About the role

Aplyr's Quick Take

This role is about managing the start-up phase of clinical studies, ensuring all activities are completed on time and in compliance with regulations. It's primarily an individual contributor role that involves coordinating with various stakeholders, including local regulatory bodies and the global study team.

Good fit

Ideal candidates have a background in clinical operations or project management, with several years of experience in clinical trials. They should be comfortable working independently in a matrix environment and have strong organizational skills.

Worth noting

The position requires a scientific or health-related degree, and an advanced degree is preferred. The role also involves significant interaction with regulatory authorities, which may be a unique aspect for those looking to deepen their regulatory knowledge.

Job Description Summary

The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager.

Job Description

Key responsibilities but not limited to:

Support country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio.
Collaborate with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments.
Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects.
Ensure close collaboration with local IRBs/IECs and Health Authorities as applicable.
Ensure that study start-up activities are conducted and completed on time, including preparation and review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required.
Prepare and finalises local submission package for submission to IRB/IEC, CTA Hub (Europe: according to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs).
Coordinate timely response to deficiency letters in close collaboration with local and global stakeholders.
Coordinate reportable events and notifications to IRB/IEC and Health Authorities, e.g. substantial and non-substantial amendments, IB updates, ICF updates as applicable, including preparation, update, and review of submission documents.
Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness.

Essential criteria:

A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
Strong experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports
Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring

Desirable criteria:

Strong interpersonal, negotiation and conflict resolution skills.
Communicates effectively in a local/global matrixed environment.

Skills Desired

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

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.