Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Due to our continued growth, we are seeking a Feasibility Manager who will be a core member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, they will have responsibility for the management and delivery of pre and post award feasibility projects, and site identification. Feasibility Manager will support the study teams and business development team by representing the feasibility at pre and post award meetings. In addition, this team member will participate in specific projects that will enable 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. We can consider candidates working remotely in the UK, Spain, Hungary, Poland, Romania, Serbia and Slovakia.
Main responsibilities of the job include, but are not limited to:
Feasibility pre award
Provide detailed Pre-award Support to Operational Strategy and BD teams:
- Provide feasibility analysis and input for pre-award RFPs, including, but not limited to: competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis
- Propose data driven study strategy (es), build enrollment modellings with highest probability for success
- Assist in the development of the feasibility budget
- Support and/or attend BDM/ Client calls on behalf of feasibility
- Support transitioning pre-award feasibility/strategy to feasibility project teams
- Undertake the delivery of site outreach (if requested) feasibility for pre award opportunities
- Apply process, templates and delivery standards for feasibility pre award
- Provide training and training materials to support pre award Feasibility.
Post award feasibility
- Lead post award and standalone feasibility in alignment with study and client requirements
- Provide guidance to PfM teams supporting feasibility projects
- Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility
- Manage and/or conduct the data driven research and analysis to provide accurate study planning and site identification information for assigned studies
- Drive the strategy and success of feasibility projects
- Work on issues where analysis of situations or data requires conceptual thinking and an in-depth knowledge of organizational objectives.
- Implements policies and selects methods, techniques, and evaluation criteria for obtaining result.
- Oversee and /or conduct the site outreach process for site identification
- Ensure accurate and quality of the survey data including QC of department deliverables
- Provide training and training materials to support post award feasibility
- Where appropriate, engage with patient advocacy groups and site networks in order to support study feasibility, recruitment and successful delivery
Participate in growth of the Feasibility Department and Precision for Medicine:
- Interact with lower and/or senior management on matters concerning several functional areas, department, and/or customers.
- Serve as a mentor, supervisor and support for more junior feasibility members
- Train new team members on processes and platforms
- Ensure that post and pre award feasibility process, SOPs templates and tools, are implemented and followed
- Support Business Development in client meetings and bid defense presentation
Qualifications:
Minimum Required:
- Advanced degree in a life sciences discipline or equivalent relevant experience. Postgraduate degree preferred
Other Required:
Preferred:
- Approximately 5 years in the CRO/Pharmaceutical industry or equivalent relevant experience
- Competence and relevant experience in the required activities for the role including feasibility analysis
Skills:
- Strong management and organizational skills
- Strong oral, written communication skills in English
- Strong rationale and analytical thinking
- Strong 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
- Willingness to work in a matrix environment, work independently and as part of a dynamic team
- Accomplished at maintaining a sustained focus at the macro level while being able to manage at the micro level as needed
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective in delivering results with appropriate quality and timeline performance
- Embraces and embodies the established Precision for Medicine’s Cultural Values as an underlying tenet to drive work behaviors
- Demonstrates mastery knowledge of ICH-GCP, relevant Precision for Medicine’s SOPs and regulatory guidance, as well as the ability to implement such items.
Travel required
- Domestic and international travel including overnight stays.
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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