An excellent opportunity has arisen to join a leading pharmaceutical company as a Project Manager in Clinical Pharmacology.
*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
*Provide guidance and mentoring to less experienced colleagues within the team
*Post-graduate degree in life sciences degree or equivalent
*Early phase project management experience is desirable
*Knowledge of practical applications of ICH-GCP, and of regulatory documents for the conduct of clinical studies
*Agreement and Budget negotiation experience/awareness is also desirable
*Good organizational and problem-solving skills with the ability to work in a matrix environment
*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 with internal and external stakeholders in fluent written and spoken English
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: firstname.lastname@example.org
Tel: +41 4350 86620 or email: email@example.com
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