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 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.

Minimum Qualifications & Experience:

• 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.