Clinical Operations Manager
Novartis
2 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Provide operational and logistical support to clinical trials in Biomedical Research (BR), focusing on increased complexity/priority status, in compliance with Novartis processes and GCP.
- Support the Clinical Trial Team (CTT) across the study lifecycle via study assignment and/or on-demand support.
- Maintain knowledge of ICH-GCP, external regulations, and internal procedures; enhance expertise via Novartis SOPs and internal policies.
- Contribute to finalization and management of clinical/regulatory/study documents (e.g., protocols, patient-facing documents, CSR appendices) to ensure completeness, accuracy, and consistency.
- Support and/or lead cross-functional and external communications (including Novartis country organizations); prepare/compile documents and follow up on pending actions.
- Ensure accuracy and completeness of clinical trial management databases and trial systems (e.g., CTMS, Novartis Connect), identify discrepancies, and ensure timely updates/corrections.
- Identify areas for process/technology improvements.
- Support business logistics (e.g., collection of access/materials, organizing meetings, obtaining signatures).
- Onboard and train others (guidance, training, demos, updates).
- Serve as SME and represent Study Operations in cross-functional/divisional initiatives.
Essential Requirements:
- Relevant pharmaceutical/biotech/CRO drug development experience; solid understanding of the drug development process (early clinical development preferred).
- 1+ years’ experience in early phase clinical trials operations.
- Solid knowledge of clinical trial site selection, global/country requirements, and execution timelines/challenges.
Desirable Requirement:
- Successful completion of an Academy fellowship program.
- Provide operational and logistical support to clinical trials in Biomedical Research (BR), focusing on increased complexity/priority status, in compliance with Novartis processes and GCP.
- Support the Clinical Trial Team (CTT) across the study lifecycle via study assignment and/or on-demand support.
- Maintain knowledge of ICH-GCP, external regulations, and internal procedures; enhance expertise via Novartis SOPs and internal policies.
- Contribute to finalization and management of clinical/regulatory/study documents (e.g., protocols, patient-facing documents, CSR appendices) to ensure completeness, accuracy, and consistency.
- Support and/or lead cross-functional and external communications (including Novartis country organizations); prepare/compile documents and follow up on pending actions.
- Ensure accuracy and completeness of clinical trial management databases and trial systems (e.g., CTMS, Novartis Connect), identify discrepancies, and ensure timely updates/corrections.
- Identify areas for process/technology improvements.
- Support business logistics (e.g., collection of access/materials, organizing meetings, obtaining signatures).
- Onboard and train others (guidance, training, demos, updates).
- Serve as SME and represent Study Operations in cross-functional/divisional initiatives.
Essential Requirements:
- Relevant pharmaceutical/biotech/CRO drug development experience; solid understanding of the drug development process (early clinical development preferred).
- 1+ years’ experience in early phase clinical trials operations.
- Solid knowledge of clinical trial site selection, global/country requirements, and execution timelines/challenges.
Desirable Requirement:
- Successful completion of an Academy fellowship program.