Project Manager

JANET BALLENGER

Johnsburg IL ***** • 224-***-**** • *****.*********@*****.*** linkedin.com/in/janet-ballenger/

SENIOR MANAGER

Clinical experience in the pharmaceutical industry, with extensive experience working in team environments and in managing Trial Master Files for diverse and numerous Phase 1-4 studies. Experience includes site selection, study plan and material development and review, submission for Central ECs as well as documentation preparation for Local EC submissions. Development background includes project management support for operating procedures/work instructions, protocol, conduct management and document management for Phase 1-4, Post-Marketing and Investigator Initiated studies and INDs as well as BLA and NDA submissions. Worked on projects which interacted with MHRA and KIKO (the Japanese regulatory advisory group). TMF Quality and Systems establishing, developing and managing the TMF Group including direct staff management and vendor staff management with oversight of all TMF activities including regulatory inspection readiness and support, internal/external audit, process development, essential document tracking, collection, filing, structure, CRO management, study report appendices compilation and QC. Performing GAP and IMPACT analysis while working with other business process owners allowed for timely submission of requested information to internal and external agencies. Core competencies include:

Project Management Study Compliance Remote/On-Site Monitoring Document Management

CAPA People Management Vendor Management Regulatory Compliance

Internal/External Audits CRO Management Gap and Impact Analysis Quality Control

Process Development Strategic Planning Trial Master File SME Prudent Independent Judgment

Agile Methodology Contract Negoitation Inspection Readiness/Preparedness Global Study Oversight/Proj Mgt

PROFESSIONAL EXPERIENCE

INDEPENDENT CONSULTANT

Project Associate / Business Lead (02/2019)

Business and strategy consultant for Life Sciences / Clinical Operations regulatory documentation consolidation project. Identified and interviewed key stakeholders resulting in current state assessments and future state recommendations. Authored summaries weekly for project lead and project sponsor. Used data visualization to present areas of risk to stakeholders. Developed recommendations for process improvement, system configuration, governance and risk and issue mitigation, utilized Agile approach for meeting milestones and tracking progress.

PFIZER

Sr. Trial Master File Associate (09/2016 – 02/2019)

Provided crucial Trial Master File (TMF) quality support for clinical trial documentation to be consistent with TMF specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements. Ensured a complete and accurate TMF through documentation quality, quality control review and direct support to GCP activities. Ensured routine activities and processes within the TMF team function were in compliance with current regulatory standards by working with internal and external personnel including vendors, CROs and sites as applicable. Worked directly with sites and CROs to meet study compliance expectations which included regular team meetings and metric collection which was presented on monthly basis to senior leadership. Performed quality reviews on 150 out of eTMF compliance, escalated at risk studies appropriately, worked with teams directly using various systems (MS Excel, ACCESS, etc) and recurring meetings to reduce number to five within 10 months. Tracked and reviewed document issues in logs, including follow-up with respective CRO until closure, escalation of critical findings to management and ensured legacy study data points were entered and approved for Registry systems for 100+ studies. Utilized eTMF system for reviewing TMF Compliance as well as setting up study specific eTMF as assigned. Worked cross-functionally with a group of stakeholders to achieve a milestone by utilizing and participating in activities or tasks adhering to specific operational processes. Collaborated with or lead teams in the development of modified operating procedures and work instructions. Project lead for internal pTMF document identification and filing processes including identifying potential vendor enhancements. Maintained independent judgment to balance quality expectations and other stakeholder needs.

HOSPIRA

Sr. Manager, Project Management, Study Start up, Trial Master File Quality Systems (08/2014-09/2016)

