Founded in 1997, Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand, a full range of high-quality clinical research and trial management services under the Ergomed brand, and an internationally recognised specialist expertise in orphan drug development, under PSR. In December 2020, Ergomed acquired MedSource, a US-based specialist oncology and rare disease CRO. • 1200+ highly qualified professionals • Global full-service CRO • 23+ years of experience • Therapeutic specialization in oncology • Strong expertise in rare disease trials • Robust clinical safety system • Choice of leading drug safety databases Our key services include: • Clinical Research Services • Pharmacovigilance • Medical Information • Regulatory • Medical Writing • Site Management • Study Physician Support • Biostatistics • Patient Study Support
The Feasibility Manager is a member of the Global Feasibility team within the Study Start Up Business Unit responsible for conducting pre and post award protocol, country and site feasibility assessments.
This role leverages, analyses and consolidates all available data to build project strategy recommendations and actively provides guidance to facilitate educated decision making and ensures tailor-made strategies are put together that differentiate Ergomed from the competition resulting in compelling, feasible proposals and post-award assessments to continuously drive business growth and repeat business.
This role leads and manages the process of end-to-end feasibility to support the business development and operational teams for assigned pre-award assessments and serves as the primary lead on post-award assessments with support from multi-functional subject matter experts.
This role directs all aspects of assigned feasibility assessments including developing feasibility questionnaires, researching/compiling site/KOL lists, driving cross-functional collaboration and feedback, performing site outreach, compiling and assessing data analytics, inclusive of literature data mining, to produce meaningful recommendations, prepare feasibility findings report, presenting feasibility findings/ recommendations to internal and external stakeholders, while meeting all time frames and targets to meet or exceed project milestones to internal and external client’s satisfaction.
Perform as a technical expert in Feasibility process for internal and external clients and to provide strategic input to Business Development, Proposals, Operational Clinical Teams and Sponsors.
Execute on paid and pre-award feasibility assessments for strategic and/or key accounts.
Expertly mine, review, dissect and interpret clinical trial business intelligence information, data analytics, site reported data, literature and systems in various formats to apply to individual assessments, drive multi-functional discussion and derive recommendations related to protocol, country, trial design, accrual rate and site components of assigned assessments.
Provide protocol and country considerations and guidance to internal and external teams and for department-wide pre and post award feasibility assessments.
Confidently facilitate discussions amongst cross functional areas, Sponsor team members, Key Opinion Leaders and site staff to obtain necessary information, goals, feedback and opinions related to assigned feasibility assessments
Applies project management methodology and problem-solving skills to pre and post award feasibility assessments to support project level objectives, goals and deliverables.
Review and understand study documents, develop feasibility assessment questionnaires, input into survey tools, assess data and collate to develop meaningful metrics to drive recommendations and decisions.
Explore and understand indication specific advocacy and social patient environment to integrate strategies and data into feasibility assessments from unique or patient-driven forums.
Author feasibility findings reports and presentations as primary deliverable and serve as primary presenter to Sponsor and other applicable audiences.
Support, facilitate and engage with sites and PIs within and outside of site networks to encourage continued support, engagement and feedback for future assessments and potential study execution.
Routine assessment of project financials and monthly review of invoices.
Participate and/or manage other assigned activities to enhance the feasibility and site engagement offering, processes and overall Ergomed mission.
Conduct self-training pertinent to feasibility activities.
Establish and maintain trustful relation with client(s) by consistently delivering a high quality and reliable feasibility related services to specified client(s).
Adhere to strict code of confidentiality as it relates to sponsors, physicians and policies and procedures.
Reports to the Director, Feasibility
Degree in life sciences, business or healthcare field or comparable experience.
Minimum 5 years of professional experience in Clinical research and/or Drug Development. Experience should include working knowledge of study management logistics, medical management and protocol design, regulatory/start-up logistics, trial design, country-level nuances and robust protocol, country and site feasibility assessment conduct. Experience of working within feasibility space at both pre- and post-award within a CRO is a plus.
In-depth knowledge regarding the drug development process, operational conduct processes and challenges within clinical research.
Knowledgeable of frequently utilized feasibility and business intelligence systems in the clinical trial industry.
Inquisitive in nature, enjoys researching to uncover what may not be readily available and detailed orientated.
Must be able to see the "big picture" and project manage with detailed focus.
Excellent communication and presentation skills, including written, spoken and listening
Demonstrated ability to work in a fast-paced
Must have a positive demeanour with strong problem analytic and problem-solving skills.
Must have exceptional time management skills and the ability to work with individuals across various levels of the organization, as well as individuals across all levels outside of the
Consultative and collaborative approach when working with internal and external customers.
Computer skills, including at least intermediate proficiency of the use of Power Point, Excel and frequently utilized business intelligence tools (i.e. Citeline, EMR tool e.g. TriNetX, Claims Databases etc.)
Realistic chance of career progression and promotion