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Senior Account Director

King of Prussia, United States

CluePoints is a fast-growing company and the premier provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions to clinical development organizations.  A cornerstone of CluePoints value lies its powerful and timely ability to identify anomalous data and site issues enabling more pro-active and effective intervention and a significant reduction in overall regulatory submission risk.  CluePoints is seeking an outstanding candidate with strong project leadership and communication skills,  clinical operations and RBM expertise, and a passion for delivery excellence, to help drive customer success and broad adoption of the CluePoints solution.


Responsibilities 

  • Act as CluePoints Account Lead for enterprise-level clients, and as Project Lead for single-study engagements, taking primary accountability for ensuring client success.  Specific duties include at a minimum:

    • Build strong client relationships based on trust, integrity and a passion for delivery excellence

    • Ensure and oversee effective project management discipline throughout project lifecycles, including all appropriate aspects of project planning, tracking and associated communications

    • Ensure all CluePoints deliverables and commitments are made in a timely fashion with highest quality

    • Act as a point person for escalation and resolution of key issues

    • Provide RBM and/or CluePoints best-practice consultation whenever possible

  • Lead the development and delivery of consultative services covering RBM methodology and related topics, including the following specific duties:

    • Work with sales and marketing team, contributing to development of materials to support promotion of CluePoints consultative services

    • Lead the development of consulting modules, including all relevant support materials and content

    • Deliver standard and/or client-specific consulting engagements

    • Train and mentor other CluePoints staff on RBM/RBQM methodology and consulting

  • Provide ongoing feedback and input to CluePoints Product Team for recommended additions and/or enhancements to the platform.

  • Drive development of improved methods and tools for managing client engagements.

  • Develop expertise in all CluePoints solutions and all relevant features and functionality.

  • Provide active support to Business Development team:

    • Participate as an industry subject matter expert in sales engagements

    • Support development of RFP/RFI responses and related inquiries

    • Represent CluePoints at selected conferences/events, including speaking opportunities

    • Drive thought leadership on behalf of CluePoints, including authoring of articles/blogs and active participation in relevant industry consortiums/groups

 

Skills Needed 

  • Experience with project leadership and project management

  • Strong communication skills, including verbal, written and presentation skills

  • Experience working in a team environment under time and resource constraints

  • Flexible and adaptable to changing priorities

  • Expertise in clinical operations, including in-depth understanding of risk-based monitoring and related concepts - quality by design, quality risk management

  • Aptitude for data analytics and basic statistical concepts

  • Ability to travel – estimated at up to 30% of time

 

Qualifications Needed 

  • 7+ years of experience in a clinical research environment

  • Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, WHODRUG, etc.

  • College degree, preferably in a scientific or technical discipline


How to Apply 

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