Manage up to nine direct reports, including Study Data Managers, SAS programmers for SDTM mapping, Rave builders and Data Acquisition Specialists

Spearhead the data table used to respond to the FDA for a site inspection finding, engineering the solution and validating the output while reducing timelines by one week

Manage CDM tools and processes for non-CDISC filings to be used for over eight filings in 2017

Perform resource manager duties for 40+ studies, editing demand and projections on PlanSource (Human Resources system) to balance vendor and full-time headcount

Managed a combination of Study Data Managers, Data Acquisition Specialists and Clinical Programmers

Supervised two rotations within the department, one for project management within Clinical Programming Reporting and another for ClinicalProgramming Transformation

Lead team of programmers for support of CDISC and non-CDISC deliverables

Introduced projects for automation of SDTM bookmarking and mechanization of vendor-data type searches

Managed global resourcing for Transformation for both Roche sites and FSPs

Collaborated with gRED Operations for data reporting of clinical data

Managed two DDE concurrent filings by establishing contracts with a vendor, coordinating the creation of SDTM datasets, collating information for the eSub group, and producing annotated CRFs

Took ownership of patient profile and narrative tracking sheet creation for Safety Science, Clinical Science and narrative writers to ensure global alignment of work practices

Directed the training of SSF reporters in the Hyperion tool for data cleaning reports and narrative writing, and created data listings for the GOG filings that led to additional indication approval

Trained 20 staff members across SSF and Inventive in RECIST (Response Evaluation Criteria in Solid Tumors) to better support Operations and Clinical Science

Programmed listings for two of the initial bridging studies, which became the template for integrated Roche and Genentech Data Management processes

Led the CLEAR project for both OCL and EDC (versions 2.0, 2.5 and 3), facilitated the development and QC of reports and aided in trouble shooting of SAS IntRnet code

Supported the Kadcyla filing as sole Clinical Programmer on pivotal trial (TDM4370)

Piloted edit checks for the co-op study GOG0218 to assess and later ensure quality of third-party data

Represented SSF Data Management in the Genentech Medical Data Review Initiative, harmonized reports for Clinical Science

Provided input to the Migration Working Group, led the creation of the SAS comparison report

Created learning materials and carried out train-the-trainer sessions for the use of the SAS comparison report which was ultimately utilized by the whole CP-Build group