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: email@example.com
Tel: +41 4350 86620 or email: firstname.lastname@example.org
Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years.
-We achieve results faster
-Our candidates really are a cut above
-We add greater value
We think it's because we're a private company driven by clients, not by shareholders.
For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.