Clinical Operations Specialist Job In The Medicines Company In Hyderabad / Secunderabad, Telangana, India

Job DescriptionJob 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 expertiseYour responsibilities include, but are not limited to: Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers.

Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, under responsibility of COS or CPM as applicable: Update data, timelines, milestones, EC/HA authorizations, etc on an ongoing basis Support (Sr.

) Clinical Project Manager (CPM) with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable Perform Good receipt booking in line with Vendor financial report and study status, as required Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, under responsibility of COS or CPM as applicable Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.

Track clinical service progress, ensure CTMS, TMF and other systems as applicable are up to date, report to colleague/customer as per scope of work Address questions escalate issues or critical findings to project lead (Sr/CPM) Support (Sr.

) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for study start during study conduct and close-out Follow-up with External Service Providers on day-to-day operations Ensure all data is reported to the Clinical Trial Team and available to colleague/customer Logistical support to study team (internal and external) onboarding process.

Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation Support CTT in study start-up activities, recruitment and close-out activities as required Champion the implementation of operational changes and transitions as requiredDiversity & Inclusion / EEO Minimum Requirements Approximately 3-4 years of operational experience of clinical study execution in a pharmaceutical company or contract research organization.

Experience in finance: forecast, actuals, cost reconciliation, a plus Strong technical and organizational skills (Excel, MP,), Details oriented Thorough knowledge of Good Clinical practice.

Demonstrated ability to establish effective working relationship in a matrix and multicultural environment Demonstrated presentation and diplomacy skills Strong customer-oriented mindset.

Willingness to act accountably in project/study management Travel internationally/domestically as requiredWHY NOVARTIS769 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 livesWe 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 serveJoin 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:

The Medicines Company is looking for .

The Medicines Company is looking for Any Graduate / Post Graduate profile candidates.