Brian Bottema

Clinical Data Manager

Mooresville, IN 46158

ad0ll6@r.postjobfree.com

317-***-****

To obtain a challenging position in clinical research where advancement is based on initiative, merit, and performance. I am seeking a position that utilizes my accumulative skills for the company's benefit and will further my own career goals.

Authorized to work in the US for any employer.

Work Experience

Senior Coordinator - Data Monitoring Committees (DMC)/End Point Adjudication Committees (EAC)

Advarra Inc. - Indianapolis, IN

June 2019 to February 2023

• Collaborated with the study teams to design, development and test the outcome registries and clinical trials.

• Collaborated with the clinical sites to get local or central IRB approval and clinical site contracts executed.

• Managed all invoices from the sites and sponsors for the outcome registries and clinical trials.

• Conducted Site Initiation Visits once the sites got IRB approval and contracts fully executed.

• Conducted any site trainings needed after site initiation for outcome registries and clinical trials.

• Coordinate and manage all required regulatory documents throughout the conduct of the outcome registries and clinical trials.

• Create and maintained the Date Entry Guidelines and Database Structure Documents for outcome registries and clinical trials.

• Coordinated the annual due diligence for all the outcome registries and clinical trials as well as all the data monitoring committees.

• Conduct all monthly reporting as required for the outcome registries and clinical trials.

• Coordinated any data reviews required by the Data Monitoring Plan or Data Validation Plans as required by the outcome registries and clinical trials.

• Coordinated any data locks and reviews as required by the sponsor or Protocol.

• Point of contact for all site personnel regarding the outcome registries and clinical trials.

• Assist in supporting the DMC/EAC group.

Clinical Data Review Expert

Your Encore - Indianapolis, IN

November 2017 to December 2018

• Conducted clinical data review of specific data points utilizing data tables prepared by SAS programmers.

• Assigned to review of RECIST, irRECIST, Primary Diagnosis and AJCC staging data

• Created queries and reviewed queries created by other reviewers prior to sending to Data Management to ensure clarity, consistency, and quality of query wording.

• Worked with Data Management to ensure the queries were properly addressed to meet the expectations of the study sponsor.

• Reviewed clinical data and query responses for possible protocol deviations to report to the study sponsor and site monitors.

• Utilized Oracle Clinical to post and address queries generated.

• Met all clinical review and query resolution deadlines for study sponsor's interim analysis of safety and efficacy data.

Technology Asset Processing Associate II

Ingram Micro ITAD Services - Indianapolis, IN

October 2014 to July 2017

• Processed inbound electronic and information technology assets.

• Utilized proprietary software to sort and test assets for recycle or refurbishment and resale.

• Sought and accepted additional responsibilities including training new associates.

• Filled work orders and packaged merchandise accurately and appropriately.

• Ensure inbound and outbound shipments are accurate and free of damage.

• Adhered to all company policies and procedures regarding data security to protect customers intellectual property and personal information.

Co-Owner

B2 Computer and Audio - Indianapolis, IN

November 2012 to October 2014

• Hardware repair replacement or upgrades for all laptops, PC, and most phones.

• Acquisition and delivery of computer, laptop, and phone hardware

• Complete installation of car and home audio entertainment systems.

• Complete installation of private home security systems.

• Recycle and disposal of old electronic equipment and hardware.

• Managed all work completed by the Software Specialists.

• Managed the completion of all hardware work orders.

• Managed the issuing and collection of temporary replacements (loaners) to customers.

• Managed all inventory and assets of the company.

• Maintained all accounting and tax records.

Data Management Consultant

Hoosier Oncology Group - Indianapolis, IN

January 2006 to July 2012

• Coordinate the development and validation, implementation, assessment, and training for electronic data collection and management systems.

• Provide input during the protocol development process to ensure protocol is in alignment with our database standards.

• Prepare monthly reports detailing accrual, toxicity, response etc. for review by sponsor investigators and Clinical Trials Monitoring Committee.

