Data Management Associate Director

Audra Rahoi

*** ******* ***., *******, ** *****, 973-***-****, ********@*****.***

Qualifications Summary:

Experienced professional with over 25 years in Pharmaceutical R&D, specializing in Data Management. Highly organized and detail-oriented, skilled in clinical project oversight, resourcing, and cross-functional collaboration to ensure high quality deliverables.

Achievements:

4 ‘Better Because of You’ awards (Regeneron, 2023- 2024)

6 – Bravo Awards – (Daiichi Sankyo, Inc., 2020-present)

18 ‘Better Because of You’ awards – (Bayer, 2015-2020)

Innovation Award – in recognition for assisting in creating the process to eliminate data loads into JReview before receiving the SAS outputs. (2015)

4 ‘LEAD’ Awards – Eisai Medical Research (2009-Present)

26 “Above and Beyond” Awards – Novartis Pharmaceuticals (2001-2008)

“DO AWARD” – in recognition for my work on Tasigna - Novartis Pharmaceuticals (2007)

“Employee of the Year” – Alternatives Inc., 1997

Nomination for NJACP (NJ Association for Community Providers) “Leadership Award -1998 (Honorable Mention: youngest nominee in the history of NJACP Leadership Award)

Job Experience:

Director, Data Management, Internal Medicines (CDU Head)

Regeneron Pharmaceuticals. Inc.

- Internal Medicines, Basking Ridge, NJ (June 2023 – December 2024)

●Managed a team of 13 staff, Associate Directors, Managers & Data Managers for the Internal Medicines group

●Worked with Clinical Study Teams to deliver the project portfolio deliverables

●Provided leadership and/or collaborated with study teams and CRO partners

●Directed the conduct of data management activities for assigned outsourced vendors.

●Ensured high quality data delivery in support of planned analyses, DMC, DSUR, interim analysis, database lock, TLFs, final clinical study report (CSR) and HA submissions

●Planned and developed staffing allocations, including forecasting resources, assessment of candidates, recommended hiring, management of onboarding/training, maintained staff budgets, etc.

●Provided leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs)

●Identified and managed risks at the functional level and/or for assigned project/studies and/or initiatives

●Led the DM Quality triage team, preparing teams for HA submissions and participating/supporting in all inspections and preparation

●Led the initiative for developing an internal Data Management Plan (DMP)

●Led the Data Review and Cleaning initiative. Worked with the relevant FSP/CRO team members to make improvements to the processes and procedures

●Provided leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs). Oversaw 15 Subject Matter Experts (SMEs) with preparing updates to SOPs, WIs and/or training

●Resolved and/or escalated issues encountered at the project/study, and/or functional team level

●Leveraged comprehensive Data Management expertise to promote best practices regionally across the Clinical Trial lifecycle

●Maintained awareness of Data Management emerging trends, technology and best practices and made recommendations for regional improvements

●Developed and maintained peer relationships with leaders in Data Management and related areas

Director, Data Management

Daiichi Sankyo, Inc.

- Oncology, Basking Ridge, NJ (May 4, 2020 – June 2023)

●Manage a team of clinical data managers, mentor staff, assess performance

●Work with Clinical Study Teams to deliver the Project Portfolios by meeting all data management deliverables.

●Provide leadership and guidance to data management teams and collaborate with study teams and CRO partners to meet Portfolio deliverables. Directs the conduct of Data Management activities for assigned outsourced vendors.

●Ensure DM deliverables and timelines are met with high quality in support of planned analyses and submissions

●Leads development of Data Management strategy and solutions at the project and/or study level.

●Plan and develop staffing allocations including assessment of candidates, recommend hiring, forecast resources and maintaining staff budgets

●Leads vendor oversight to ensure that the process, procedures, data deliveries, timelines and study documentation created are of high quality, compliant with the study requirements, SOPs and GCPs.

