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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, leading the internal team, and managing the financial performance of the project. They are expected to have a solid understanding of drug development, clinical trials, CRO operations, ICH GCP, and regulatory requirements, and contribute to process improvement initiatives.

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 and manage project risks.
Set up and maintain operational project plans, timelines, and study tracking tools.
Manage study vendors to ensure adequate study support.
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.
Recognize changes in scope and initiate change orders with Business Development.
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 obtain approvals.
Manage study logistics to ensure sites maintain adequate supplies.
Actively manage subject recruitment to meet study targets and implement strategies to improve site performance.
Review visit reports and ensure trial conduct aligns with protocol, GCP, and regulatory requirements.
Coordinate clinical and data management activities with the Data Management team.
Coordinate safety management activities with the Pharmacovigilance team.
Ensure set up 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.
Assist in the review and development of SOPs and processes.
Identify process inefficiencies and recommend improvements to management.
Participate in project management group activities.
Gather feasibility information as requested, in collaboration 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 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 Management
Budget Management
Vendor Management
Site Management
Subject Recruitment
Regulatory Submissions
GCP Compliance
Risk Management
Process Improvement
Communication
Collaboration
Strategic Thinking
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

Hybrid working arrangements
Full flexibility in working hours
Work-life balance support
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.
Empowers team members through trust, flexibility, and autonomy.
Offers mentorship opportunities, professional development programs, and a dynamic community.
Provides a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
Has advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
Offers a trusted, long-term partnership and an accelerated path to bring life-changing advances to market.
Provides opportunities to develop careers by joining 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 fosters 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.
We are a Circle Back Initiative Employer and commit to respond to every application.