Project Specialist

Novotech; United States; On-site; USD 28,000 - 35,000; Full time

Job summary

Novotech is seeking a proactive Project Specialist to support the Project Manager in delivering clinical research projects on time, within budget, and to quality standards. You will help manage study start-up through close-out and collaborate with Clinical teams and vendors.

This role requires 2–3 years in clinical research, understanding of ICH-GCP, regulatory requirements, and strong organizational skills. The candidate will contribute to risk mitigation and client satisfaction.

Qualifications

• Degree in Clinical, Life Sciences or related field.
• 2–3 years in clinical research with project support experience.
• CRO experience is advantageous.
• Knowledge of ICH‑GCP, regulatory requirements.
• Strong organisational and time-management skills.
• Attention to detail and quality mindset.
• Good communication and stakeholder management.
• Ability to work independently with PM and wider clinical teams.
• Proactive, solutions-focused approach to issues.
• Commitment to high-quality work and client satisfaction.

Responsibilities

• Support PM in managing deliverables, timelines, cost control and risk management.
• Set up and maintain project plans and study tracking tools (CTMS, eTMF, FinancialForce).
• Provide project support for regional studies with Clinical Support teams.
• Prepare study templates and project tools (ISF templates, Project Plans).
• Assist PM with financial activities and revenue recognition.
• Liaise with clients, alliance partners and internal stakeholders.
• Support CTMS compliance, metrics reporting and trend analysis.
• Coordinate study team meetings and document minutes.
• Assist vendor management ensuring alignment with contracts.
• Support start-up activities including regulatory submissions and activation forms.
• Take responsibility for TMF management and audits.
• Ensure compliance with SOPs and quality standards.
• Identify risks and escalate to PM.
• Maintain professional communication with stakeholders.
• Undertake additional project-related responsibilities.

Skills

Project coordination

Stakeholder management

Risk management

Communication

Organisational skills

Independent working

Education

Degree in Clinical/Life Sciences or related field

Tools

CTMS

eTMF

FinancialForce

Job description

The Project Specialist (PS) works collaboratively with the Project Manager (PM) to support the successful delivery of clinical research projects in accordance with local regulations, ICH-GCP guidelines, Novotech and client SOPs, and the Project Agreement. Working closely with the PM and Clinical teams, the Project Specialist supports project delivery from study start‑up through to close‑out, helping ensure projects are delivered on time, within budget and to the required quality standards. The PS also plays an important role in risk mitigation, compliance monitoring and customer satisfaction, providing proactive operational support across assigned projects. The ideal candidate will have a sound understanding of the drug development and clinical trial process, ICH‑GCP and relevant international and local regulatory requirements, together with strong organisational and communication skills.

About the Role

The Project Specialist (PS) works collaboratively with the Project Manager (PM) to support the successful delivery of clinical research projects in accordance with local regulations, ICH‑GCP guidelines, Novotech and client SOPs, and the Project Agreement. Working closely with the PM and Clinical teams, the Project Specialist supports project delivery from study start‑up through to close‑out, helping ensure projects are delivered on time, within budget and to the required quality standards. The PS also plays an important role in risk mitigation, compliance monitoring and customer satisfaction, providing proactive operational support across assigned projects. The ideal candidate will have a sound understanding of the drug development and clinical trial process, ICH‑GCP and relevant international and local regulatory requirements, together with strong organisational and communication skills.

Key Responsibilities

• Support the PM in managing project deliverables, timelines, cost control and risk management activities.
• Set up and maintain operational project plans, timelines and study tracking tools and systems, including CTMS, eTMF and FinancialForce.
• Provide project support for regional studies, coordinating activities with regional Clinical Support teams.
• Prepare and maintain study templates and project tools, including ISF templates, Project Plans and other study documentation.
• Support the PM with project financial activities, including SVT development, vendor invoice review and tracking, project‑level reporting and month‑end activities such as revenue recognition.
• Liaise with clients, alliance partners and internal stakeholders as delegated by the PM.
• Support the PM and Project Director with CTMS compliance, including metrics reporting, gap and trend analysis, compliance monitoring and identification and follow‑up of potential issues.
• Coordinate and support study team meetings, including preparation of agendas, communications, presentations and meeting minutes.
• Assist the PM with vendor management activities, ensuring delivery is aligned with contractual requirements.
• Support study start‑up activities, including tracking regulatory submissions and approvals and preparing/reviewing activation forms and related documentation.
• Take responsibility for TMF management on assigned projects, including TMF set‑up, ongoing maintenance, quality reviews and audit support.
• Ensure project activities are conducted in accordance with company policies, SOPs, procedures and quality standards.
• Proactively identify and escalation risks, issues and potential delays to the PM and relevant project stakeholders.
• Maintain professional and effective communication with clients, vendors, investigators and internal teams, representing Novotech positively at all times.
• Undertake additional project‑related responsibilities as assigned by the Line Manager or Project Manager.

About You

We are looking for a proactive and organised professional who can effectively support multiple project activities and work collaboratively with cross‑functional teams.

• A degree in Clinical, Life Sciences or a related field. Relevant qualifications or experience in allied professions may also be considered.
• 2-3 years of experience within the clinical research industry, ideally with previous project support experience.
• CRO experience is advantageous.
• Good understanding of clinical trial processes, drug development and ICH‑GCP.
• Awareness of international and local clinical research regulatory requirements.
• Strong organisational and time‑management skills, with the ability to manage multiple priorities.
• Strong attention to detail and a quality‑focused mindset.
• Good communication and stakeholder management skills.
• Ability to work independently while collaborating effectively with Project Managers and wider Clinical teams.
• A proactive, solutions‑focused approach to identifying and resolving project issues.
• Strong commitment to delivering high‑quality work and supporting successful project outcomes and client satisfaction.

Why Join Novotech?

At Novotech, you will have the opportunity to work alongside experienced clinical research professionals within a global, collaborative and supportive environment.

The Project Specialist role provides excellent exposure to the full clinical trial lifecycle and the opportunity to develop your career in project management and clinical operations while working with innovative pharmaceutical and biotechnology companies.

About Novotech

Novotech is a global full‑service Contract Research Organization (CRO) providing clinical research and scientific advisory services to the biotechnology and pharmaceutical industries.

Since 1997, we have expanded our global footprint to 30+ offices across Asia‑Pacific, the United States and Europe. Our diverse teams work together to advance therapies that improve patient outcomes worldwide.

At Novotech, ambition meets opportunity. We combine advanced therapeutic and regulatory expertise with a client‑centric service model, giving our employees the opportunity to work with innovative life sciences companies and develop their careers within a supportive global organisation.

Our culture is built around:

• Strategic thinking and a proactive mindset
• Partnership and collaboration
• Empowered teams and shared accountability
• Open communication where every voice is heard and valued
• Ongoing support from senior stakeholders and leadership

Join Novotech and be part of a team helping bring life‑changing therapies to patients faster.

Salary Band - Project Specialist - 28,000 - 35,000 euros, Salary offered will be based on the candidate's experience level.

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

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