Clinical Project Manager " >Clinical Project Manager

Nov 11, 2021

Job Description

145 ! Is the number of colleagues in clinical project management contributing to >100 diverse clinical projects across the entire Novartis organization. Come join this team of multi-cultural, motivated and solution-focused colleagues directly impacting the lives of patients and families. Our CPM organization offers a dynamic and flexible environment to enable you to learn and grow your cross-functional expertise.

Your responsibilities include, but are not limited to:

• Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved or support the Sr. CPM (where applicable).

• Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures.
• Might be required to support or lead other projects/program, in collaboration with cross-functional teams.

• Responsible for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.

• As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard with local regulation requirement.

• As applicable, support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required.

• Also, if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.

• As applicable, responsible for review of all site visit related reports and quality control of monitoring activities in timely manner.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Approximately 8 years’ of Global Clinical Operations experience with managerial experience in designing, planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization.
• Proven ability to work independently in a complex matrix environment (including remote), including leading cross-functional team.
• Solid project management skills. Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
• Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills. Strong customer-oriented mindset.
• Ability to resolve issues with minimal supervision and understand when to escalate. Willingness to act accountably in project/study management.
• Travel internationally/domestically as required.

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Hyderabad, AP
Research & Development
Full Time
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Clinical Project Manager

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