Responsible for managing, tracking and building positive strategic relationships with company stakeholders and for providing robust feasibility assessments for clinical studies
- To be responsible for performing searches of company and public domain databases to assess the feasibility of study protocols and patient recruitment potential
- Creating the feasibility questionnaire that will be used for:
- Assessment of investigators’ interest, experience in clinical research and in the targeted therapeutic area, sites’ capacity to conduct the study, etc.
- Assessment of investigators’ experience in ICH GCP.
- Assessment of the overall number of target patients at a site and the number of patients that the site may enroll in the study.
- Assessment of site staff’s experience and the equipment necessary for study execution.
- Assessment of the timeline for approval and initiation of the sites.
- Assessment of other requirements for the study.
- To review protocols with potential investigators to assess whether sites are willing and suitable to recruit patients against specific protocols, evaluating the potential challenges and risks in performing a study.
- Assessing potential study sites and recommending sites for PSV in contracted feasibility in collaboration with the local SM(s), the medical team (Study Physicians/Medical Monitors), and the regulatory team.
- To manage the feasibility process and in to provide a data driven report to support proposals covering prevalence of an indication, standards of care by region, competing trials etc.
- To present the feasibility data to our sponsors using numerous Microsoft Office tools, as well as developing mitigation strategies for consideration
- To monitor actual performance versus feasibility
- To initiate vendor proposals collection and review in collaboration with all stakeholders
- To manage the complete feasibility assessments in a timely manner.
- To provide handover of awarded projects to the site identification team regarding relevant feasibility strategy proposed during RFP process.
- To lead and manage the process of clinical project feasibility during stand-alone feasibility (awarded) projects by managing and being accountable for the delivery of stand-alone service projects assigned to the individual.
- Ensures effective communication on all activities to relevant stakeholders
- Identifies additional processes and training needs
- Writing of SOPs on Feasibility Management
- Ensuring every vendor has CDA and is approved if applicable
- Responsible for creating, updating and controlling a feasibility tracker.
- In depth knowledge of clinical research regulatory and compliance requirements (i.e. ICH GCP)
- Bachelor’s degree in life science or related field or certification in a related allied health profession (nursing, medical or laboratory technology)
- Experience within clinical research gained within a pharmaceutical company and CRO environment
- Excellent customer service skills
- Sound judgement and decision-making skills
- Excellent organization and problem-solving skills
- Strong presentation, influencing and negotiation skills
- Advanced software and computer skills including MS Office applications
- Strong database interrogation skills.
- Excellent communication and interpersonal skills, including good command of spoken and written English language. Additional European languages desirable
- Proven ability to work through others to deliver results to quality, time and financial metrics
- Ability to establish and maintain effective working relationships with coworkers, managers and customers
- Ability to work independently and efficiently
- Excellent and proven presentation skills
- Competitive salary
- Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
- Multicultural environment, English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year
Report this job
Add to favorites
You need to be logged into your account to add this job to your favorites. Click "Continue" to log in or create a new account. You will then be able to access your favorites from our website or from the neuvoo mobile app.Continue
No, thank you