Provided vendor identification and demonstrtations for new electronic filing system for clinical studies. Contributed to the configuration plans, development, and use of electronic tools and continuous improvements for documentation management; including in selection and user testing of third-party systems including eTMF, CTMS, IRT/IWR and IRB portals. Delegated and set priorities based upon criticality and importance with the department and as part of the company’s overall directive. Manages TMF and Clinical Operations Document Management programs and processes. Provided quality guidance to personnel related to TMF and start-up as necessary to define and resolve quality issues. Executed quality strategies for maintaining quality documents in controlled manner. Performed contract negotiations & review for investigator initiated studies (both US and RoW) and non-disclsoure agreements and site contracts during study start up activities. Established efficient recordkeeping and filing of quality and essential documents. Averaged 15 study start-ups a year directly, by tracking and providing metrics during site identification, selection and activation. Supported/Drafted/Reviewed study plans and documentation to ensure adequate over site and ICH-GCP requirements were addressed. Reviewed all site-specific essential documents to guarantee an efficient IRB submission and approval process. Oversaw multiple CROs monitoring and document collection. Lead inspection readiness team with 4 indirect reports and 1 direct report to prepare tracking mechanisms across seven studies that spanned over 8 years preparing a gap impact analysis. This work resulted in favorable comments from senior leadership as well as zero major TMF findings noted on inspection report. Performed as Document Management Lead Contact for FDA audit and provided support for BIMO submission. Performed on site reviews of systems used at CROs and by sites to confirm they met expectations. Verified that appropriate systems were identified and utilized to make certain proper and efficient collection of study level and site level documents. Utilized systems in place to review study related documents remotely and on site ensuring adequate data transfer specifications were met to adhere to sponsor SOPs and study plans. Ensured all TMF documents were easily accessible and maintained in an audit ready condition either electronically or in paper format. Performed high-level review prior to TMF lock/archival as well as full TMF content review as needed to confirm inspection readiness. Performed GAP analysis for ongoing and closed clinical studies when regulatory agency requested. Provided monthly updates through the Legacy Hospira Quality Team for a pending submission. Performed Gap analysis when developing and maintaining trend metrics for active Pfizer Trial Master Files compliance/completeness reports to senior leadership on a monthly basis. Identified trends and subsequent gaps allowed for process and policy improvement as well as additional areas of training required for contributors. Worked with colleagues to identify any potential disruptions on cross-functional work streams – primarily in the culture area, recommending contingencies to be put into place before a gap arose. Supervised one Direct report and one indirect (contractor). Inspected readiness and submission timelines ensuring adequate resources were in place, which included approximately 10-15 indirect reports. Performed in an internal CRA role to support Sr Clinical Project Managers during study start up and site selection. Performed on site monitoring of at risk sites for regulatory compliance and EDC review. Worked across multiple business lines and vendors.

ASTELLAS (04/2014-06/2014)

Project Coordinator, Clinical Supplies (Randstad Pharma)

Worked with Clinical Supply group and relevant vendors to prove project support for generating overall study level reconciliation reports: using templates populate shipment history, returns to depots, destruction of IP, utilizing multiple documents stored on shared drives. Supported PAI readiness and submission readiness submissions. Direct interaction with the Investigational Product vendors and depots allowed the project to be compelted ahead of projected time and well under budget.

COVANCE

Global Project Coordinator (AMN Healthcare / Club Staffing) (09/2013-04/2014)

Partnered with multiple Clinical Research Organization Project Managers with daily activities including trial master file reconciliation, documentation collection and review. Work with peers to secure a seamless transition to eTMF studies. Contracted position was completed 3 months earlier than project manager projected. Worked diretly with sites to ensure document submission and retention was within ICH guidelines and within protocol compliance. Facilitated meetings directly with CRO as needed to bring study documentation into compliance. Created, maintained and updated spreadsheets for inventory, document and milestone tracking ensuring contracts were finalized in a timely manner. Direct contact with selected drug supply vendors allowed for full transparency for delivery, receipt and return of investigational products to and from the sites. Worked across multiple projects while following the scope of work as agreed upon and meet all project timelines and final deliverables. Used both old and new systems to allow for a successful eTMF launch. Throughout study start-up, conduct and close out maintained ability to meet Sponsor/Client specifications while adhering to ICH/GCP requirements. Maintained necessary tracking systems to assure transparent access to study documentation status.

