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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-conscious 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 study budgets and revenue, including forecasting and ensuring profitability targets are met.
- Initiate and prepare 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 as needed.
- 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
- Full-time
Experience Level
- At least 5 years experience
- 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
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Ambition meets opportunity at Novotech.
- 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 life-changing work.
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- Unites professionals from diverse backgrounds to advance therapies.
- Employees are at the heart of success.
- Offers trust, flexibility, and autonomy through programs like NovoLife.
- 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.
- Has advanced therapeutic and regulatory expertise.
- Possesses the ability to execute across markets.
- Employs a client-centric service model.
- Provides a trusted, long-term partner and an accelerated path to market.
- Offers employees the opportunity to develop careers in a diverse and supportive global organization with a collaborative culture.
- Works with clients on the cutting-edge of life sciences.
- Works alongside empowered teams with a shared commitment to success.
- Fosters a culture that values partnership and collaboration, where every voice is heard and valued.
- Provides ongoing support from senior stakeholders and leadership team.
Equal Opportunity
- Committed to being an employer of choice for gender equality.
- 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.
- A Circle Back Initiative Employer committed to responding to every application.