Sr. Feasibility Lead
il y a 2 semaines
**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, NC
**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
Systems and processes
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
**Com
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