Job Description

The Clinical Operations Manager (COM) provides line management of a team of Clinical Leads and/or administrative staff and ensures that line reports conduct clinical trials according to all applicable Good Clinical Practice (GCP) guidelines, regulatory requirements, Standard Operating Procedures (SOPs) and the Project Agreement. The COM will support the project teams on operational oversight for clinical activities, as well as responsible for resourcing and staffing, assess performance, mentor, and resolve clinical operational issues.

Responsibilities:

Line Management

• Act as line manager for one or more Clinical Leads and/or administrative staff in collaboration with Human Resources (HR) and senior management, identify resource needs and hire new staff
• Ensure all line reports receive appropriate induction on commencement of employment, and that they understand the company policies and procedures appropriate to their position
• Meet regularly with line reports, and review and manage their work quality, workload, welfare and developmental needs
• Performance management of line reports: set and agree goals and objectives; competency assessments; co-ordinate salary reviews and promotions, and maintain succession plans
• Review and assist with the development and maintenance of clinical operations processes, tools and SOPs
• Review and approve internal expense requests in line with company policy
• Review and approve leave requests in line with company policy.

Learning and Development

• Conduct accompanied monitoring assessments and co-monitoring visits to ensure compliance with SOPs, GCP Guidelines and regulatory requirements as per Novotech guidelines.
• Contribute to the development and delivery of training to Clinical Operations staff.

Business Development

• Represent Novotech at industry conferences and other professional meetings as delegated
• Assist with the conduct of feasibility assessments and provide feasibility information to BD
• Achieve and maintain a good understanding of the local and international clinical trial industry and provide advice to BD
• Identify and highlight opportunities within own projects or with existing clients to expand business collaborations
• Represent Novotech at bid defence meetings and other business development meetings with local and international clients.
• Office and/or Country Management (if applicable)
• Establish and maintain relationships with key clinical trial sites and opinion leaders
• Establish and maintain relationships with local 3rd party vendors (e.g. central laboratories, drug distribution depots, couriers, regulatory consultants, and translators).

General:

• Adhere to Company policies, procedures and guidelines and be quality minded in performance of duties
• Identify areas of inefficiency and make recommendations for improvements
• Assist in the review and development of Novotech SOPs and guidelines
• Participate in activities of the clinical operations group, including coordination of and presentation at clinical team meetings
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry
• Ensure all communications with external parties and the performance of the study
• team presents a positive professional image of the company.

Minimum Qualifications & Experience:

• Graduate in a life sciences related field and/or line management experience within the pharmaceutical industry.
• Experience in a SCRA, PM, or similar role, including considerable monitoring experience.
• CRO experience, line and/or matrix management experience are highly regarded.

The salary range for this position is $135,000 - 170,000 based upon experience.

Novotech is proud to offer a great workplace. 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.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

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. We look forward to contacting you regarding your application.

About Us

Novotech is a global full-service clinical Contract Research Organization (CRO).

At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to 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. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.

At Novotech, our employees are at the heart of our success. By offering 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.

With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.

About the Team

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees 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.

At Novotech you will work alongside empowered teams with a shared commitment to success.

• Strategic vs transactional mindset.

• Ability to gain insights and make proactive decisions quickly.

• Culture that fosters partnership and collaboration, where every voice is heard and valued.

• Ongoing support from senior stakeholders and leadership team.