Principal Dedicated Solutions Consultant



Posted on Thursday, June 13, 2024

About the Role and Team:

OpenClinica is a growing SaaS company in the clinical research industry that helps Customers accelerate the process of bringing new medicines and devices to market. Customers around the world rely upon our suite of solutions to increase productivity across a diverse spectrum of clinical research models and settings. Our mottos of, “making the complex easy” and “better data, faster,” reflects our commitment to improving healthcare as innovative problem-solvers who are passionate about technology!

The Principal Dedicated Solutions Consultant is a unique role at OpenClinica. You will be part of a specific assigned client project team. You will act as an embedded team member, in a sense as an extension of the client's organization. Leveraging your industry knowledge along with strong relationship building skills to help guide, advise and prioritize daily and ever-shifting priorities. You’ll be expected to partner with the assigned client on their objectives and deadlines while adhering to OpenClinica procedures and product configuration best practices. You will be primarily responsible for the configuration of our suite of products for our Customers’ clinical trials, participating in a wide variety of special projects and managing all aspects of project deliverables with regards to status reporting, budget and risk mitigation. Additionally, this role may assist Customers’ with general consulting needs and in partnering with Product, Engineering, Customer Support, and the accounts’ Customer Success Manager based on business needs.Â

Location: 100% Remote in the U.S. (Pacific or Mountain Time Zone preferred.)

Status: Full-time

Reports to: VP of Client Services


What You Will Do:

  • Exercise extreme agility and flexibility with shifting priorities and strict deadlines.
  • Lead study configuration activities in accordance with OpenClinica design best practices.
  • Interpret protocols, synopsis or Customer specifications to guide design decisions.
  • Conduct formal requirements gathering, development and testing sessions based on complexity and scope of study design and/or special projects. This may include integrations and data migrations, which may require involvement of third parties.
  • Create specifications for customer requirements based on complexity and scope of work.Â
  • Ensure compliance with all industry regulatory agencies.
  • Manage customer UAT activities, leveraging the power of OpenClinica’s EDC product, using interactive sessions with customers to complete fixes in real-time.Â
  • Coordinate activities involving other team members from across Professional Services, Customer Support, Product, and Engineering.
  • Partner closely with the assigned Customer Success Manager to monitor, improve and expand the customers relationship with OpenClinica. Work together to implement internal scorecards, identify account trends and make recommendations for improvement.Â
  • Provide consulting services on various special projects based on Customer business needs.
  • Manage project deliverables and identify areas of risk with mitigation plans for scope, resources, budget and timelines.
  • For larger projects, provide regular Status Reports, Project Plans and implement other tools for proper oversight (RAID logs).
  • Proactively work with the Product team to report bugs, usability issues, and share ideas for how our software could be improved.
  • Contribute improvements to OpenClinica design best practices and methods for building effective studies, focused on quality and efficiency.


Qualifications and Skills:

  • Deep experience in managing customer expectations, challenges, and tight deadlines.
  • Strong experience in working with demanding customers and high pressure situations.Â
  • Prior experience with study configuration of other EDC systems such as InForm, RAVE, Medrio, Castor, RedCap or others.Â
  • 5+ years’ experience in the Life Sciences industry, either in Technology or Pharma/Biotech settings.Â
  • Experience with configuration of integrations such as IVRS, CTMS, Labs and other clinical technologies.
  • Experience with data migration activities from other EDC systems.Â
  • Experience leading successful projects of varying size and complexity.
  • Familiarity with Project Management tools and activities such as SmartSheets, MS Project, RAID Logs, Status and Budget Reporting.
  • Experience managing diverse teams in a remote setting.
  • Excellent communication skills, both written and verbal.
  • Ability to converse comfortably with varied audiences (based on skill set, experience, business and technical teams, etc).
  • Strong organizational skills.

Nice to Have:

  • Experience with ARO’s and CRO’s
  • Prior Consulting experience
  • Familiarity with data management standards such as CDISC, CDASH, ODM and others.
  • eCOA experience


What’s in it for you?

  • Insurance and Benefits effective on your Hire Date.
  • Company Paid Flexible Time Off and 10 Paid Holidays each year.
  • 401(k) with company match.
  • Professional growth and development.