Project Manager in Clinical Pharmacology
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Project Manager in Clinical Pharmacology for a 12 months contract based in Basel area.
The ideal candidate should have from 2 to 5 years of previous experience providing operational leadership for assigned Phase I/IIa studies. In addition, budget negotiation experience is desirable.
- Provide operational leadership for assigned Phase I/IIa studies by being responsible for the operational deliverables, milestones, data quality, and deadlines related to assigned clinical studies from study start to Trial Master File (TMF) archiving;
- Proactively manage changes in the planning and conduct of assigned studies, identify potential issues, and devise contingency plans;
- Selection and management of External Service Providers (ESP);
- Responsible for the finalization of selected ESP contract, budget negotiation for assigned studies, and for the accurate and timely processing of ESP invoices;
- Acts as a central point of contact, lead, and manage the communication between the study team and all stakeholders to support the implementation of assigned studies;
- Make clinical supplies projections in collaboration with Pharmaceutical Development-Clinical Trial Supply;
- Responsible for the timely operational input in the review and delivery of study-related documents;
- Lead the collection, review, and finalization of documents required for Independent Ethics Committee (IEC)/Institutional Review Board (IRB) and Health Authorities submissions;
- Responsible for ensuring that all essential documents required for Investigational Medicinal Product (IMPs) shipment of assigned studies are in place prior to shipment;
- Provide direction and support to monitoring activities of assigned studies by authoring the Study-Specific Monitoring Plan and coordinate/participate in the monitoring as needed;
- Responsible for inspection readiness, completeness, and quality of assigned studies' TMF from study start to archiving;
- Follow relevant quality control procedures to ensure the quality requirements for the study-related activities are fulfilled.
Qualifications and Experience:
- Post-graduate degree in life sciences degree or equivalent;
- Early phase project management experience is desirable;
- Agreement and Budget negotiation experience/awareness is also desirable;
- Demonstrated ability to work in teams in a fast-paced environment, to prioritize multiple competing tasks, and to proactively address issues and demands;
- Proven record of successfully interacting with different stakeholders, implementing solutions and negotiating contracts;
- Ability to communicate effectively in English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.