OPKO HEALTH, INC. (Formerly CYTOCHROMA)

Senior Study Start Up Manager, Clinical Trial Associate (10/2012-09/2013)

Managed startup activities, vendor communication, contract negotiations for sites and vendors and other project activities as assigned. Performed related duties in line with site management, audit readiness and internal mentoring including remote and on site monitoring. Responsible for two direct reports and ensuring adequate resources were in place. Performed oversight and personnel management. Program and project manager for global studies; including vendor identification, contract negoiations and oversight during conduct of the study. Facilitated and scheduled regular meetings with internal and external stakeholders. Performed site monitoring on a risk based approach as needed ensuring compliance and milestone management. Performed Study Start-up activities included contract/budget negotiations, document development and submission to central and local regulatory bodies, and site management throughout the duration of the study. Studies paramenters varied and included various patient populations including pediatric; thus requiring additional documentation such as informed consent assent documentation.

ABBOTT LABORATORIES

Clinical Study Associate (01/2000-09/2012)

Participated in study start up, conducted and closed out processes for Phase I, II, III and PMOS studies across multiple therapeutic areas such as Oncology, Neuorology, Immunology, and Rare Diseases. The studies included various patient populations from pediactric to geriatric. Activites related to study start up included budget review, informed consent review, non-disclsoure agreements, contract negoiations, regulatory authority submissions, etc. Managed the Trial Master File (TMF), ensuring documents maintained in the file are appropriate and the content of those documents is accurate, complete and consistent with Abbott SOPs and regulatory requirements. Confirmed documents required for regulatory submissions were posted in eDocs to meet submission timelines. Performed an accuracy rating of 98% for all program and study related documents submitted for investigational product release and site activation for four consecutive years. Clinical Study Start Up Lead responsible for all aspects as related to site and CRO document finalization and submission for regulatory authority approvals, contract finalization, and meeting budgetary limits. Developed and implemented streamlined approach to Central IRB interactions ensuring compliance with ICH guidelines and other regulatory bodies.

ADDITIONAL RELEVANT EXPERIENCE

Governmental Service

CIVIL SERVICE, USAF

Personnel Specialist (04/1990-04/1991)

Performed personnel administration duties; assists in development of class specifications; assisted in preparing examinations; participated in recruitment programs; reviewed personnel transactions; wage and salary surveys; established eligible lists and other related duties as required. Worked with personnel during deployment situations ensuring adequate information and resources were made available.

UNITED STATES AIR FORCE – Military Service

Personnel Specialist (05/1985-04/1990)

A personnel specialist in the Air Force is like the human resources manager at a civilian company. Duties assigned were to counsel airmen on their career goals, advising on things like promotions, training programs and job specialties. Responsibilities included a wide array of administrative functions such as duty status changes, leave programs, casualty assistance, and official documents such as operating procedure distribution and change control and letters of reprimand. Additional tasks included managing the Air Force's retention programs, and advising airmen on benefits programs. Accountable for ensuring the Air Force remained in compliance with personnel policies, directives and procedures.

Active Duty Military, Noncommissioned Officer in Charge (NCOIC) Unit Orderly Room, Supply and Logistics and Transportation Units; 5 direct reports.

Achieved rank of Sergeant (Noncommissioned Officer) (E-4/5).

Decorations/Medals/Badges: Good Conduct, Cold War Campaign, Operation Desert Shield/Storm, Small Arms Expert Marksmanship (x4), Rifle Expert Marksmanship (x4), AF Longevity Service, AF Outstanding Unit, AF Overseas Long Tour.

PROFESSIONAL ORGANIZATIONS

Society of Clinical Research Associates (SoCRA)

Pharmacy Technician, Formerly Registered Illinois (inactive)

EDUCATION / CERTIFICATION

Bachelor Degree – Business Administration & Human Resources – Open University (1990)

Certification Clinical Research Professional (CCRP ®) – Society of Clinical Research Associates (SoCRA) (2011-2020)

Career Diploma – Project Management – Alison Online Education (2018)

Career Diploma - Pharmacy Technician – Penn Foster (2010)

Career Diploma – Teacher’s Aid – Penn Foster (2006)

Project Managemenr Foundations: Integration (2019)

DevOps Foundations: DevSecOps (2019)

Leading Projects (2019)

Agile @ Work: Planning w/ Agile User Stories (2019)

Agile Developmen Practices (2019)

Six Sigma - White Belt, Green Belt (2019)

Lean Six Sigma Foundations (2019)

Consulting Foundations (2019)

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