• Prepare reports for interim analysis of clinical trials which require formal data and safety monitoring boards.

• Act as data management liaison for Clinical Trials Monitoring Committee (CTMC), attending meetings and providing information as required.

• Serve as liaison with biostatistics core and database development team with regards to data collection, review and analysis.

• Create study-specific and global tools/aides for HOG site personnel to assist in the timely and accurate collection of data.

• Compare and reconcile SAE data from safety reporting database with Adverse Event data in the clinical database.

• Provide support and advice to other data team members as needed.

• Coordinate the development and validation, implementation, assessment, and training for electronic data collection and management systems.

• Coordinate the review and analysis of clinical data for abstract and manuscript submissions with authors, study sponsors and biostatistics.

• Prepare monthly reports detailing accrual, toxicity, response etc. for review by sponsor investigators and Clinical Trials Monitoring Committee.

• Prepare reports for interim analysis of clinical trials which require formal data and safety monitoring boards.

• Design electronic data capture requirements, electronic and manual data consistency checks and data entry guidelines.

• Plan and present workshops on data collection to nurses and data managers as needed.

• Document and reconcile serious adverse events, protocol deviations and eligibility exceptions.

• Code adverse events, concomitant medications and other data as needed.

• Responsible for monitoring trial stopping rules and providing status reports.

Clinical Data Manager

February 2004 to January 2006

Eli Lilly and Company - Indianapolis, IN

• Performed the review of clinical data using SAS programming.

• Responsible for ensuring data management documents are inspection ready.

• Track and address issues associated with data management metrics such as clinical report form and query backlogs.

• Developed clinical trial documents such as clinical report forms, clinical report form instructions, field edit descriptions, paper flow, and data validation plan.

• Provide a clean, locked, quality database on time and within budget.

• Coordinated database audits, peer reviews, and database quality reviews.

• Create, run, and review data reports to ensure database consistency and quality.

• Coordinate and participate in data lock process.

Document Quality Coordinator

Technisource at Invensys Inc - Indianapolis, IN

August 2003 to January 2004

• Ensured software validation documents met quality standards set by Eli Lilly and Company

• Formatted test cases written by software engineers into templates provide by Eli Lilly and Company.

• Archived final software validation test case documents into Documentum.

Clinical Data Management Consultant

Atlantic Search Group at NeoPharm Inc - Lake Forest, IL

March 2003 to July 2003

• Provided data management input for study protocol development.

• Developed and reviewed Case Report Forms and Case Report Form completion guidelines.

• Tracked data management metrics for all protocols and coordinated with CROs to meet project deadlines.

• Ensured adverse event and concomitant medication mapping is consistent across all studies.

• Reviewed data validation plans and field edits to ensure protocol objectives are meet.

• Ensure the study database structure is correct and captures all information on the case report forms.

• Created case report form standards for ease of study development and consistency across protocols.

Clinical Data Manager

Eli Lilly and Company - Indianapolis, IN

September 2001 to March 2003

• Conducted electronic data capture training and participated in clinical trial start-up meeting.

• Responsible for ensuring data management documents are inspection ready.

• Track and address issues associated with data management metrics such as clinical report form and query backlogs.

• Developed clinical trial documents such as clinical report forms, clinical report form instructions, field edit descriptions, paper flow, and data validation plan.

• Provide a clean, locked, quality database on time and within budget.

• Coordinated database audits, peer reviews, and database quality reviews.

• Create, run, and review data reports to ensure database consistency and quality.

• Coordinate and participate in data lock process.

Pharmaceutical Buyer / Product Manager

Bindley Western Drug Co - Indianapolis, IN

May 1999 to September 2001

• Responsible for managing over 720 million dollars of annual inventory in 16 distribution centers across the country.

• Negotiate deals and contracts with suppliers.

