Feasibility Manager - Post Award

Position Summary:

Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine.  As part of this team, this role has responsibility for the management and delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Feasibility Manager leads pre-award feasibility projects and supports business development and operational strategy teams by conducting detailed feasibility analysis and presenting at internal and client meetings. The Feasibility Manager leads feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification, study strategy(ies) and enrollment modeling. In addition, Feasibility Manager participates in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to: 

- Leading pre-award feasibility projects

• Provide detailed pre-award support to operational strategy and business development teams:

▪ Provide feasibility analysis and input for pre-award RFPs, including: competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis

▪ Provide enrollment modelling(s) for agreed study strategy(ies)

• Undertake feasibility site outreach for pre award opportunities
• Support and/or attend BDM and client calls
• Apply process, templates and delivery standards for feasibility pre-award

- Leading post-award feasibility projects

• Provide guidance for post-award, rescue and standalone feasibility in alignment with study and client requirements
• Manage feasibility project team in all aspects pertaining to the conduct of the feasibility:

▪ Provide training and training materials

▪ Ensure that feasibility project team is meeting agreed timelines and deliverables

▪ Ensure accuracy and quality of the survey data

▪ Oversee and /or conduct the site outreach process.

• Present feasibility strategy at KOM and provide regular updates to sponsor
• Where appropriate, engage with patient advocacy groups and site networks in order to support study feasibility, recruitment and successful delivery
• Conduct the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility

- Participate in growth of the Feasibility Department and Precision for Medicine:

• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre and post-award
• Ensure that post and pre award feasibility process, SOPs templates and tools, are implemented and followed
• Support development of feasibility process documents and SOPs
• Support Business Development in client meetings and bid defense presentation

Qualifications:

Minimum required:

• A minimum of 7 years of related experience
• A Bachelor’s degree in a life sciences discipline
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative

Other Required:

• Competence and relevant experience in the required activities for the role including feasibilityanalysis, site identification
• Domestic and international travel including overnight stays up to 10% of time
• Ability to communicate both verbally and in writing at the English proficiently (Professional level).

Preferred:

• Postgraduate degree preferred

Skills:

• Excellent management and organizational skills
• Strong oral and written communication skills in English
• Strong rationale and analytical thinking
• Established IT platform and data analysis skills
• Active listening and strong presentation abilities
• Able to collaborate with diverse stakeholders
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Strong attention to detail
• Team player with ability to work independently
• Willingness to work in a matrix environment, work independently and as part of a dynamic team
• Embraces the established Precision for Medicine’s Cultural Values as an underlying tenet to drive work behaviors
• Demonstrates good knowledge of ICH-GCP, relevant Precision for Medicine’s SOPs and regulatory guidance, as well as the ability to implement such items.