Job Title: Clinical Operations Coordinator

Location: Basel, Switzerland, 2 days remote working

Duration: 12 months initial contract

Salary: CHF61 phr

CK QLS are recruiting for Clinical Operations Coordinator, to join a growing global pharmaceutical company, on a permanent role in Switzerland.

Clinical Operations Coordinator Role:
Assists the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct and until archiving, for an assigned trial.Coordinate the preparation and/or review of all operational trial-related documents (forms, guidelines).Coordinate the preparations and/or review of site related documents (Investigator Site Files- ISF).Coordinate the preparation and distribution of the clinical study documentation (site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report -CSR).
Further Responsibilities will Include:
Ensure completeness and maintenance of key trial information in the Clinical Trial Management System (CTMS).Ensure accurate maintenance and archiving of the electronic Master File (eTMF) within the required timelines and contribute by performing ongoing quality checks/review. Support the Clinical Trial Teams, including the Global Strategic Sourcing Group (Issuing of confidentiality agreements (CDAs), contracts execution and shipment, issuing of change orders, Resource Request management, coordination of the providers contracts, processing of invoices in the system).
Your Background:
Minimum 2 years of clinical research experience is preferred.Ability to effectively handle multiple priorities in a fast-paced environment.
Apply:

Please could you send any correspondence in English. Please quote job reference in all correspondence. It is essential that applicants hold entitlement to work in Switzerland.

Job Title: Global Trial Lead Contractor

Duration: 12 months

Location: Allschwil, Switzerland

Salary: Up to CHF110 phr

CK QLS are recruiting for a Global Trial Lead contractor, to join a global pharmaceutical company, on a contract basis in Allschwil, Switzerland.

Global Trial Lead Contractor Role:
Manage the operational trial related activities in close collaboration with other functions.Manage the selection of External Service Providers (ESP) in collaboration with other functions.Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
Further Responsibilities will Include:
Supervise the deliverables towards the Contract Research Organization (CRO) and External Service Providers (ESPs) selected for the trial, to ensure compliance with study protocol and in accordance with scope of work.Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators).Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review.
Your Background:
Bachelor of Science degree or equivalent University degree in life sciences or healthcare.10 years of experience in managing operational aspects of complex Phase II and Phase III clinical trials and global teams.At least 3 years of experience as a Sr COM or other equivalent position in previous working history.Previous involvement in high complexity trials, with ability to overcome challenges and impact study conduct.Ability to represent Clinical Operations in high level Clinical Development meetings.Intensive experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.Experience working with electronic data capture, electronic Trial Master File and Clinical Trial Management Systems.Excellent knowledge of ICH-GCP.
Apply:

Please could you send any correspondence in English. Please quote job reference in all correspondence. It is essential that applicants hold entitlement to work in Switzerland.

Job Title: Clinical Operations Manager

Location: Basel, Switzerland, 2 days remote working

Duration: 12 months initial contract

Salary: CHF170,000

CK QLS are recruiting for Clinical Operations Managers, to join a growing global pharmaceutical company, on a permanent role in Switzerland.

Clinical Operations Managers Role:
Driving the development of the operational trial related documents and procedures, as well as setting-up the service providers and supervising the deliverables of all service providers related activities, from specifications to close-out.Manage the operational trial related activities in close collaboration with other functions, such as site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance.Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
Further Responsibilities will Include:
Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits.Contribute to the Study Master File completeness and readiness for audit/inspection and by performing ongoing quality checks/review.Lead the development of trial-related operational document.
Your Background:
Bachelor of Science degree or equivalent University degree in life sciences or healthcare.4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report.Experience in selecting and managing External Service Providers.
Apply:

Please could you send any correspondence in English. Please quote job reference in all correspondence. It is essential that applicants hold entitlement to work in Switzerland.

Technician Clinical Packaging

Duration: 2 years

Start date: As soon as possible

Reporting to: Head Packaging Operations

CK QLS are looking for a Technical Packaging Operations, to join a global biopharmaceutical company, based in Lucerne for a duration of 2 years. The contract is likely to be extended.

Responsibilities:

Filling, labelling and packaging of clinical trials
Manual or semi-automatic filling of solid medicines (tablets, capsules) into primary packaging in accordance with internal guidelines, SOPs and packaging instructions.Manual or semi-automatic labelling and packaging of clinical drugs in accordance with internal guidelines, SOPs and packaging instructions.Works precisely in accordance with standard operating procedures (SOPs), batch regulations, internal company guidelines and the instructions of the responsible study managers.Operates machines and equipment for the provision of clinical trial material.
Documentation
Documents clinical packaging, logbooks, packaging-specific documentation and electronic batch documentation.Documents in accordance with internal documentation guidelines.Carries out SAP transactions and is responsible for the correct SAP handling of the assigned packaging operator.
GMP compliance
Adheres strictly to packaging instructions.Reports special incidents to the supervisor immediately.
Requirements:
Team-oriented.Enjoys working in a precise, structured and efficient manner.Enjoys working with technical equipment and machines.Fluency in German. English is an advantage, but not essential.IT skills (MS Office and SAP).
Apply:

It is essential that applicants hold entitlement to work in the Switzerland. Please quote job reference in all correspondence.