The Expert Clinical Manager is responsible for operational aspects clinical trials (phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use) under the leadership of Level 3. Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.
Contributes to or manage simple clinical trial with minimal supervision by providing input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare training materials and presentations related to the planning and conduct of the trial.
Recommend, Manage simple clinical trial under supervision from the senior clinical operations team. Write CTT meeting minutes. May deputize for the Level 3 at certain meetings
Ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures and quality standards, SOPs and Business Guidances.
Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.
Assist in preparation of clinical outsourcing specifications. Responsible for management of Contract Research Organizations ( CROs) and ensure adherence to scope of work within timelines and budget
Support the development, management and tracking of trial budget working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc
Participate in the on-boarding and training of new staff. May serve as faculty member for training programs.
Responsible for MRC process as directed by GMA medical lead. Contribute to the management of third-party Investigator Initiated Trials (ITT), Regional and Locally Sponsored Novartis Trials – provide feedback on study proposals, review submitted study concepts/protocols for core requirements via the Study Express System. Collaborate with local CPOs and regions to track study progress, update databases and manage budget. Ensure compliance with Novartis SOPs, Business Guidances and regulatory requirements.
Support Individual Patient Support Program as assigned. Manage physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.
Degree in health or life sciences
= 3 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
Proven ability to work independently and ability to collaborate and work effectively in teams.
Demonstrated ability to support more than one clinical trial
Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required
Basic knowledge of hematology/oncology therapeutic area., is preferred
Novartis is an EEO/AA employer M/F/D/V. This position will be filled at a level commensurate with experience.
About Novartis Oncology :
At Novartis Oncology, our employees worldwide share a common mission: discover and develop innovative medicines to fight cancer. We are passionate about providing a broad range of new remedies and practical solutions that change the way patients live with cancer. In the last five years, Novartis Oncology products have helped improve, extend, and save the lives of more than 2 million people with breast cancer, chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), multiple myeloma, prostate cancer, carcinoid syndrome, and other cancers. With more than 7800 employees operating in over 50 countries, Novartis Oncology has a truly global reach. We have the advantage of extraordinarily talented and globally diverse employees who, through shared goals and different perspectives, are dedicated to improving and extending the lives of patients around the world.
Novartis Awards and Recognition :
- Working Mother’s 100 Best Companies 2012 and 2013
- Barron's World’s Most Respected Companies 2012 (Novartis ranked as the most respected healthcare company)
- Fortune’s World’s Most Admired Companies 2012 and 2013 (Novartis ranked as the most admired pharmaceutical company)