Clinical Operations Manager

Novartis•Cambridge, MA

1d•$108,500 - $201,500•Hybrid

About The Position

The Clinical Operations Manager provides clinical leadership and strategic input for all clinical deliverables across assigned projects and programs within BR/TM. Focused on Clinical Pharmacology (CP) portfolio of early phase and submission-enabling profiling clinical trials for Novartis.

Requirements

Relevant experience in pharmaceutical industry /biotech /CRO drug development environment with a solid understanding of drug development process, and early clinical development preferred
1+ years' experience in early phase clinical trials operations
Solid knowledge of clinical trials site selection, global /country specific requirements, timelines and challenges in clinical trial execution process

Nice To Haves

Successful completion of Academy fellowship program

Responsibilities

Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).
Perform defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
Maintain and share up to date knowledge of ICH-GCP, external regulations, and internal procedures.
Continuously enhance expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
Contribute to the finalization and management of clinical, regulatory and study-related documents in scope of role such as study protocols, patient-facing documents, etc., by ensuring documents are complete, accurate, and consistent.
Contribute and/or maintain ownership of the management and finalization of clinical, regulatory, and study-related documents such as study protocols, patient-facing documents, Clinical Study Report (CSR) appendices, etc., by providing support to draft, review, and ensure completeness, accuracy, and consistency of these documents, as needed.
Support and/or lead interactions and communications with relevant functions including Novartis country organizations to prepare, collect, and/or compile relevant documents, and timely follow-up on pending actions as necessary.
Support and/or lead external communication such as newsletter development, external meeting organization.
Contribute to and / or may oversee other study operations support activities (e.g. on-demand operations support, Trial Master File metrics).
Ensure accuracy and completeness of clinical trial management databases, and trial related systems (e.g. Clinical Trial Management System, Novartis Connect), providing information, timely updates and inputs, and follow up on questions as necessary.
Help check for or proactively identify discrepancies and take actions to correct as necessary.
Identify, contribute and/or lead areas for process or technology improvements regarding activities undertaken within the role.
Support and/or lead business logistics through the collection or collation of clinical trial supportive systems access and materials in scope of role (e.g. clinical trial application, end of trial, organizing external meetings, following up required signatures).
Support and/or own onboarding and training others (associates, peers, new starters) by providing on-the-job guidance, training, demo, updates, etc. for assigned mentees or for the community.
May function as Subject Matter Expert (SME) in the areas of expertise.
May represent Study Operations in cross-functional and divisional initiatives and workstreams on area(s) of expertise (e.g. process SME).