Study Start-Up Manager

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 leads 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.

Key Responsibilities

• The SSUM is responsible for study planning SSU processes and activation of assigned projects ensuring compliance with Novartis standards GCP / ICH guidelines and regulatory requirements.
• 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 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.

Qualifications

• 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.

Benefits

Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. Learn more about our benefits and rewards in the Novartis Life.

Diversity and Inclusion

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

Other Information

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

Employment Type: Full-Time

Experience: years

Vacancy: 1