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About the Role

The Project Manager is responsible for planning and managing all contracted responsibilities for assigned projects, acting as the primary contact between Novotech and the client. This role leads and oversees clinical project execution according to regulations, guidelines, and SOPs, ensuring projects are delivered on time and within budget. The Project Manager is accountable for overall project deliverables, leading the internal team, and managing the financial performance of the project. A solid understanding of drug development, clinical trials, CRO operations, ICH GCP, and regulatory requirements is expected, along with contributing to process improvement initiatives.

Responsibilities

Determine project feasibility to assist Business Development.
Provide guidance and review scope of work, responsibilities, timelines, and quality of deliverables.
Ensure Novotech performs services to the required standards as per the Project Agreement.
Understand project risks and collaborate with management on contingencies.
Ensure setup and maintenance of operational project plans, timelines, study tracking tools (CTMS), and eTMF.
Assess, appoint, and manage study vendors with the Vendor Manager.
Manage study budget and revenue according to agreements.
Adjust ongoing revenue forecasts based on study progress.
Ensure the project meets realization and profitability targets.
Communicate changes impacting revenue to management.
Ensure scope changes are recognized by the client and change orders are initiated.
Select and manage investigational sites to meet client objectives and timelines.
Identify and evaluate investigational sites according to study requirements.
Ensure high-quality ethics & regulatory submissions and approvals are obtained.
Manage study logistics to ensure adequate site supplies.
Actively manage subject recruitment, activation, and retention.
Investigate poorly performing sites and propose improvement strategies.
Instigate recruitment initiatives if recruitment is delayed.
Review visit reports and ensure adherence to protocol, GCP, and regulatory requirements.
Ensure consistency of training, monitoring, and study procedures across sites.
Address and escalate site issues as necessary.
Coordinate clinical and data management activities with Data Management.
Coordinate safety management activities with Pharmacovigilance.
Coordinate the Safety Review Committee (SRC) per project scope.
Ensure setup and maintenance of (e) TMF and in-house site files as per SOPs.
Ensure essential documents for site activation are reviewed and approved prior to IP release.
Ensure ongoing maintenance of the (e) TMF throughout the study.
Ensure adherence to Company policies, SOPs, and procedures.
Be quality-minded in performance of duties.
Assist in the review and development of SOPs and processes.
Identify process inefficiencies and recommend improvements to management.
Participate in project management group activities.
Coordinate feasibility information gathering with the Business Development group.
Identify and highlight opportunities within projects to expand business collaborations.
Participate in Bid Defence Meetings as requested.
Ensure all communications and study team performance present a positive professional image of the company.
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’ experience within the clinical research industry.
Previous project management experience, including Associate Project Manager or equivalent.
CRO experience is advantageous.
Full unrestricted working rights in Australia.

Skills

Drug development
Clinical trial process
Clinical Research Organisation (CRO) operations
ICH GCP
International regulatory requirements
Local regulatory requirements
Process improvement

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, including Associate Project Manager or equivalent

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).
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).
Fostering an environment that reflects the life-changing work we do.
Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
Uniting professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
Employees are at the heart of our success.
Offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework.
Empowering team members to create an effective work-life balance.
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.

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.