Our clients are startups and SMEs that are regularly looking for QA Engineers. They usually are companies that focus on the development of innovative solutions such as medical devices to treat headache disorders, or systems to treat severe cardiac diseases, for instance.
Are you interested in helping to shape a young and dynamic company? Would you like to participate in the development of innovative solutions in BioTech? Bringing your expertise in leading clinical projects is what you are looking for?
Plus One can offer this great opportunity! You will take part in all activities for clinical studies from protocol synopsis to clinical study report.
In this kind of exiting role as Clinical trial manager, you might be responsible for the following:
Review or Write Studydocuments: Protocol, Case Report Form, Informed consent form...
Select and activate chosen study sites
Establish and maintain an excellentrelationship with site investigators and research teams
Develop and maintain studytimelines
Development and/or review of external and internal Studydocuments 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 …
Participate to 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
Master or PhD degree in Life Science, biological science, or related area
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, prior small start-up company experience in biotechnology highly desirable
Strong knowledge of ICH and GCP rules and of the complete clinical trials process
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.
Our clients offer a challenging and diversified position in a dynamic and ever evolving start-up atmosphere! You would have the chance to get involved in the evolution of a human size company.
Our clients are startups and SMEs active in Biotech, Medtech and Hightech. They generally offer opportunities in a very dynamic and fast-growing environment!
How to apply ?
If you are interested in this type of challenging opportunities, please address your application to our recruitment team email@example.com or directly on www.plusonesearch.be
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