Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Project Manager plans and manages contracted responsibilities for assigned clinical projects, acting as the primary contact between Novotech and the client. This role oversees project execution in accordance with local regulations, ICH GCP guidelines, and SOPs to ensure delivery on time and within budget. Responsibilities include leading internal teams, managing financial performance, and overseeing the project lifecycle from site selection to study close-out.

Responsibilities

Determine project feasibility to assist Business Development.
Provide guidance and review scope of work, responsibilities, timelines, and deliverable quality.
Ensure Novotech performs services according to the Project Agreement and manage project risks.
Set up and maintain operational project plans, timelines, study tracking tools, and eTMF.
Appoint and manage study vendors such as central laboratories and IRT providers.
Manage study budgets, revenue, and profitability targets.
Initiate change orders in collaboration with Business Development when scope changes occur.
Identify, evaluate, and manage investigational sites.
Coordinate with Clinical Operations and Regulatory teams to secure ethics and regulatory approvals.
Manage study logistics and site supplies.
Actively manage subject recruitment and retention strategies.
Review visit reports and ensure trial conduct adheres to protocol, GCP, and regulatory requirements.
Coordinate clinical, data management, and safety management activities.
Ensure maintenance of TMF and in-house site files.
Adhere to company policies and contribute to SOP development and process improvement.
Participate in project management group activities and Bid Defence Meetings.
Represent Novotech at industry forums and professional associations.

Requirements

Graduate degree in a clinical or life sciences related field.
At least 5 years of experience in the clinical research industry.
Previous project management experience, including Associate Project Manager or equivalent.
Full unrestricted working rights in Australia.

Skills

Clinical trial process knowledge
Drug development understanding
ICH GCP guidelines
Regulatory requirements knowledge
Financial management
Risk management
Strategic thinking
Vendor management

Location

Australia

Work Type

Hybrid
Full-time

Experience Level

At least 5 years of experience

Education Level

Graduate degree in a clinical or life sciences related field

Benefits

Hybrid working arrangements
Flexible working hours
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development and mentorship programs

About the Company

Novotech is a global full-service clinical Contract Research Organization (CRO) established in 1997.
The company operates 30+ offices across Asia-Pacific, the United States, and Europe.
Recognized as an Employer of Choice, Great Place to Work, and Employer of Choice for Gender Equality.

Equal Opportunity

Committed to being an employer of choice for gender equality and providing an inclusive work environment.
Encourages applications from people who identify as LGBTIQ+, have a disability, or have caring responsibilities.