Dave Davis, Mba Email & Phone Number

United States

United States

United States

Accountable for providing management of the cross-divisional project team deliverables required to implement the corporate data sharing position. Work collaboratively with the Clinical Study Data Request (CSDR) Consortium Pharma Data Sharing colleagues in the execution of multi-sponsor external research agreements. Assume the lead role whendesignated in executing cross company multi-sponsor agreements. Identify efficiencies and participate in process and system improvement for corporate cross divisional data sharing and the Clinical Study Data Request consortium.Interact with legal, stats/programming, medical writing, regulatory within NIBR, Oncology, General Medicines, Alcon, Sandoz to create and manage the cross divisional program plans of activities and milestones to assure provision of quality and timely deliverables to successfully execute the corporate data sharing position.Work collaboratively with the legal function in preparing external researcher Data Sharing Agreements, tracking the data sharing agreements and final execution to release controlled access to the data sharing deliverables for external research requests

-Ensure all global clinical trial transparency deliverables are met according to quality standards, and operational processes. Maintained 100% compliance with all deliverables across Neuroscience and Ophthalmology franchises -Clinical study assessment of eligibility for results disclosure, CSR review for alignment with results disclosure to the public domain. Analysis and writing of results documents, collaboration with clinical, legal and executive teams to ensure timely disclosure of results. Address and resolve transparency questions received from the therapy areas and country registries.-Conduct compliance monitoring by communicating compliance of clinical trial and results registries against Novartis policies to appropriate leadership. Follow-up to a timely completion all relevant compliance findings. -Compile and report monthly metrics for Clinical Study Report (CSR), Safety Review, Third Party Study Report (TPSR) completion, Novartis Clinical Trials Results Database, CliniclaTrials.gov protocol and results posting data for the QCSP KQI metric analysis. -Support internal and or external audits by managing external & internal audit documentation. Create, track, report and follow-up to a timely completion of audit findings.-Author and reviewer of Standard Operating Procedures associated with the Clinical Disclosure Office

-Maintain solid understanding of regulatory requirements for registering clinical trials and results.-Develop compliance monitoring process for Novartis Pharmaceuticals and communicate compliance of clinical trial and results registries against Novartis policies to appropriate leadership teams.-Ensure organizational knowledge and sustainable compliance to global clinical transparency regulations and policy within General Medicines and Oncology (Global, Medical Affairs, Translational Medicines). Participate in process redesign sessions and rewriting of Standard Operating Procedures. -Develop, organize and conduct training sessions associated with the registering of clinical trial to Novartis Pharmaceutical associates.-Assist in the development of internal and external long term audit plans-Demonstrate capability to independently interpret, discuss and ensure appropriate trial data is accurately represented in clinical registries. Address and resolve transparency questions received from the therapy areas and country registries.

-Database, assess, and processing of all serious and non-serious medical reports into the Global Argus Database.-Review and medically evaluate relevant Drug Safety data while alerting Medical Safety Experts (MSE) of potential serious case assessments and/or trends.-Perform medical and product coding of adverse events with the MedDRA and WHO dictionaries.-Maintain both paper and electronic documents maintained in all applications and case files according to SOP and departmental conventions.-Assist in the development of SOPs, working procedures, Drug Safety conventions and relevant product information.-Support in literature searches for medical inquiries.-QC of cases processed by Drug Safety Associates and Drug Safety Scientists

-Served as Principal Investigator on study protocols and fulfilled all associated responsibilities. Conformed to all SOPs, GLPs, and Novartis safety regulations. Provided input in writing protocols and reporting of study data.-Served as Back-up Supervisor and Trainer/Mentor for new personnel.-Performed all the technical procedures necessary to implement and conduct study protocols for safety evaluation studies with minimal supervision (e.g., handled, dosed, weighed, and fed laboratory animals, observed the effects of test materials under investigation, obtained physiological specimens and measurements, collected, verified, and maintained study data).-Prepared raw data books for archiving. Responded to questions posed by the FDA/EPA auditors during inspections. Identified and corrected data problems. Employed scientific knowledge to develop new or improved methodologies/techniques. Drafted new SOPs or revised existing SOPs as needed.-Competence in the use of all laboratory instrumentation and computer applications. Troubleshooter of equipment problems with minimal supervision. Assisted in the maintenance of laboratory inventories and equipment. Accurately ran all computer-generated reports and prepared tables required for final reports.

Represent Novartis' Clinical Trial Data Sharing initiative at Clinical Study Data Request (CSDR).

Mba, Management

Bs, Business

Certificate, Clinical Research Program

Associates, Biology