Project Specialist - USA
Novotech, South San Francisco, CA, Onsite
Project ManagementBachelor RequiredMid Level
About the role
About the Role
Project Specialist (PS) works collaboratively with the Project Manager (PM) to support project management activities in accordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and the Project Agreement to deliver the project on time and to budget. PS also works in partnership with the PM to mitigate risk and ensure customer satisfaction related to assigned projects. Project Specialist should liaise with the Clinical teams and assist the PM for the delivery of the project from start up through to the Close out phase. Project Specialist is expected to have a sound understanding of the drug development and clinical trial process, ICH GCP, international and local regulatory requirements.
Responsibilities
- Assist the PMs to manage project deliverables, cost control, and risk management activities.
- Ensure set up and ongoing maintenance of operational project plans, timelines and study tracking tools and systems (such as CTMS, eTMF and Financial Force), as required.
- Take a lead role to provide support services to the team on regional studies while coordinating with the regional Clinical Support teams.
- Prepare study templates and share with project teams as needed such as ISF templates, Project Plans and study tools.
- Provide support to the PM on project finances as delegated such as SVT development, vendor invoices review and tracking, review of project level reports, assist with project finance end of month activities (e.g. revenue recognition).
- Responsible for TMF Management on assigned projects including set up, management and reviews plus support project audits as needed.
Experience and Qualifications
- Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.
- Ideally 2-3 years’ experience within the clinical research industry and previous project support experience. CRO experience is advantageous.
About Novotech
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years. For more information or to speak to an expert team member visit www.Novotech-CRO.com