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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. They must identify and mitigate risks, possess a strong understanding of drug development, clinical trials, CRO operations, ICH GCP, and regulatory requirements, and contribute to process improvement initiatives.

Responsibilities

Determine project feasibility and provide guidance on scope of work, timelines, and deliverables.
Ensure Novotech performs services to required standards 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 budget and revenue, adjust forecasts, and ensure profitability targets are met.
Communicate changes impacting revenue and initiate change orders for scope adjustments.
Select and manage investigational sites to meet client objectives and timelines.
Ensure high-quality ethics and regulatory submissions and obtain approvals.
Manage study logistics to ensure adequate site supplies.
Actively manage subject recruitment and retention, investigating and proposing strategies for improvement.
Review visit reports to ensure protocol adherence, GCP compliance, and consistency across sites.
Coordinate clinical and data management activities with relevant teams.
Coordinate safety management activities with relevant teams.
Ensure set up and maintenance of TMF and in-house site files.
Ensure adherence to Company policies, SOPs, and procedures.
Assist in the review and development of SOPs and processes.
Participate in 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 positively 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 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
Risk Management
Budget Management
Vendor Management
Site Management
Subject Recruitment
Data Management Coordination
Pharmacovigilance Coordination
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
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development programs
Flexible benefits framework (NovoLife)

About the Company

Novotech is a global full-service clinical Contract Research Organization (CRO).
Novotech combines a 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).
Fosters 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 to advance therapies.
Empowers team members through trust, flexibility, and autonomy.
Offers mentorship opportunities, professional development programs, and a dynamic community.
Provides advanced therapeutic and regulatory expertise, execution across markets, and a client-centric service model.
Offers a collaborative culture where every voice is heard and valued.
Provides ongoing support from senior stakeholders and the 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.
Circle Back Initiative Employer committed to responding to every application.