Project Specialist - USA

Novotech; Durham (NC); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Flexible working options

Job summary

Novotech is seeking a Project Specialist in the Durham area to support the Project Manager in delivering projects on time and within budget, adhering to local regulations and ICH GCP guidelines. The role involves collaboration with Clinical teams and managing startup through close-out phases with a solid understanding of drug development.

The position requires 2–3 years in clinical research, exposure to PM activities, and experience with CTMS/eTMF systems.

Qualifications

• Graduate in a clinical or life sciences field; relevant allied qualifications may be considered.
• Ideally 2–3 years' experience in clinical research and prior project support; CRO experience advantageous.

Responsibilities

• Assist PMs to manage project deliverables, cost control, and risk management.
• Ensure up-to-date operational project plans, timelines, and study tracking tools (CTMS, eTMF, Financial Force).
• Lead regional study support and coordinate with regional Clinical Support teams.
• Prepare study templates such as ISF templates, Project Plans and study tools.
• Support project finances (SVT development, vendor invoices review, revenue recognition).
• Responsible for TMF management, audits support on assigned projects.

Education

Clinical or life sciences degree

Tools

CTMS

eTMF

Financial Force

Job description

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.

Salary Band - Project Specialist: $70,000 USD to $80,000 USD - Salary offered will be based on candidates experience level.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.