• Expedite late purchase orders and coordinated transfer inventory between distribution centers to maintain customer service levels.

• Identify overstocked product for return to suppliers.

• Maintain reorder calculation parameters of K3 Replenish (inventory management software) to increase inventory turns and maintain good customer service levels.

• Utilize K3 Replenish for various inventory and sales reports as required by our suppliers.

• Utilize K3 Replenish to determine the changes in demand caused by the contract and formulary changes made by our customers.

Director of Purchasing

Omnicare- PRN Pharmaceutical Services - Indianapolis, IN

April 1997 to May 1999

• Responsible for procurement of all drugs and medical products for a pharmacy that serviced6,000 long-term healthcare patients.

• Prepared pharmacy for all quarterly inventory audits.

• Negotiated contracts with suppliers and service companies.

• Supervised the workflow of 20 employees while serving as Technician Supervisor.

• Created MSDS and emergency policy and procedures to meet JCAHO (Joint Commission for the Accreditation of Healthcare Organizations) requirements.

• Created and implemented educational in-services to meet JCAHO requirements.

• On-call IV technician for weekend coverage.

Pharmacy Technician / Program Manager

Pharmacy Corp of America - Indianapolis, IN

February 1996 to April 1997

• Team leader on self-directed work team.

• Responsible for purchasing and inventory of all IV solutions and disposables.

• Compounding of hyperals, chemotherapy, large volume IV's, IV piggybacks, pain management etc.

• Responsible for insuring all areas meet JCAHO requirements.

• Integrate the use of Federal Express shipping capabilities to maintain various large accounts.

• Developed technical systems for Matria (national home infusion account to cease pre-termlabor).

• Served as IV Technician for weekend coverage.

Central Pharmacy IV Technician

Indiana University Hospital - Indianapolis, IN

June 1991 to February 1996

• Preparation of hyperals, chemotherapy, large volume IV's, IV piggybacks, pain management etc. using aseptic technique.

• Responsible for daily ordering of medical supplies.

• Preparing and stocking medications on mobile cart for hourly deliveries to the nursing units.

• Responsible for narcotic deliveries to nursing units.

• Disposing of all chemotherapy and IV waste.

• Training of new technicians on sterile technique, calculations, and hospital procedures.

Education

BS in Business Administration

Indiana Wesleyan University and IUPUI - Indianapolis, IN

April 2005

Skills

• ORACLE Clinical (2 years)

• BRIO - Data Reporting Software (7 years)

• Leadership (4 years)

• Clinical trials (10+ years)

• Computer literacy (10+ years)

• Data management (10+ years)

• Time management (10+ years)

• Information Security (5 years)

Awards

Poster Presentation at American Society of Clinical Oncologists (ASCO) annualConference 06/2011 Chicago, IL. June 2010

“Phase III double blind placebo-controlled crossover study evaluating a 5HT3 antagonist +dexamethasone +/- aprepitant in germ cell tumor patients receiving 5-day cisplatin combinationchemotherapy”. Awarded Poster Presentation at ASCO annual Conference 06/2011 Chicago, IL.

Certifications and Licenses

Certified Clinical Data Manager (CCDM)

July 2008 to July 2016

CITI Program for the Protection of Human Research Subjects (GCP Certification)

May 2022 to May 2024

Publications

Pemetrexed Plus Cetuximab in Patient with Recurrent Non-small Cell LungCancer (NSCLC)

https://pubmed.ncbi.nlm.nih.gov/19701110/

October 2009

Journal of Thoracic Oncology Volume 4, Number 10, 10/2009

Additional Information

Computer Skills:

Electronic Data Capture Software: Phase Forward/InForm, Omnicomm/e-Data Capture, Metadata/Rave,Forte/Oncore, Oracle Clinical.

Reporting Software:

Brio reporting by Hyperion, J-report by Jasper, Oracle Discoverer, Crystal Reports

Other Software:

Sharepoint, Tableau

Contact this candidate