Clinical Systems Project Manager

Multiple Locations: United States • Raleigh, NC, USA • United Kingdom

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Requisition Number: 5643

Position Title: Clinical Systems Project Manager

External Description:

SUMMARY: Plans and manages the successful delivery of assigned clinical systems projects by ensuring high quality execution and work products and by meeting the established project budget and schedule

Tasks may include but are not limited to:

  • Plan project scope and timelines to ensure successful delivery by defining scope deliverable in shorter timelines (thereby breaking larger scope efforts into multiple smaller phased projects), by ensuring the availability of all necessary participants, and by identifying risks and corresponding mitigation plans
  • Provide oversight and accountability of deliverables, ensuring they meet Worldwide SOP’s, current Good Clinical Practice (GCP) and other applicable regulations
  • For projects that are a part of a larger effort, collaborate with other project managers and key stakeholders to ensure the project timeline aligns with the overall timeline and where possible allows for minor adjustments that do not impact the overall timeline
  • Liaise with staff and management as applicable to manage project budgets
  • When applicable, ensure that vendor contracts, budgets, schedules, and deliverables align with the project needs
  • Proactively identify the incidence of additional scope and work with stakeholders to determine the appropriate course of action, raising change orders as needed
  • Continuously assess project status, reassess and revise risks, oversee issue documentation and escalation, and ensure the project team and stakeholders remain informed of project status, risks, and issues throughout the project (including both periodic project health updates as well as ad hoc communications for emerging impacts)
  • Collaborate with functional leads to identify, evaluate, and communicate project requirements, assign and revise assignment of resources, to interpret and resolve project issues, and to ensure all project objectives and work products are completed
  • Coordinate or execute resourcing change and task progress updates to the project resource management system
  • Coordinate and lead well-organized project meetings, and ensure minutes and action items are distributed
  • Apply general business expertise and/or seek and implement advice from appropriate subject matter experts to make informed decisions that lead to project success
  • Author the clinical systems project plan
  • Review and provide approval for project documents authored by other project team members or vendors, ensuring alignment with project objectives, Worldwide SOPs, and regulatory requirements
  • Ensure all project documentation is filed timely, is complete and accurate, and is signed as appropriate
  • Coordinate and ensure completion of user acceptance testing by appropriate stakeholders as required
  • Coordinate installation and operational qualification where applicable
  • Request, receive and process/upload draft and final subject and kit schedules and inventory release files where required for projects that include study IRT delivery
  • Perform QC checks of manual database edits and other tasks where required
  • Provide oversight and support of assigned ongoing studies, including periodic on-call support when required
  • Provide first-line and second-line support where appropriate to clinical systems supported by the Clinical Systems Department
  • Coordinate the identification, documentation, and management of incidents that occur both within as well as outside of project delivery
  • Attend off-site Investigator Meetings and other types of project related meetings when required
  • Contribute to the identification, creation, and improvement of key performance indicators to identify actionable issues and opportunities for improvement
  • Compile and disseminate KPIs and other project metrics in alignment with project requirements and department standards for project metrics
  • Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
  • Contribute to the identification and implementation of process improvement initiatives
  • Perform other duties as assigned

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

  • Ability to communicate concisely and effectively in both written and spoken English
  • Proficient client-facing skills
  • Proficient in the use of common office software
  • Self-motivated individual who can positively contribute to a team environment
  • High attention to detail
  • Ability to prioritize and handle multiple projects simultaneously
  • Flexible and able to use sound independent judgment and take initiative to assess information
  • Able to make effective decisions in a fast-paced, highly dynamic environment
  • Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems


  • Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
  • Minimum 2 years’ project management experience
  • Minimum of 5 years experience within CRO /pharma environment
  • Experience working in regulated environments such as clinical trials (GAMP, ISO Standards)
  • Contract Research Organization (CRO) or Pharmaceutical experience required
  • Possessing an in-depth understanding of project management expectations and practices with ability to work to and direct project plans
  • Familiar with IRT topics, including IRT study design, randomization methodologies, and just-in-time drug supply
  • Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
  • Proven ability to manage delivery of technology solutions deployed in clinical trials – such as IRT, RTSM, CTMS, EDC or other relevant technologies desired
  • Familiarity with GxP Validation Requirements




Employment Type: Regular

Community / Marketing Title: Clinical Systems Project Manager

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.


CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.

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