Clinical Operations Manager (Multiple Listings)
Novartis
2 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Provide operational/logistical support to clinical trials (Biomedical Research) with increased complexity/priority status in compliance with Novartis processes and GCP.
- Support the Clinical Trial Team across the study lifecycle via assignments 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/management of clinical/regulatory/study documents (e.g., protocols, patient-facing documents, CSR appendices) ensuring completeness, accuracy, and consistency.
- Support/lead interactions and communications with relevant functions (including country organizations) to collect/compile documents and follow up on pending actions.
- Support/lead external communications (e.g., newsletter development, external meeting organization).
- Ensure accuracy/completeness of clinical trial management databases and systems (e.g., CTMS, Novartis Connect), identify discrepancies, and correct as needed.
- Identify areas for process/technology improvements; support business logistics (access/materials, organizing meetings, signatures).
- Support onboarding/training; may act as SME and represent Study Operations in cross-functional initiatives.
Qualifications (Essential):
- Relevant pharma/biotech/CRO experience with solid understanding of drug development process; early clinical development preferred.
- 1+ years’ experience in early phase clinical trials operations.
- Solid knowledge of site selection and global/country-specific requirements, timelines, and challenges.
Desirable:
- Successful completion of Academy fellowship program.
Compensation/Benefits:
- Salary expected: $108,500–$201,500/year; performance cash incentive and potential annual equity awards. US eligible employees: comprehensive health/life/disability, 401(k) match, and paid time off.
- Provide operational/logistical support to clinical trials (Biomedical Research) with increased complexity/priority status in compliance with Novartis processes and GCP.
- Support the Clinical Trial Team across the study lifecycle via assignments 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/management of clinical/regulatory/study documents (e.g., protocols, patient-facing documents, CSR appendices) ensuring completeness, accuracy, and consistency.
- Support/lead interactions and communications with relevant functions (including country organizations) to collect/compile documents and follow up on pending actions.
- Support/lead external communications (e.g., newsletter development, external meeting organization).
- Ensure accuracy/completeness of clinical trial management databases and systems (e.g., CTMS, Novartis Connect), identify discrepancies, and correct as needed.
- Identify areas for process/technology improvements; support business logistics (access/materials, organizing meetings, signatures).
- Support onboarding/training; may act as SME and represent Study Operations in cross-functional initiatives.
Qualifications (Essential):
- Relevant pharma/biotech/CRO experience with solid understanding of drug development process; early clinical development preferred.
- 1+ years’ experience in early phase clinical trials operations.
- Solid knowledge of site selection and global/country-specific requirements, timelines, and challenges.
Desirable:
- Successful completion of Academy fellowship program.
Compensation/Benefits:
- Salary expected: $108,500–$201,500/year; performance cash incentive and potential annual equity awards. US eligible employees: comprehensive health/life/disability, 401(k) match, and paid time off.