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- This role is key for assessment of feasibility of clinical trials proposed or to be performed by the Clinical & Sciences Operation Platform (C&SOP) of Sanofi-Aventis R&D. The Feasibility Manager (FM) is the central point of contact for coordination and conduct of the feasibility assessments and provide reliable and consolidated results at the C&SOP level utilising wide sources of data (including but not limited to prediction of source of patients, rate of recruitment, predicted prescreen and screen fail rates). This will include an appropriate geographic deployment for the conduct of a given indication or study to optimize the feasibility in the perspective of cost effectiveness, respect of timelines and quality.
The FM will also provide proposal regarding patients recruitment strategy and scenario modeling in order to improve the reliability of recruitment forecasting at region, clusters or country level. With the goal of optimal subject recruitment, he/she drives the development of processes and tools that integrate strategic study placement into sanofi-aventis clinical research practices.
He/she will work in very close collaboration with the Clinical Study Director assigned to the study and under supervision of the Lead Medical Operations for the domain or therapeutic area.Part of the Clinical Trial Team, he/she will be accountable for feasibility process and will collaborate and interact with Clinical Study Units or Clusters and especially and mainly with Medical Advisors.
To better serve some customers (Oncology, Diabetes, …), experience or qualification in a medical specialization will be required or at least appreciated.
- All clinical studies or projects related to clinical development (excluding Clinical & Exploratory Pharmacology studies).
- From a draft proposal (e.g. study synopsis) to end of study recruitment.
- Deliver clinical study pre feasibility or feasibility assessments and proposals and patients recruitment strategies.
KEY INDIVIDUAL ACCOUNTABILITIES
- To provide Feasibility advice and strategic recruitment planning and site support for projects to be proposed to the C&SOP,
- To conduct the appropriate evidence based Feasibility for study/project with the CSD and other team members (especially Medical Advisors in CRUs),
- To prepare Feasibility Questionnaires, documentation required for the feasibility in collaboration with the CSD,
- To provide reliable feasibility assessment based on solid assumptions and risk assessment,
- To obtain an appropriate geographical deployment of a given indication or study in order to:
- ensure the feasibility of the implementation of study protocols
- improve the reliability of recruitment forecasting at regions/ country level
- To analyze continuously initiated clinical trials and implement action plans or back-up plans as needed,
- To maintain relevant systems, database and performance metrics,
- To analyze past performance, epidemiology and database data to produce accurate, robust and timely feasibility information,
- To prepare a recruitment strategy proposal at the CSU, Cluster and Region level for review and approval by Head of Region,
- To develop interaction with Medical Advisors in CSUs and Clusters for the best knowledge of the study, compound, protocol, …. in CSUs and participating countries,
- To provide appropriate and timely, high quality, customer focused proposals, tools, processes, develop training material in collaboration with the CSD and input for patient recruitment and retention strategy,
- To continuously research and communicate industry trends in global clinical trials including emerging markets and technology based innovations,
- To represent Department on cross-functional teams and task forces,
- To ensure components of feasibility strategy are fully implemented by stakeholders,
- To facilitate collaboration across regions/countries to establish appropriate subject allocation according to strategy,
- To facilitate communication of learnings and best practices among team members and across therapeutic areas,
- To support the CSUs to identify potential investigators and to develop network using and developing tools and data base.
KEY SHARED ACCOUNTABILITIES
- With CSD, feasibility results and support medical training to study team, CSUs (Medical Advisors, monitoring, …) and investigators,- With Business Office and Project Leader in the CSO Platform, assessment of cost effectiveness according to the geographical deployment of the study,
- With Trial Operations, patients recruitment timelines and applied patients recruitment strategy,
KEY LEADERSHIP BEHAVIORS
- Team spirit,
- Clear and effective communicator,
- Expertise in the domain of assigned study/project
- Interest and ability to teach,
- Customers (medical project leader in Unit, …) & quality focused
- Negotiation skills
- Highly developed analytical skills
- IT literate
PARAMETERS FOR SUCCESS
- Customer satisfaction (Units, …)
- Respect of timelines for feasibility
- Protocol amendments (low number)
- Sites participation and recruitment according to plan
- Minimal requirement to back-up or rescue plans
- Develop parternship and team spirit with CSD, Project Leader and Study Managers and
- Strong collaboration and interaction with Medical Advisors in CSUs
- Advice and Input on feasibility for a clinical study/project
- Conduct feasibility process
- Interactions with Medical Advisors in CSUs for Feasibility and other potential stakeholders (e.g. regulatory, marketing, market research).
- Influences- Best approach for study conduct
- Patient recruitment strategy
- Vetoes- Non feasible proposals
- Non ethical proposal according to local practices
- Degree in Sciences or Pharma or Medicine.
- Experience in Clinical Development, especially relevant experience in multinational study management in a medical specialization would be appreciated.
- Knowledge in ICH, GCP and local regulations.
- Knowledge in Epidemiology or/and Data Management would be appreciate to develop new skills in feasibility process.
- Fluent in English. M*
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