMC teams, lead the evaluation of deviations which will occur during the storage and/or transfer of the supplies to the clinical sites and archive records as per internal SOP.
• In collaboration with CMC team, manage the extension of the expiry dates of IMP according to the ongoing stability studies.
• Create, review and update Clinical supply-related SOPs.

Finance:

• Review and approve external vendor invoices.
• Support budget planning and cost control for clinical supply activities.

Requirements

• 3-5 years of experience in Supply chain/Logistics activities in clinical trials.
• Extensive experience in project management and leadership in Clinical Supply Management.
• Knowledge and understanding of GMP and GCP regulations as well as other company related regulatory requirements.
• Experience with IRT and EDC systems (e.g. Medidata)Ability to manage multiple studies simultaneously in a fast-paced biotech environment.

We offer a competitive salary and opportunities for career growth and development.

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The work location is Allschwil, Switzerland with 2 days home office possibility.

Alentis is the leading biotech company developing anti-Claudin-1 therapies. Claudin-1 is an extraordinary target that plays a key role in many solid tumors and fibrosis. We are committed to unlocking the broad potential of Claudin-1 and bringing much-needed new medicines to patients.