Our client is a biopharmaceutical clinical-stage company leading the development and the engineering of cell therapies to treat cancers. Their activities cover Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics. The company is clinically active across Europe and the U.S. and offers the opportunity to interact with colleagues and stakeholders across the globe involved at each step of the product development process.
Review or Write Study documents: Protocol, Case Report Form, Informed consent form...
Select and activate chosen study sites
Establish and maintain an excellent relationship with site investigators and research teams
Develop and maintain study timelines
Development and/or review of external and internal Study documents and Plans, ensuring completeness and necessary updates in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Clinical Monitoring Plans, Project Plans)
Create and update activities in overall project plan regularly to ensure appropriate outcome of assigned clinical studies in terms of scope, timelines and objectives.
Set-up Study tracking and reporting tools
Ensure ongoing update of tracking and reporting tools
Coordination with other departments: Regulatory Affairs, Manufacturing, Medical experts, Pharmacovigilance …
Lead of the Clinical Study Team meetings
Participate to selection and provide oversight to all vendors, ensuring timely delivery of milestones and within budget
Responsible for ensuring vendors deliver according to scope of work and review/approve vendor invoices
Overall Budget Management, including Invoicing follow-up
Oversight activities of assigned CRA(s): monitoring activities, including report review. Support and guide CRA(s) site management activities.
Ensure study quality/GCP compliance to deliver a rigorous patient data
Liaise with manufacturing, central lab, and other study project stakeholders as needed
Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs
Qualifications & Experience
Degree in Life Science, biological science, or related area: B.S or equivalent relevant experience
Minimum 5 years’ experience in Clinical development in Biopharma industry (sponsor and/or CRO)
3-5 years’ experience in clinical study management in early phase oncology, prior small start-up company experience in biotechnology highly desirable
Strong knowledge of ICH and GCP rules and of the complete clinical trials process
Skills & Competencies
Creative and finding ways to get the job done. Thriving in challenging environments and finds ways to remove obstacles to complete enrollment and deliver a robust patient data package
Flexible mindset capable to manage change and deal with ambiguity.
Proven ability to manage complex projects. Flexibility to re-prioritize workload to meet changing timelines, adaptability.
Excellent communicator able to raise the profile of clinical studies within sites and create advocates for recruitment.
Autonomous, pro-active personality. Driven to achieving highest results in shortest timeframe.
Efficient in planning and executing work: orchestrate multiple activities at once.
Team player, able to manage matrix organization in multi-cultural environment.
The opportunity to join a fast-moving company with ambitious challenges combined with an intersting salary package.
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