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 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 team 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).
- Liaise with client/alliance partner team members as delegated by the PM.
- Assist the PM and Project Director (PD) with maintaining project CTMS compliance. Produce and review metrics reports, conduct gap and trend analysis, compliance monitoring, highlighting “red flags” and follow up for resolution.
- Organize and support PM/LCRA to prepare project communications, agenda and presentations comprising of study data for study team meetings (internal and external) and prepare meeting minutes.
- Assist the PM in vendor management activities to ensure delivery to contract as delegated.
- Provide support to the PM in all start up activities of the project such as tracking of submissions/approvals and preparation and review of activation forms and associated documentation.
- Responsible for TMF Management on assigned projects including set up, management and reviews plus support project audits as needed.
- Ensure adherence to Company policies, SOPs and procedures and be quality minded in performance of duties.
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties and performance of the study team, presents a positive professional image of the company.
- 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.
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
Skills Required
- Graduate in a clinical or life sciences related field
- Previous project support experience in clinical research
- Sound understanding of drug development, clinical trial process, ICH GCP, and regulatory requirements
- Experience with CTMS, eTMF, FinancialForce or similar study tracking systems
- TMF management and audit support experience
- Ideally 2-3 years' experience within the clinical research industry
- CRO experience advantageous
What We Do
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, "Novotech" and "PPC". Novotech is a full-service clinical CRO with labs, phase I facilities, and drug development consulting services.