●Proactively identifies and manages risks at the functional level and/or for assigned project/studies and/or initiatives.

●Ensure timely and quality delivery of the data for DMC, DSUR, interim analysis, database lock, TLFs, final clinical study report (CSR)

●Plans/directs the activities of multidisciplinary teams working on regional initiatives.

●Resolves and/or escalates issues encountered at the project/study, and/or functional team level.

●Acts as coach/mentor within Data Management for Project/Study teams.

●Provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).

●Leverages comprehensive Data Management expertise to promote best practices regionally across the Clinical Trial lifecycle.

●Maintains awareness of Data Management emerging trends, technology and best practices and makes recommendations for regional improvements.

●Develops and maintains peer relationships with leaders in Data Management and related areas.

Associate Director, Data Management

Bayer HealthCare Pharmaceuticals Inc.

- Oncology, Whippany, NJ (Oct. 2018– April 28, 2020)

●All tasks listed below (See PDM tasks listed below)

●Additional tasks in new role:

●Creation of the new internal IB guidance and documents, providing necessary detailed Data Management process and input.

●Manage a team of clinical data managers, mentor staff, assess performance

●Responsible for development and preparation of monthly DM & DS&A training on various relevant Data Management processes, guidance or information.

●Creation all Oncology Standard Tumor/Biomarker Test Scripts for all User Acceptance testing (UAT)

●Supporting the DMW/LSH transition of all new start-up studies in the Oncology area, including, but not limited to: attending various decision meetings, providing guidance and input from a DM perspective, writing new processes and training, etc.

●Attend various Management meetings in support of DM Heads and/or in lieu of DM Heads

Principal Data Manager, Data Management

Bayer HealthCare Pharmaceuticals Inc.

- Oncology, Opthamology & Neurology, Whippany, NJ (Nov. 2015 – Oct. 2018)

●Responsible for the overall DM oversight for all studies within assigned compound(s).

●Responsible for the coordination of all data management related activities for Phase I-III trials in the Oncology group, including but not limited to: all start-up processes, maintenance and cleaning of all ongoing trial data, and database lock activities.

●Manage individual study timelines.

●Managing project budgets.

●Oversight of approximately 8 SDMs and 5 CDMs. This includes mentoring and training of all study and/or compound DM related tasks, processes or metrics.

●Develop, review and provide feedback on various SOPs, Guidelines, Processes, etc.

●Participating on various committees and initiatives, including but not limited to: Standards, UAT Process, Exception Listings, Data Management Plan, GDM Study Plan & timeline, etc.

●Create study protocol deviation specifications, and test/validate the programming.

●Management of the Data Management CROs.

●Selection and creation of all trial CRF’s/ CCG’s, and ensuring CDISC compliance.

●Review and creation of all compound validation checks.

●Responsible for the review and approval of trial protocols and/or amendments.

●Responsible for testing trial databases (User Acceptance Testing) and/or creation of related test scripts.

●Vendor data integration, development and testing.

●Creation of all external vendor data transfer specifications.

●Training of all site coordinators/CRAs on the trial specific data collection (InForm) for trials via Investigator Meetings.

●Working on various ‘Due Diligence’ projects for various potential external compounds, currently 3 to date.

Sr. Manager, Data Management

Eisai Medical Research

- Oncology, Woodcliff Lake., NJ (December 2011 – Oct. 2015)

●Responsible for the coordination of all data management related activities for Phase I-III trials in the NGM Product Creation Unit, including but not limited to: all start-up processes, maintenance and cleaning of all ongoing trial data, and database lock activities.

●Compound Lead for one of the NGM compounds.

●Mentoring/Management of all Data Managers assigned to the compound (including, but not limited to: study design, EDC, internal processes, internal systems, JReview, InForm, etc.)

●Manage study timelines.

●Managing project budgets.

●Manage the ‘DM Forum’ for all of NGM and Medical Affairs

●eDC SME for NGM.

