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Project Manager

Open 49d
About Us:

Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.

Position Overview:

The Project Manager is the primary client interface for client implementations, from initial engagement to study closedown. Project Managers are responsible for managing projects through the software development lifecycle and through study maintenance while working collaboratively with teammates and maintaining exceptional client satisfaction.

As a Project Manager, you are the primary point of contact for our clinical trial sponsor and CRO clients from the moment their Randomization and Trial Supply Management (RTSM) system goes live through the life of the study. You own the day-to-day client relationship, the project plan, and the coordination across internal teams needed to keep the trial's randomization and drug supply operations running smoothly.

This is a delivery and relationship-management role, not a system-build role: you inherit a validated, go-live-ready RTSM system from the BSA and study build team, and you are accountable for everything that happens with that system in production — change requests, user management, ongoing supply strategy conversations, issue triage, and study close-out.

*This position can be based remotely within the US.

Responsibilities:

  • Serve as the single point of contact for the client (sponsor/CRO) for all RTSM-related activities post go-live, building trusted, long-term relationships across the life of the study.

  • Lead recurring client status calls and steering committee meetings; own the agenda, minutes, and action item tracking.

  • Manage the end-to-end change control process for live systems: intake change requests, scope impact, coordinate with Design/Build, QA, and Biostatistics, and drive changes through validation and deployment.

  • Own the project plan, timeline, and RAID (risks, actions, issues, decisions) log for each assigned study post go-live.

  • Coordinate site and depot user provisioning, training refreshers, and access issues in partnership with the Help Desk and Training teams.

  • Monitor drug supply forecasting, inventory thresholds, and resupply strategy conversations with the client, escalating operational risk proactively.

  • Manage study amendments (protocol amendments, dosing changes, new sites/countries, IP updates) from client request through implementation.

  • Coordinate UAT (user acceptance testing) for any post-go-live system changes with the client and internal build teams.

  • Track and communicate study metrics (enrollment, randomization, supply status) to the client and internal leadership.

  • Own financial tracking for the account, including change order scoping, budget tracking, and invoicing coordination with the client and internal finance.

  • Lead study close-out activities: final reconciliation, system decommissioning, archival, and lessons-learned reviews.

  • Act as the internal advocate for the client, partnering with Sales, Design PM, Programming, QA, and Regulatory to resolve issues quickly.

  • Maintain audit-ready documentation in accordance with GxP, 21 CFR Part 11, and internal SOPs

Authority:

  • The Project Manager has the authority to assess and manage risks associated with assigned client IRT systems and change requests, and to make informed decisions and recommendations within defined project, client, and governance frameworks

Accountabilities:

  • Demonstrate consistent, accurate, and timely completion of all responsibilities.
  • Effectively utilise available resources to drive timely study delivery while maintaining clear oversight, accountability, and appropriate documentation.

Education:

  • Bachelor's degree or equivalent preferred, or appropriate work experience.

Experience:

  • 2+ years of Project Management experience in clinical trials, RTSM/IRT, clinical supply chain, or a related life sciences/technology field
  • 2-4 years’ experience in the life science industry
  • Previous experience working in a fast-paced, entrepreneurial environment preferred.
  • Familiarity using SQL a plus
Endpoint Clinical does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to Endpoint Clinical will be considered Endpoint Clinical property, and Endpoint Clinical will not pay a fee should it hire the subject of any unsolicited resume.

Endpoint Clinical is an equal opportunities employer AA/M/F/Veteran/Disability.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment, qualified applicants with arrest and conviction records.
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What this application asks

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Resume/CV, Full name, Pronouns, Email, Phone, Current location, Current company, LinkedIn URL

  • How did you hear about this job?
  • Do you have a relative that is currently employed by Endpoint? choose one · optional
  • If you are under 18 years of age, can you provide required proof of your eligibility to work? choose one · optional
  • Are you legally authorized to work in the United States? choose one · optional
  • Will you now, or in the future, require sponsorship for employment (e.g., H-1B)? choose one · optional
  • Are you currently on "layoff" status and subject to recall by another organization? choose one · optional
  • Can you travel if your job requires it? choose one · optional
  • Have you entered into a non-disclosure or non-compete agreement or understanding of any kind with any previous employer? choose one · optional
  • Desired Salary
  • This is to notify you that personal data about you has been collected by Endpoint Clinical L.P. (“Endpoint”), which is located 8045 Arco Corporate Drive, Suite 250, Raleigh, NC 27617 and can be contacted by emailing [email protected], because Endpoint wishes to evaluate your candidacy for employment. Your personal data was either obtained from an application via a job board or website, publicly available sources (e.g. LinkedIn) or provided to Endpoint by someone who referred you for potential employment. Your personal data will be processed for the purposes of managing Endpoint’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by Endpoint, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data has been shared with Lever, Inc., a cloud services provider located in the United States of America and engaged by Endpoint to help manage its recruitment and hiring process on Endpoint’s behalf. Accordingly, if you are located outside of the United States, your personal data has been transferred to the United States. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer was subject to appropriate additional safeguards under the EU-US Privacy Shield Framework. You can obtain a copy of the standard contractual clauses by contacting us at [email protected]. Your personal data will be retained by Endpoint for two (2) years after notifying you of the outcome of the recruitment exercise. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority. choose one · optional
  • Depending on your previous experience, Endpoint may choose to consider you for other positions within the company. Do you allow for Endpoint to use the information submitted in this application for that purpose? choose one · optional

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