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Clinical Project Manager

8 - 12 years

0 Lacs

Posted:4 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

This role is responsible for leading and managing a multidisciplinary cross-functional Clinical Trial Team (CTT) or supporting the Sr. CPM in effective planning, re-evaluation, and implementation of assigned clinical studies and programs. The main focus is on ensuring adherence to timelines, budget, quality standards, and operational procedures as per Novartis Global processes. Key Responsibilities: - Agreeing with colleague/customer team and Line Functions on realistic project and study timelines and escalating issues if no agreement is achieved. - Leading and managing a multidisciplinary cross-functional Clinical Trial Team in planning, re-evaluation, and implementation of clinical studies and programs. - Supporting or leading other projects/programs in collaboration with cross-functional teams. - Organizing investigators meetings and internal meetings related to clinical study execution and operational excellence. - Interacting with investigator sites, CRAs/CROs/vendors to ensure smooth study set up and conduct, reviewing site performance, protocol deviations, risk assessment, and issue resolution. - Supporting compilation of study regulatory documents for submissions to authorities and ethics committees. - Supporting clinical studies with monitoring activities, communications, and quality control of monitoring activities. Essential Requirements: - Approximately 8 years of Global Clinical Operations experience with managerial experience in designing, planning, executing, reporting, and publishing clinical studies. - Proven ability to work independently in a complex matrix environment and lead cross-functional teams. Desirable Requirements: - Solid project management skills. - Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development. - Demonstrated presentation, diplomacy, negotiation, conflict resolution skills. - Strong customer-oriented mindset and willingness to act accountably in project/study management. Novartis is committed to diversity and inclusion in the work environment and building diverse teams that represent the patients and communities served. Join our Novartis Network to stay connected and learn about suitable career opportunities as they arise.,

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