Study Start-Up Manager

Healthcare Businesswomen’s Association; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company in Dublin seeks an experienced SSO Study Start-Up Manager to lead local Study Start-Up teams. In this role, you'll manage trial operations, ensuring timely completion of startup activities while collaborating with various stakeholders. The ideal candidate has over 5 years in clinical operations and a degree in a scientific discipline. This dynamic position offers the chance to contribute to the advancement of innovative therapies in a mission-driven environment.

Qualifications

• Minimum of 5 years' experience in clinical operations in a project management role and/or in monitoring clinical trials.
• Understanding of all aspects of clinical drug development, with a specific emphasis on trial set-up.
• Proven problem-solving skills and ability to handle complex issues.

Responsibilities

• Steering all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager.
• Responsible for timely startup activities from country allocation to the Green Light stage.
• Ensuring efficient startup activities, including overseeing submission packages and consent form reviews.

Skills

Budget Management

Clinical Trials

Negotiation Skills

Process Improvement

Project Planning

Vendor Management

Waterfall Model

Education

Degree in a scientific/healthcare discipline

Job description

Job Description Summary

Novartis seeks a dynamic and experienced SSO Study Start-Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start-Up (SSU) Team Lead, and lead the local Study Start-Up teams for designated trials, holding significant responsibilities within our organization, ranging from trial and budget planning to ensuring on-schedule completion of trial start-up activities. As the SSO Study Start-Up Manager, you play an integral role in ensuring that all trial start-up deadlines and results align with our commitments.

Job Description

Key responsibilities

• Steering all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager, SSO Site Partnership Manager, and the global study team.
• Backing the country's SSU strategy, working closely with the SSO Study Start-Up Team Lead, SSO SSU Country Head, and SSO Country Head Portfolio (Early & Late Stage).
• Collaborating with the SSO Country Head Portfolio, SSO Portfolio Team Leads, and the global study team to ensure the SSU schedules and results meet country commitments.
• Responsible for timely startup activities from country allocation to the Green Light stage (ready to initiate site) in assigned projects.
• Facilitating close collaboration with local IRBs/IECs and Health Authorities, where necessary.
• Ensuring efficient startup activities, including overseeing the preparation of initial/amendments submission packages and consent form reviews.
• Coordinating timely responses to deficiency letters working closely with local and global partners.
• Responsible for the timely, accurate, and high-quality country TMF documents, ensuring readiness for inspection, while adhering to financial standards, prevailing legislation, ICH/GCP guidelines, local/National Health Authorities regulations, and Novartis' standards.

Essential requirements

• A degree in a scientific/healthcare discipline with experience in clinical operations or project management.
• Minimum of 5 years' experience in clinical operations in a project management role, and/or in monitoring clinical trials.
• Skilled in leading in a matrix environment, without direct reports.
• Understanding of all aspects of clinical drug development, with a specific emphasis on trial set‑up, execution, and monitoring.
• Proven problem‑solving skills and ability to handle complex issues.
• Understanding of the international aspects of the drug development process, including solid knowledge of international standards (GCP/ICH), Health Authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis' standards.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You will receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model