- Do you have Phase I-Ib clinical trial experience?
- Experienced preparing and interpreting Phase I budget proposals?
- Have knowledge of the operational nuances within Phase I study design and related budget impacts?
- Interested in joining a new team, with some client-facing exposure, where you will work closely with commercial and operational teams?
We are looking for someone who will work closely with commercial and operational teams, providing external site analytics, feasibility information, site capability, country-specific and multi-centre strategy considerations. You will maintain the Strategy & Planning Study Resourcing database for our clients in support of CPS clinical trials.
You will actively support the growth of the business through feasibility, data collection and analysis, study planning support, and provides new insight to grow commercial activities through data driven solutions.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19, 000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Opportunity is available for those located in the UK, Romania, France or South Africa
Essential Duties
Strategic Planning Support (i.e., site network capabilities, data analysis and interpretation for feasibility, strategy and planning, etc.) - 70%
- Assist in study feasibility, assessment and the development of strategic study plans by providing the relevant information for business opportunities, including industry intelligence, literature resources, client solutions and objectives.
- Leverage CPS software tools and databases to generate data in support of:
- Global feasibility
- Enrollment estimates
- Site Performance Analytics
- Study timeline projections for resourcing
- Identifies list of potential external sites to support strategy based on feasibility assessment, capabilities, SPA data, experience and risk.
- Conducts site outreach, interest and feasibility, prepares redacted synopses, SOEs, and protocols for external site outreach.
- Accountable for the CPS Strategy & Planning Study Resourcing database upkeep, analysis and presentation of key metrics for implementation of external site strategies for CPS clinical trials.
- Analyze data and report metrics on external sites for pre- and post-award study deliverables - RFIs/RFPs, BDMs, client calls, capabilities presentations, site governance and escalation or investigations, etc.
- Produce reports and outputs with minimal supervision from more senior department staff.
- Accountable for site deliverables in support of Request for Proposal (RFP) and Request for Information (RFI) including timelines, budgets, proposals, information for BDMs, issue escalation, etc.
- Reviews strategies for completeness and quality in white papers, executive summaries, key parts of proposal documents, feasibility assessments, competitive pipeline analyses and other strategy documents.
- Deliver accurate, high quality deliverables to timelines and expectations.
- Active participation on cross-functional teams that plan, analyze, and implement short-term and long-term solutions to drive new business initiatives.
- Supports S&P team in refining external site strategies upon scope change, rescue, or sponsor-requested changes.
- Identifies and communicates potential project-specific or external site risks, quality concerns, issue or conflict escalation and works together with Strategy & Planning Leadership on mitigation and resolution.
- Provide updates on monthly applicable site metrics for department, including metrics for external site quality, audit history, issue escalation and resolution in support of site success initiative external site feedback pre-, during, and post-study follow up.
- Maintain external network structure (core/primary, secondary, tertiary) for rapid study startup, and works with external network to progress towards primary partnerships.
- Assesses external site and study risk, proactively engages leadership, site, and project management to mitigate risk.
- Participate in the preparation of appropriate user manual / work instructions.
- Identify improvement areas of the departments tools and processes.
- Support the departments involvement in work streams, initiatives, new tools and technologies as directed by department managers. Work on any other tasks as delegated by department managers.
- Practical experience and understanding of global drug development and clinical trials, specifically surrounding proposals within Phase I trials.
- Strong data mining and analytical skills with the abilities to review/analyze relevant data so as to assist in building solution driven clinical trial strategies.
- Strong technical/scientific writing skills and analytical skills.
- Strong attention to detail/quality control skills.
- Strong critical thinking and reasoning skills to efficiently solve problems and make informed decisions.
- Strong networking abilities and an ability/willingness to work with individuals across the globe. Persistent and able to influence others.
- Good communication, planning and organizational skills.
- Ability to work independently and successfully within a team.
- Demonstrated ability to handle multiple competing priorities effectively. Ability to reset expectations under direction of senior staff.
- Ability to provide interpretation of data and / or reports and perform routine output delivery.
- Understanding and practical working knowledge of ICH-GCP Guidelines, including relevant international requirements/guidelines for the conduct of CPS studies.
- Understanding of global drug development and the clinical trial project management process, with a special emphasis on early phase studies, investigator sites and capabilities.
- A university/college degree (preferably in Life Sciences related field).
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortreas spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities.As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
, EMEA, Remote
Labcorp Is Proud To Be An Equal Opportunity Employer
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