Core Accountabilities: Focusing on data driven estimates, benchmarking assumptions, robust scenarios & accurate planning, partners with colleagues in Clinical & Regulatory Operations to develop and deliver rapid, accurate and robust assessments of protocol and country feasibility, oversee site identification/site feasibility, and advise on timing of key start-up and recruitment milestones in support of operational planning and strategy for large, complex clinical trials. Participates in the development of proposals and bid defenses, works with the team to identify potential risks and propose effective solutions. Sr. Feasibility Lead can be home-based anywhere in the UK, US or EU or office-based in West Sussex or Morrisville.
Principal Responsibilities:
Protocol, country and site feasibility.Source and analyse data to develop strategies for proposals which deliver accurate and robust assessments of protocol, country and site feasibility, including patient recruitment plans, identifying potential challenges/risks associated with Sponsor specifications, the timing of key start-up and recruitment milestones, high level budget, and key assumptions.Understanding the patient profile and how this translates in the different geographical areas.Lead/contribute to the presentation of feasibility findings and recommendations internally and to clients, participating in bid defences as required.Review budget and text for proposals for which feasibility and/or site identification is included as the primary deliverable.Lead cross functional teams in standalone feasibility efforts.Develop and build strong relationships with all internal and external customers, ensuring clear communication channels.Develop and implement best practice for feasibility conduct, lead and manage processes relating to protocol, country & site feasibility and participate in global initiatives to improve operational efficiencies.Lead development, implementation, and maintenance of feasibility-related systems.Assist with ad hoc requests for departmental initiatives, including gathering updates and reporting performance metrics. Additional: The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
Essential Work Experience, Qualifications and Knowledge:
Extensive clinical trials feasibility and study start-up experience.Strong data mining and analytical skills, including manipulation and presentation of complex scientific data as it relates to clinical research.Demonstrated ability to manage projects and cross-functional processes.Broad based experience in clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations with strong understanding and experience in operationalizing clinical development programs in a global setting.Experience as Clinical Project Manager/Lead or Study Manager in a Contract Research Organization preferred.Bid defense experience preferred.Bachelor's degree in a life science discipline or equivalent experience. Cmed Core Values and Guiding Principles: All Cmed employees are required to exhibit and demonstrate the Cmed 'Core Values'.
Client focus: Satisfaction and Solutions
Dependability: Competence and Quality
Trustworthy: Open and Honest
Innovative: Approaches
Winners: Win-Win
All Cmed employees are required to follow Cmed's Guiding Principles:
We care about our customers, but are not afraid to say no or disagree.We only take on projects within our abilities to perform well.We always aim to do the right thing and approach every situation with good intentions.We pursue responsible profit and responsible growth, and spend money sensibly, as if our own.We believe organisation, management, governance and control are positive, but bureaucracy and micro-management are negative.We love common sense.We are the enemy of mediocrity.We have a hunger for innovation and a thirst for ideas.We show integrity and deal with mistakes.We acknowledge and value the contribution of others.We always strive to build an atmosphere that is positive, professional and fun.We are one Cmed Team.Attributes:
Planning and Organisational Skills: Well-developed strategic planning, observation, analytical operational execution and problem-solving skills.Demonstrated ability to handle multiple competing priorities effectively.Self-motivated with proven ability to work independently.Strong attention to detail/quality control skills.Works effectively under pressure.
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