Brad Bitzer Email & Phone Number

Whippany, Nj

Leverkusen, North Rhine-Westphalia, De

• Member of the Risk Based Quality Management (RBQM) Team tasked with defining and implementing cross-functional methods aimed at maximizing operational efficiencies which ensure patient safety whilst delivering high quality fit-for-purpose data required for analysis and submission. Ensure all internal and external regulations are followed e.g. CFR, ICH-GCP, SOPs, processes etc.• Organizational process owner of the Integrated Data Review Plan (IDRP) including its cross-functional implementation levering expertise within: Data Management, Site Management, Medical Experts, Statistics, Medical Writing and Central Data Review (CDR). This includes: all aspects of global trainings, creation and maintenance of all related quality system documentation and full ownership in ensuring continuous process improvement respectively.• Actively manage and develop direct reports located in: UK, Canada, Finland and US within Clinical Data Management. Accountable for all aspects of training, performance management, including annual performance planning, development dialogs, on-going progress review, feedback and performance evaluation based on input from Global Clinical Team and Study Team members, peers within Global Data Sciences & Analytics and other relevant interfacing functions.• Ensure projects/studies are resourced appropriately. • Proactively support and implement process improvements for operational activities where necessary.• Increase efficiencies within Global Clinical Development in close collaboration with other global functions, e.g. measuring against internal and external key performance indicators (KPIs) in order to ensure continuous organizational improvements. • Manage internal cost of up to 1.5 Mio. €, including resource, travel and training requirements.• Ensure all clinical activities and studies are conducted with the highest ethical standards.

Leverkusen, North Rhine-Westphalia, De

• Provided leadership for the regional PSDM TA staff and coordinated local operations on a day-today basis.• Ensured adequate maintenance and implementation of global clinical Data Management best practice within assigned projects/studies. • Interacted closely with Therapeutic Area head to coordinate local work for assigned studies and projects within global PSDM TA. • Ensured adequate application of global clinical Data Management best practice for all studies in assigned projects.• Acted as the Bayer Data Management liaison on all studies functioning under the Bayer/Covance partnership operating model.• Ensured adequate governance for outsourcing activities in the field of Data Management in co-operation with other Data Management functions (e.g. Clinical Data Center).• Tracked and Reported project progress into management.• Ensured the adequate support of clinicians in medical review and all other affected functions.• Ensured the availability of protocol deviation documents for all studies in assigned projects.• Ensured management of high quality clinical data in studies and projects and application of all relevant SOPs and WPs.• Ensured close collaboration and communication within Study Data Management Teams.• Participated in expert working groups, once assigned by supervisor e.g. Project Washington, CAPA etc.• Promoted teamwork and foster knowledge transfer between projects and sites.

Leverkusen, North Rhine-Westphalia, De

Leverkusen, North Rhine-Westphalia, De

• Support statistical programming activities at a study level. Contribute to the creation, quality and implementation of the Statistical Programming and Submission Support deliverables.• Assist in the completion of programming for all tables, listings, and graphs.• Attend and contribute to Study Team meetings, discussions, and activities covering aspects of all Statistical Programming and Submission Support. • Ensure timely completion of programming for all tables, listings, and graphs. • Ensure SAS validation procedures are followed. • Contribute to and review documents for assigned studies e.g., protocol, CRFs, Statistical Analysis Plans, Project / Integrated Analysis plans for Phase I-IV clinical studies.• Assist in the design, specification, development, evaluation, testing, and selection of systems and software for use in the statistics function.

Leverkusen, North Rhine-Westphalia, De

• Supported all Clintrial 4.3 database design activities within the oncology therapeutic area.• Participated in Case Report Form (CRF) review meetings to ensure accuracy of each final study protocol and informed study team of any inconsistencies or discrepancies between the CRF and protocol. • Annotated final CRF, via Interleaf, in preparation of Global Database Design (GDD) review and compliance check.• Designed the Clintrial database according to approved annotated CRF and assisted Clinical Data Management with testing database entry screens.• Reviewed database validation documents and programmed all study-specific validations and derivations via PL/SQL.• Created database transfer specifications for outside laboratory vendors within the oncology therapeutic area.• Batch loaded, tested and validated lab data transfers prior to final release of data into the production environment. • Worked with study biometricians to ensure database design is consistent with project standards for cross study analysis.• Reviewed various SAS data extracts to ensure data captured within the Clintrial application is accurately represented as SAS datasets prior to moving database from development to the production environment.

New York, New York, Us

• Coordinated all Data Management activities with internal and external laboratories, Clinical and Accenture Data Management unit.• Provided training sessions for all individuals involved with the transfer of laboratory results to Wyeth Clinical.• Imported result data transfers to the Laboratory Information Management System (LIMS) and reconciled all discrepancies which may have occurred over the study lifecycle.• Participated in the LIMS system enhancement initiative, which includes creation of user requirements, unit testing and writing new Standard Operating Procedures. • Performed job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.• Assisted the Information and Technology department with user software installations, creation of new departmental applications, including web-based equipment and document databases, system validation and end user training.

New York, New York, Us

• Assisted Clinical Data Management group in the transition from Clintrial 3.3 to Oracle Clinical 4.0.• Built Oracle Clinical or Clintrial Database(s) according to protocol and annotated Case Report Form.• Created Oracle Clinical Questions, Discrete Value Groups, Question Groups, Data Collection Modules (DCMs), Data Collection Instruments (DCIs) and DCI Books.• Created Clintrial items, panels, forms, page layouts and entry/verification multi-forms.• Assisted in the creation of Oracle Clinical validation and derivation procedures.• Reviewed and resolved data inconsistencies found by the Clinical Data Management group.• Implemented and maintained all Clintrial code lists for the Data Management staff.• Oversaw all Data Management aspects of large phase III trials, including CRO and in-house projects.• Assisted with the creation and validation of new database discrepancy reports used for database lock.• Reviewed and maintained database integrity for clinical trials.

New York, New York, Us

• Monitored, reviewed, and provided modifications to all aspects of the database.• Supervised data entry staff and resolved daily issues.• Identified all data discrepancies via SAS data checks. Completed all Data Clarification Forms (DCFs) and distributed to study sites as needed. Ensured that the Clinical database agreed with returned completed DCFs.• Created and implemented final study specific data conventions document. • Reviewed and prepared all SAE case report forms for data entry.• Provided Data Management support to the Clinical Research staff.