Senior Manager, Clinical Site Navigator (Open to Remote)

Location
Working from Home
Posted
May 21, 2022
Ref
4304918004
Required Education
Bachelors Degree
Position Type
Full time

SENIOR MANAGER, CLINICAL SITE NAVIGATOR (Open to Remote)

Position Summary:

The Senior Manager, Clinical Site Navigator (CSN) is a highly visible individual contributor role, a key position within Global Blood Therapeutics. The CSN will be responsible for providing holistic relationship management for a global network of Sickle Cell Disease (SCD) investigative sites participating in GBT studies. A key element of the role is dedicated to developing and maintaining relationships with key clinical site personnel and building a well-informed and motivated clinical site base for GBTs clinical development portfolio. The CSN is the face of GBT at the site level, governing the alignment of GBT and the site's operations to execute clinical trials efficiently, in compliance with all relevant company policies.

 Essential Duties and Responsibilities:

  • Build relationships with key sites in support of positioning GBT as their Sponsor of Choice. Governing the alignment of GBT and the site's operations to execute clinical trials efficiently, supporting quick site start-up (leveraging relationships) at site level, followed by consistent and anticipated enrollment while at the same time ensuring proper communication with internal cross-functional business partners, including study teams and other relevant stakeholders
  • Facilitates proactive operational solutions, such as remedial actionable solutions for any low or non-performing sites to ensure site productivity having direct impact on the business
  • Develops and maintains expert knowledge of site's staff and operations (e.g. decision makers, processes, standard operating procedures, etc.)
  • The CSN works in collaboration with site staff to establish a Key Stakeholder Map, identifying key decision makers within the site at an institution level
  • Drives consistencies and makes recommendations to achieve efficiencies across studies and programs
  • Participates in governance structure and oversight of GBT’s clinical research sites i.e., to ensure health of GBT’s and the site’s overall relationship, strategy, effectiveness and efficient execution of individual studies and portfolio
  • Facilitates the identification of clinical trial site (and corresponding community) educational needs around Sickle Cell Disease clinical trials, including awareness and understanding of challenges and potential solutions to anticipated or ongoing clinical trial issues
  • Partners with GBT stakeholders to evaluate and address KPIs/CAPAs with sites

Qualifications:

  • BA/BS degree or Nursing qualification with at least 6-9+ years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 6 years clinical trial experience
  • Hematology experience, direct working experience in the rare disease space, specific sickle cell disease a plus
  • Must have a strong understanding of US and EU/UK (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH GCP guidelines
  • Clinical Trial Operations experience in Gulf Cooperation Council Countries (GCC), Egypt, and/or Sub-Saharan Africa i.e. Nigeria, Ghana, Kenya, Zambia, Tanzania, Uganda ) a plus
  • Must have strong knowledge of drug development processes, clinical study design, study planning and management, and monitoring
  • Strong experience in working with CROs and other vendors
  • Must have effective communication (written and verbal) and interpersonal skills to represent GBT internally and externally
  • Excellent organizational skills and attention to detail
  • Excellent administrative skills and computer skills in the following programs: MS Word, PowerPoint, and Excel
  • Ability to travel domestically and internationally at least 60-70% or greater
  • Demonstrates a steadfast commitment to science and to patients
  • A problem solver, able to anticipate potential challenges to provide viable options and alternative paths to ensure a successful outcome
  • A leader who embraces open communication and debate in service of making informed and insightful decisions
  • Highly approachable and flexible, knowing how to break down barriers and promote sharing of information
  • Able to create a culture of one team, one purpose
  • An innovative thinker, who partners collaboratively with peers, advisors, and employees from across the organization to identify and achieve discovery goals
  • Entrepreneurial spirit, comfortable working with minimal supervision in a fast-paced global Clinical Operations environment, exceptional communication and interpersonal skills are necessary

 Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.