Clinical Systems Lead
Requisition Number: 6170
Position Title: Clinical Systems Lead
Who we are
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 3,000 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.
SUMMARY: Execute the successful implementation of assigned clinical system 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:
- Act as the functional lead for delivery of one or more clinical system study implementations by:
- Collaborating with the project manager to track and report project status
- Acting as the system subject matter expert for internal as well as client stakeholders
- Collaborating with the project manager to ensure accurate resource management reporting and forecasting
- Leading the effort to deliver the necessary study configuration and documentation within schedule and to a high level of quality and completeness
- Providing periodic demonstrations of system functionality to internal and client stakeholders, capturing and resolving issues and requests for change
- Author clinical system User Requirements Specifications where required
- Perform configuration and study setup to meet study timelines, fulfill business and technical requirements, and align with SOPs
- Perform quality control checks and/or lead or participate in testing efforts for study builds (as required by the system’s SOPs) to ensure study build compliance with requirements and SOPS
- Work closely with applicable Worldwide departments to define and coordinate integration processes between systems/vendors
- Ensure live study implementations are functioning to meet their service level agreements by responding to stakeholder communications, analyzing and resolving issues encountered, and implementing bug fixes where required and in alignment with SOPs
- Author or review study reference materials where required
- Provide training on the use of clinical systems at Investigator and CRA meetings as required per SOP or contract
- Provide study specific training for assigned Worldwide project staff as appropriate
- Identify and report to the project manager any out of scope work
- Provide or assist with the provision of time estimates for study delivery, amendments, change requests, or issue resolution
- Contribute to the identification and implementation of process improvement initiatives
- Assist in the investigation and resolution of issues and/or incidents
- Ensure that all activities are appropriately documented and stored in accordance with the relevant SOP and requirements of the client company
- Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
- 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.
OTHER SKILLS AND ABILITIES:
- Ability to communicate concisely and effectively in both written and spoken English
- Proficient client-facing skills
- Proficient in the use of common office software
- Able to work independently or in a multi-disciplinary team
- High attention to detail
- 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 be able to demonstrate equivalent experience
- 2+ years’ experience in a combination of Contract Research Organization (CRO) experience, CTMS or IRT study delivery, or clinical systems configuration desired
- Experience working in regulated environments such as clinical trials (GAMP, ISO Standards)
- Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
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.
Employment Type: Regular
Community / Marketing Title: Clinical Systems Lead
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.