Project Specialist

Novotech; Philippines; On-site; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Diversity & inclusion

Job summary

Novotech Philippines is seeking a Project Specialist to support project management activities and collaborate with the Project Manager to ensure on-time delivery and budget adherence. The role involves working with clinical teams and coordinating with regional support to meet regulatory requirements.

The ideal candidate will have a life sciences background and 2–3 years in clinical research, with experience in CTMS/eTMF systems.

Qualifications

• Graduate in a clinical or life sciences field.
• Ideally 2–3 years’ experience in the clinical research industry.
• CRO experience is advantageous.

Responsibilities

• Assist PMs to manage project deliverables, cost control and risk management.
• Maintain operational project plans, timelines, and study tracking tools (CTMS, eTMF).
• Lead regional study support and coordinate with regional Clinical Support teams.
• Prepare study templates and templates like ISF, Project Plans, and tools.
• Support project finances: SVT development, invoices review, monthly revenue recognition.
• Coordinate with client/alliance partner teams.
• Ensure CTMS compliance and produce metrics reports.
• Prepare communications, agendas, and presentations for study team meetings.
• Support start-up activities: submissions/approvals, activation forms.
• TMF management on assigned projects; support audits.
• Adhere to company policies and maintain professional image.

Skills

Project coordination

Risk management

Regulatory knowledge (ICH GCP)

Team collaboration

Client liaison

Education

Bachelor’s degree in clinical or life sciences

Tools

CTMS

eTMF

Financial Force

Job description

Project Specialist

Company : Novotech
Job Type : Full Time
Philippines
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Job Description - Project Specialist

Description

Brief Position Description:

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.

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.

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.

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.