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About the Role

The Project Manager is responsible for the planning and management of all contracted responsibilities for assigned projects, acting as the primary contact between Novotech and the client. This role leads and oversees the execution of clinical projects in accordance with regulations, guidelines, and SOPs to ensure timely and budget-compliant delivery. The Project Manager is accountable for overall project deliverables, internal team leadership, and financial performance.

Responsibilities

Determine project feasibility and provide guidance on scope of work, timelines, and quality.
Ensure adherence to the Project Agreement and manage project risks.
Set up and maintain operational project plans, timelines, and study tracking tools.
Assess, appoint, and manage study vendors in collaboration with the Vendor Manager.
Manage the study budget and revenue, including forecasting and ensuring profitability targets are met.
Initiate change orders for scope adjustments.
Select and manage investigational sites to meet client objectives and timelines.
Oversee ethics and regulatory submissions and approvals.
Manage study logistics and ensure adequate site supplies.
Actively manage subject recruitment and retention, implementing initiatives to improve site performance.
Review visit reports and ensure compliance with protocols, GCP, and regulatory requirements.
Coordinate clinical and data management activities with relevant teams.
Coordinate safety management activities and potentially the Safety Review Committee.
Ensure setup and maintenance of TMF and site files according to SOPs.
Ensure adherence to Company policies, SOPs, and procedures.
Assist in the review and development of SOPs and processes.
Participate in the project management group activities.
Coordinate feasibility information gathering with the Business Development group.
Identify opportunities to expand business collaborations within own projects.
Participate in Bid Defence Meetings as requested.
Represent Novotech professionally in all external communications and study team performance.
Represent Novotech at industry forums.

Requirements

Graduate in a clinical or life sciences related field.
Relevant experience/qualifications in allied professions may be considered.
At least 5 years of experience within the clinical research industry.
Previous project management experience, including Associate Project Manager or equivalent.
CRO experience is advantageous.
Must have full unrestricted working rights in Australia.
Cannot provide sponsorship for this role.

Skills

Drug development and clinical trial process understanding
Clinical Research Organisation (CRO) operations understanding
ICH GCP knowledge
International and local regulatory requirements knowledge
Process improvement
Strategic mindset
Ability to gain insights and make proactive decisions quickly
Partnership and collaboration
Communication

Location

Australia

Work Type

Hybrid working arrangements
Flexible working hours

Experience Level

At least 5 years’ experience within the clinical research industry
Previous project management experience

Education Level

Graduate in a clinical or life sciences related field

Benefits

Flexible working options
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development programs
NovoLife (flexible benefits framework)

About the Company

Novotech is a global full-service clinical Contract Research Organization (CRO).
Novotech is a globally recognized leader in clinical research and scientific advisory services.
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).
Committed to fostering an environment that reflects the life-changing work they do.
Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
Unites professionals from diverse backgrounds and disciplines to advance therapies.
Employees are at the heart of their success.
Offers trust, flexibility, and autonomy.
Empowers team members to create an effective work-life balance.
Provides access to mentorship opportunities, professional development programs, and a dynamic community.
Offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
Advanced therapeutic and regulatory expertise.
Ability to execute across markets.
Client-centric service model.
Trusted, long-term partner.
Accelerated path to bring life-changing advances to market.
Opportunity to develop careers by joining a diverse and supportive global organization with a collaborative culture.
Working with clients on the cutting-edge of life sciences.
Empowered teams with a shared commitment to success.
Culture that fosters partnership and collaboration, where every voice is heard and valued.
Ongoing support from senior stakeholders and leadership team.

Equal Opportunity

Committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Looking for people who identify as LGBTIQ+, have a disability or have caring responsibilities.
Circle Back Initiative Employer and commit to respond to every application.