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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 project execution according to regulations, guidelines, and SOPs to ensure timely and budget-compliant delivery. The Project Manager is accountable for overall project deliverables, leading the internal team, and managing the project's financial performance.

Responsibilities

Determine project feasibility, considering sponsor needs 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 appropriate contingencies.
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 according to the Master Services Agreement and Project Agreement.
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 and regulatory submissions and approvals are obtained.
Manage study logistics to ensure adequate site supplies.
Actively manage subject recruitment and retention to meet study targets.
Investigate poorly performing sites and propose improvement strategies.
Review visit reports and ensure adherence to protocol, GCP, and regulatory requirements.
Ensure all site issues are addressed and escalated 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.
Ensure ongoing maintenance of the (e)TMF throughout the study.
Ensure adherence to Company policies, SOPs, and procedures.
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.
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 also 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.

Skills

Project Management
Clinical Trial Process
Drug Development
ICH GCP
Regulatory Requirements
Process Improvement
Risk Management
Vendor Management
Budget Management
Site Selection
Subject Recruitment
Data Management Coordination
Pharmacovigilance Coordination
TMF Management
Communication
Collaboration
Strategic Mindset
Proactive Decision Making

Location

Remote
Hybrid

Work Type

Hybrid
Full-time

Experience Level

5+ years experience in clinical research
Previous project management experience

Education Level

Graduate degree in a clinical or life sciences related field

Benefits

Flexible working hours
Work-life balance support
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development programs
Mentorship opportunities
Professional 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.
We combine our position at the forefront of the industry with an 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).
We are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe.
Our growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
Employees are at the heart of our success.
We offer trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework.
We empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
We have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
We provide a trusted, long-term partner and an accelerated path to bring life-changing advances to market.
Employees have the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
We have 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

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.
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.