●Liaison for all EDC/IRT related activities with Oracle (including but not limited to: IRT integration, InForm upgrades, InForm ticket process improvements, creation of new processes/eCRF development of integration of IVRS data (IRT) into InForm, etc.).

●Responsible for the development and/or upgrade of various SWPs, Guidelines, Processes, etc.

●Participating on various committees and initiaves, including but not limited to: Standards Committee, Query Management Committee, SAE/AESI Committee, Standards Listing Committee, ISDB, Accenture Calibration, Data Quality Plan Initiative, Standard External Data Transfer Specifications, Submissions process improvement Committee, etc.

●Management of the Data Management CRO.

●Selection and creation of all trial CRF’s/ CCG’s, and ensuring CDISC compliance.

●Review and creation of all study validation checks.

●Responsible for the review and approval of trial protocols and/or amendments.

●Responsible for testing trial databases (User Acceptance Testing) and/or creation of related test scripts.

●IVRS Integration development and testing.

●Creating standard specifications for listings (both exception & manual) to clean clinical data.

●Creating study specific reports in both InForm and/or in IReview. Also creating spec documents for all SAS exception listings.

●Creation of all external vendor data transfer specifications.

●Responsible for conducting/running UAT kick-off meetings.

●Training of all site coordinators/CRAs on the trial specific data collection (InForm) for trials via Investigator Meetings.

Sr. Clinical Data Manager

Eisai Medical Research

– Oncology, Woodcliff Lake., NJ (November 2008 – December 2011)

●Responsible for the coordination of all data management related activities for Phase I-III trials in Oncology, including but not limited to: all start-up processes, maintenance and cleaning of all ongoing trial data and database lock activities.

●Selection and creation of all trial CRF’s/ CCG’s, and ensuring CDISC compliance.

●Review and creation of all study validation checks.

●Management of the Data Management CRO

●Managing study timelines.

●Management of all internal Data Managers assigned to my studies.

●Responsible for the review and approval of trial protocols and/or amendments.

●Responsible for testing trial databases (User Acceptance Testing) and/or creation of related test scripts.

●Mentoring on eDC study processes for other colleagues in data management.

●Creating standard and study specific exception/manual listings to clean clinical data.

●Creating study specific reports in both InForm and/or in IReview. Also creating spec documents for all SAS exception listings.

●Creation of all external vendor data transfer specifications.

●Responsible for conducting/running UAT kick-off meetings.

●Participating on various tasks forces, including but not limited to: creating the Data Management Work Plan, review and feedback of all recently created standard edit checks, review and feedback of the new SWP’s for Data Management, and review and feedback of the new standard eCRF’s, etc.

●Managing study budgets.

●Training of all study personnel on the trial specific data collection (InForm) for trials via Investigator Meeting.

Sr. Clinical Manager/ Clinical Research Scientist:

Novartis Pharmaceuticals

– Oncology Division, Florham Park, NJ, (September 2006 – May 2008)

●Responsible for coordination of all trial related activities for Phase I-III trials in Oncology.

●Responsible for writing of study synopsis/protocol.

●Responsible for writing protocol amendments.

●Assisted in the development/ review of clinical study reports, including annual IND reports, CSR’s, etc.

●Scientific review of clinical study data on an ongoing basis.

●Management of CRO’s, the internal support team, and other 3rd parties prior to and during the clinical trial.

●Responsible for maintaining study budgets (completing Study Specification Worksheets, tracking of study budgets, allocating monies, etc).

●Review and report safety findings via Powerpoint/ Excel presentations.

●Responsible for planning and executing investigator meetings, including but not limited to: Creation of all study presentations

●Mentoring of newly hired team members.

Clinical/Project Data Manager:

Novartis Pharmaceuticals

– Oncology Division, East Hanover, NJ (May 2001-July 2002, Contractor) /(Aug. 2003-September 2008, permanent employment)

●Data Management for 11 Oncology trials, including both in-house EDC trials and out-sourced CRO trials.

