1.Support OTM CTL Manager and CTL’s in group in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of related study documents (eg sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
2. Support CTL’s by setting up and maintaining appropriate study tracking forms including: enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs.
3. Support CTL’s in managing interactions with relevant functions including Drug Supply Management and Novartis local organizations (CPOs). Support CTH with all US drug supply shipping (initial and re-supply) to local CPO and all US sites to ensure timely SIV and uninterrupted patient treatment. Function as the liaison with Fisher to ensure drug delivery and relabeling occur in a timely fashion and track all drug at the central hubs. Support CTL’s in all drug tracking (central hubs, local CPO’s and sites) to ensure adequate supply, monitor expiration dates and assist in relabelling as appropriate. Support CTL in tracking all batch numbers used throughout trials and assist with preparation of appropriate CSR appendix.
4. Manage and track, US invoices for third party vendors working closely with the CTL. Process all US third party vendor payments in Req to Pay (function of NJ CPA’s only). Function as a liaison between third party vendor and Req to Pay to resolve issues and discrepancies, as appropriate.
5. Functions as the local trial leader (LTL) for US operational activities including working closely with US Clinical Operations for US study start up meetings and trial agreements in addition to all other US based study start-up activities working closely with the US Clin Ops Oncology to ensure timely Study Initiations and VDR support; Updates Global ICF templates for all trials to ensure appropriate Novartis US standard language incorporated at time of package release while acting as the US liaison with Novartis Legal and the US sites through IRB approval process.; Is primary contact for the US sites for operational issues.
6. Set up and maintain eTMF tracker in CREDI for all studies. Provide support to CTL to ensure timely completion of eTMF tracker for CSR.
7. Support CTL in delegated aspects of trial data analysis and reporting including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings). Provide support in maintaining CTT membership lists, distribution of meeting agendas, meeting scheduling.
8. Assist CTL with preparation and distribution of study tools needed at study start up and throughout trial as appropriate.
Bachelor degree or equivalent education/degree qualification in life science/healthcare required. At least 1 year of involvement with clinical study planning, execution, reporting or publishing activities (either at a local medical organization, investigational site, pharmaceutical company/CRO, or clinical fellowship program) preferred. Fluent English (oral and written). Good communication, organization and tracking skills. Detail oriented. Some basic knowledge of Good Clinical Practice; basic knowledge of scientific principles
Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.