E.O.N Worldwide

E.O.N Worldwide

Senior Director of Clinical Projects, Clinical Assessment Technologies

Research Triangle Park, North Carolina · Director

Sponsorship not specified$141k-$279kDetected 12 days ago
GCPData AnalysisStatisticsProject ManagementBusiness DevelopmentExcelProcess ImprovementClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMentoringPublic SpeakingOrganizational SkillsMicrosoft OfficeGxP

About the role

  • Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers.
  • We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
  • The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Responsibilities

  • Drive identification of process improvement needs and coordinate initiatives to support these activities
  • Lead new quality management document (QMD) developments, including authoring and reviewing QMD and guidance documents
  • Create and lead CAT committees to further initiatives
  • Drive business development activities for CAT, including proposal input, participation in capabilities presentations, and bid defense activities
  • Provide oversight, training, and support for the clinical team
  • Support scale acquisition activities, including scale versioning
  • Accountable or consulted, depending on study assignment, on source document creation to ensure materials align with study protocols
  • Lead development of data surveillance plans and oversee execution of data surveillance throughout trials
  • Manage clinical staff directly
  • Lead vetting, hiring, and onboarding of new clinical staff

Requirements

  • Master's degree in life sciences or equivalent
  • At least 10 years of clinical trial experience with clinical assessments, including independently organizing and conducting projects and presenting at Investigators' Meetings or similar forums as an expert clinician
  • Strong applied knowledge of pivotal efficacy measure administration conventions and the ability to train assessors
  • Knowledge of operational aspects of Phase I-IV clinical research trials and experience working with a Contract Research Organization or Rater Training Organization
  • Excellent knowledge of SOPs, ICH/GCP, and regulatory guidelines
  • Ability to travel domestically and internationally to attend key meetings, with flexibility to accommodate global time zones as needed
  • Promotion to the next level is not automatic based on years of experience.
  • Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Nice to have

  • Preferred minimum of 4 years of experience managing team members or providing direct clinical mentorship

Skills

  • Strong organizational skills with a detail-oriented- and service-oriented approach and excellent management capabilities
  • Strong understanding of best business practices related to rater training, methodologies, and corporate discipline
  • Ability to consistently meet timelines and work effectively under pressure
  • Open to constructive and developmental feedback
  • Excellent written and verbal communication skills, with the ability to clearly and concisely present information
  • Ability to exercise sound judgment and make independent decisions
  • Proactive in identifying and escalating potential project issues to the appropriate CAT and Worldwide Clinical Trials staff
  • Basic knowledge of statistics
  • Self-starter mindset
  • Strong proficiency in Microsoft Office applications, including Word, Excel, Teams, and PowerPoint

Compensation

  • will fall within the provided range, and it not a guarantee of exact salary.
  • The final salary will be determined based on relevant experience, performance, education, and internal equity.
  • In addition to base salary, we offer a competitive benefits package depending on location.
  • We ensure pay equity and transparency and comply with all applicable labor laws.
  • Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

Company info

  • We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
  • We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
  • Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
  • Why Worldwide
  • We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe.
  • It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
  • We believe everyone plays an important role in making a world of difference for patients and their caregivers.
  • From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed.
  • We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
  • The Director of Clinical Projects is accountable for all aspects and oversight of clinical activities in support of the protocols awarded to Clinical Assessment Technologies (CAT), including protocol input and reviews, assessment training development and activities, data surveillance activities, and other clinically focused content and tasks.
  • The Director of Clinical Projects is also responsible for strategizing and leading departmental clinical initiatives while ensuring all assigned projects are conducted in a timely manner and in compliance with standard operating procedures (SOPs), International Council for Harmonization/Good Clinical Practice (ICH/GCP), and regulatory guidelines.
  • In addition, this role collaborates and co-leads with CAT Operational Leadership regarding sponsor program deliverables and has direct supervision and mentoring responsibilities for CAT team members.

Visa & Work Authorization

  • In addition, this role collaborates and co-leads with CAT Operational Leadership regarding sponsor program deliverables and has direct supervision and mentoring responsibilities for CAT team members
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