●Development and start-up processes for clinical trials (oncology and clinical pharmacology). Assisting clinical teams to review study protocols, and providing feedback. Creation/selection of all trial CRF’s/ CCG’s. Completing Validation and planning reports for the clinical trials via CREDI. Responsible for testing newly created databases for problematic areas and/or mistakes (which involves working with database designers to resolve all issues.

●Responsible for ongoing review and cleaning of all trial data throughout the trial. Reviewing all case report forms for accuracy and completeness. Freezing and locking electronically sent data in appropriate timeframes set by the company NIPS. Identifying, resolving, or querying of all inconsistent or questionable data. Reconciliation of all CRF data, including SAE’s, and 3rd party data. Maintaining all clinical data needed for trial, including lab ranges, protocol violation information, randomization data, treatment group data, and CRF data. Communicating with relevant sites and company personnel to ensure all aspects of the clinical trial is on target. Generating reports on the in-house clinical trial data, via DM Query Tool, PhOSCO report tool, GRT tool, or I-Review.

●Member of CRF Standards Committee. Responsible for the creation of standard CRF pages, as well as performing UAT on newly revised or developed CRF pages. Also assisting in the creation of standard CCG’s for CRF pages.

●Managing archiving efforts for 100+ studies while working in Clinical Pharmacology.

●Training all clinical trial study staff (including doctors, nurses, site personnel, etc.) on the department database used to maintain all study data, and on company processes and procedures.

●Triainer/Superuser for I-Review, (done locally with Novartis employees, including other Data Managers, Clinical Trial Leaders, Field Monitors,Trial Statisticians, etc.). This also included working with the training team to develop a new training for the rollout of version 8.

Human Resources:

HR Generalist

Rudolph Technologies

(Aug. 2002- Mar. 2003)

●Handled all recruiting, selection of potential candidates, and interviewing for both exempt and non exempt positions. Maintained relationship with all outside resources used in the recruitment process.

●Trained all newly hired staff, including developing a new and improved PowerPoint presentation during the Orientation training.

●Arranged all pre-employment physicals, background checks, and/or other necessary screening for potential or newly hired individuals.

●Generated monthly/annual reports including, but not limited to, open job status, time per hire, and cost per hire.

●Developed and revised various HR tools including: company/department policy and procedures, interviewing handbook for all supervisory/managerial staff, & supervisory skills training.

●Created and/or revised Corporate Job Descriptions for roughly 50-80 positions. Assisted with yearly performance appraisals/reviews and annual salary/wage increases.

●Conducted exit interviews and preparation of all COBRA/ benefit letters.

Social Services:

Social Worker/ Regional Director

Alternatives, Inc. (1994 – 2000)

●Directing/Managing residential programs for non-profit, social service agencies. Supervision of all program managers and staff, compliance all of state rules and regulations, individual meetings with residents, record keeping, employee training, and development and implementation of all agency procedures.

●Assisted the HR director with all functions of staffing, training, performance reviews/appraisals, employee relations, job description writing, etc.

●Proposal writing for grants for the development and/or expansion of agency programs.

●Conduction of intakes on all potential clients for agency programs.

●Assisted/ supervised several agency fund-raisers or events.

Skills:

Inform, I/JReview, IRT, RAVE, LSH, DiSQuS, RAVEN, DMW, Clintrial /Clintrial Retrieve/Manage, TOSCA/MACUMBA, PhoSCO, ClinAdmin/WinFx, MediData, Oracle Clinical, IND tool, Lotus Notes, Windows XP, Powerpoint, Microsoft Outlook, Microsoft Office, Microsoft Project, Lotus Notes, SPARQ HRIS, etc.

Education:

Bachelors of Science in Psychology (1994), Minors in Biology and Sociology

Le Moyne College, Syracuse, New York

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