Senior Feasibility Strategy Lead

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be office or home based in the UK, Ireland, Lithuania, Spain , Italy, Hungary , Romania or Poland. The offices are open planned, and you will be working in an innovative and collaborative environment with your international peers and colleagues.

As the Senior Feasibility Strategy Lead you will acts as the senior functional lead assigned as part of the core project team responsible to drive all feasibility and site identification activities immediately after award on all types and phases of studies including programs. Working independently, you will be responsible to deliver an optimized operational strategy, based on selection of countries and clinical sites best positioned to successfully execute the trial/program.

You will act as a mentor for other staff in the department by engaging them in all types of feasibility and site identification activities through the mentorship period. Depending on the business needs, you will occasionally lead pre-sales feasibility assessments in support of strategic bids for mega studies or partnership programs..

Key Accountabilities:

Protocol Feasibility & Country Selection

- Through in-depth review of protocol design, competing landscape, and recruitment benchmark data, conduct initial protocol feasibility assessment or revise pre-award protocol feasibility assessment taking into account new data received/collected after award via standard and non-standard sources of information as appropriate.

- Conduct initial country selection analysis or adjust pre-award country selection analysis via available country selection tool/platform based on new data received/collected after award using standard and non-standard sources of information as appropriate and deliver protocol-specific country recommendations including solid data-driven rational.

- Independently manage country clinical operations survey including development of the protocol-specific questionnaire, collection and review of country data, follow-up discussions with local clinical operations representative, and compilation of collected information into country selection analysis, scenario modeling, and site identification strategy.

Site Identification

- Develop and implement program-specific site identification strategy to produce initial lists of sites as per departmental and partnership quality standards.

- Using the standard template, design a program-specific site questionnaire based on the available study information, the Sponsor questionnaire if any, and agreed site selection criteria that will enable an in depth analysis of the responses and will highlight the protocol challenges as viewed by the investigators as well as enable the selection of most appropriate sites.

Miscellaneous

- Independently act as Project Leader on stand-alone feasibility studies, which includes the following additional responsibilities: - Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, project management, including milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, production of key project progress reports, and management of communication.

- Provide oversight and support pre-award activity when needed.

QualificationsEducation:

- Preferred degrees may include but are not limited to: Bachelor of Science, Bachelor of Science in Nursing, Masters, MD, PhD and/or comparable life skill experience.

Skills:

- Strong analytical skills applied to business needs

- Excellent interpersonal, verbal and written communication

- Demonstrated leadership and mentoring capabilities, and ability to influence others

- Creative problem-solving skills, which supports client-focused approach to work

- Ability to adapt to change with respect to work assignments and new learning opportunities

- Ability to prioritize workload with while maintaining quality and attention to details

- Capability and willingness to work in a matrix environment and values the importance of teamwork

- Ability to work independently and in a decentralized reporting model (as applicable).

Knowledge and Experience:

- Strong relevant clinical research experience in management of international clinical trials

- Demonstrated expertise of feasibility requirements is essential

- Previous exposure to development of clinical trial strategy, modeling of enrollment scenarios, and selection of country/sites

- Fluent in written and spoken English and local language

In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and for your hard work you will be rewarded with a competitive base salary as well as a benefits package including holiday pension as well as other leading-edge benefits that you would expect with a top company in the CRO Industry.