Senior Global Feasibility & Site Engagement Manager

Location
Deerfield, IL, US;Homeworking
Salary
Competitive
Posted
31 May 2021
Closes
25 Jun 2021
Ref
2021-13942
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

***This is a work from home position that can be worked remotely***

The Senior Global Feasibility & Site Engagement Manager is a member of the Global Feasibility and Site Engagement team responsible for conducting pre and post award protocol, country and site feasibility assessments. This role leverages, analyzes 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 Advanced Clinical 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, 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.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

Responsibilities

  • Serve as primary contact for specified clients for the conduct of paid feasibility assessments.
  • 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 and others as assigned.
  • 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.
  • Applies project management methodology, leadership and problem-solving skills to pre and post award feasibility assessments to support project level objectives, goals and deliverables.
  • Establish and maintain trustful relation with client(s) by consistently delivering a high quality and reliable feasibility related services to specified client(s).
  • 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, Executives, Sponsor team members, Key Opinion Leaders and site staff to obtain necessary information, goals, feedback and opinions related to assigned feasibility assessments.
  • Review and understand study documents and prepare summaries for teams involved in feasibility activities.
  • Data mine and review scientific literature and conduct self-training pertinent to feasibility activities.
  • Explore and understand indication specific advocacy and social patient environment to integrate strategies and data into feasibility assessments from unique or patient-driven forums.
  • Develop feasibility assessment questionnaires, input into survey tools, assess data and collate to develop meaningful metrics to drive recommendations and decisions.
  • 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 Advanced Clinical mission.
  • Adhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians and policies and procedures.

Qualifications

  • BS or BA 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 within a CRO and/or the feasibility space is a plus.
  • In-depth knowledge regarding the drug development process, operational conduct processes and challenges within clinical
  • Knowledgeable of frequently utilized feasibility and business intelligence systems in the clinical trial industry.
  • In-depth knowledge regarding the drug development process, operational conduct processes and challenges within clinical
  • Expertise in internal and external relationship
  • 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 to the detai
  • Excellent communication and presentation skills, including written, spoken and listening
  • Demonstrated ability to work in a fast-paced
  • Demonstrated ability to lead cross-functional teams, including those that are of higher seniority.
  • Must have a positive demeanor 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, Impact Assessment Tools, GoBalto Select & Activate, etc.)
Role Competencies:
  • Established reputation as a credible, trustworthy global feasibility and site engagement subject matter expert for employees and cross-functional teams to rely on to execute, enhance sales.
  • Ability to transparently communicate with internal and external stakeholders to ensure project milestones and goals are achieved.
  • Ability to develop and build successful cooperative relations with all internal contributors to the proposal.
  • Ability to effectively coordinate and successfully manage feasibility assessment activities and weave resulting strategy into a customized solution response to meet the needs of Advanced Clinical's customers within agreed timelines.
  • Proactively discovers the needs of customers and creates solutions to meet the customer's changing needs. Works in partnership to improve customer experience.
  • Deliver high quality standards and strive for excellence; Act in a proactive, flexible and responsive manner to both internal and external customer needs.
  • Extensive experience and understanding of multiple therapeutic areas, willingness to apply therapeutic knowledge to areas of non-specialty or experience, study designs, clinical trial development strategy and applying this to feasibility strategy and execution to achieve feasibility goals.
  • Mastery of the skills and knowledge relevant to the function. Significant success in performing the most demanding assignments under minimum supervision.
  • Tenacious and self-motivated to uncover information outside of analytical tools/software to support and guide the functional team in medical and feasibility findings and outputs. Seeks opportunities to develop professional skills and knowledge.
  • Communicates broadly and strategically across teams to ensure project and goal status is clear with all contributing parties and with varied audiences. Ensures appropriate individuals are informed.
  • Demonstrates awareness, flexibility and willingness to adapt approach and/or apply different styles when the situation or individual requires it.
  • Keen level of organization and follow-up.
  • Remains poised and utilizes a consultative approach in internal and external communications.
  • Recognize, exemplify and adhere to Advanced Clinical's values which center around the REAL values and inspire peers and colleagues cross-functionally to live and work by these values.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

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