Global Feasibility & Site Engagement Manager

Location
US;Homeworking
Salary
Competitive
Posted
21 Jul 2021
Closes
19 Aug 2021
Ref
2021-15801
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

The 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 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 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.

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

  • Applies project management methodology, leadership and problem-solving skills to pre and post award feasibility assessments to support project level objectives, goals and deliverables.
  • To 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.
  • Expertly mine, review, dissect and interpret clinical trial business intelligence information, data analytics, site reported data and systems in various formats to apply to individual assessments, drive multi-functional discussion and derive recommendations related to protocol, country, accrual rate and site components of assigned assessments.
  • 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 of study documents and preparation of summaries for teams involved in feasibility activities.
  • Review of scientific literature and self-training pertinent to feasibility activities.
  • 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 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.

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, with at least 2 years in direct CRO Feasibility experience. CRO experience should include working knowledge of conduct of protocol, country and site feasibility assessments, study management logistics, regulatory/start-up logistics, trial designs, and country-level nuances.
  • In-depth knowledge regarding the drug development process, operational conduct processes and challenges within clinical
  • Knowledgeable of frequently utilized feasibility systems in the CRO and trial conduct industry.
  • 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 Excel, Word, PowerPoint and frequently utilized business intelligence tools (i.e. Citeline, Claims Databases, Impact Assessment Tools, Survey Tools, etc.)
Role Competencies:
  • Maintains a focus on key priorities and deliverables, staying resilient in the face of pressure.
  • Uses challenges and new situations as an opportunity to learn and improve. Understands own "facts" and "stories" when in dialogue, and the impact leadership style can have on outcomes.
  • Actively listens and learns from others, demonstrating patience and consideration for others' concerns or frustrations. Asks questions for clarification and ensures message is understood. Takes time to digest what is heard before responding.
  • Visible, approachable, and accessible. Encourages input and participation from colleagues to solve problems and innovate. Provides correct balance of direction and support to staff and colleagues according to each situation. Understands differences, anticipates areas of conflict and takes action.
  • Evaluates and measures current processes. Works with a view of the future, prioritizing work in line with organizational objectives. Improves processes to maximize use of resources.
  • Seeks opportunities to develop professional skills and knowledge and encourages team to do so. Supports and directs where appropriate, including recognizing achievements and providing constructive feedback and guidance. Cross-train others to broaden experience and develop potential.
  • Translates major new directives into individual performance expectations. Explains and convinces others of the need for adaptation and change of policies, structures, and methods.
  • Is comfortable facing issues with team members quickly and directly. Is willing to choose an approach that has not been tried before, or a leadership style that feels less comfortable if the situation demands it. Takes personal risks regularly and is not afraid to express bold opinions if the intention and motive is good.
  • Consistently reflects the REAL values and inspires team 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.