Monica L. Johnson, A.A., B.A.

Scotch Plains, NJ *7076 Email: acuj2r@r.postjobfree.com

Professional Experience

Undisclosed Home Based November 2015 - present

Project Clinical Data Manager Lead-Permanent

Work closely with trial leads, providing day-to-day activities, i.e. listing review, metric reports, creation of trial status reports, etc.

Independently lead multiple, high volume and extremely complex studies within a development program.

Effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations which facilitates a non-problematic trial closure

Review and contribute to the development of trial validation plan related to documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data.

Organize / chair data management meetings

Work very closely with internal/external teams as primary contact for all data management activities.

Lead all reconciliation activities for lab data, SAE and all third party data.

Perform primary project team level customer communication/coordination for CDM activities. Ensure customer satisfaction by making sure the high standards for quality, efficiency and timelines of the deliverables are met.

Immediate supervision of a small group of employees assigned to work on trials.

Janssen / Johnson & Johnson New Jersey July 2008 – July 2015

Principal Clinical Data Manager Lead-Permanent

Devised a “lean” process which allowed the set-up, conduct and data base lock for Phase I trials which allowed projects to be completed in a lesser time frame that larger/longer trials allow for. Process was inducted into a J&J/Janssen working process and is currently being used across early development trials. As a SME for this process, SOPs, WIs and training sessions were carried out. Mentoring was made available as hoc and the process continues to be used currently.

Lead and participated in the creation of small/large molecule PK processes, as two separate processes due to the differentiation of how the data is collected, evaluated and applied to the CSR.

Possessed strong organizational skills and able to effectively collaborate with minimal to no supervision in a team environment or individually across multiple projects and teams successfully prioritizing competing timelines.

Fostered an effective and cohesive team environment among Data Management staff members; treated others fairly and with respect; managed conflicts constructively; provided timely and relevant performance feedback.

Served as the key subject matter expert on topics related to data management activities. Contributions include, but are not limited: mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., SOPs, Work Instruction, Guidance documents, etc.), presenting best practices at internal meeting that have been retrieved from external sources, industry meeting and trainings.

Reviewed synopsis/protocol and attend synopsis Review Committee meetings. Planned and monitored actual study/project metrics; communicating as warranted on project progress, potential risk and appropriate recommendations for identified risks

Managed all study related activities from approved Study Protocol to the final Clinical Study Report to ensure that study execution is punctual based on trial timelines. Tracked and led project-level data management activities: manage IDS teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of GCO teams; identify issues, define and direct resolution measures; reports progress and escalate issues into management.

Primary contact for project teams internally and to outsourced trials to ensure data quality and timely database deliverables. Represents DM in meetings as the core study team member for internal and outsourced studies

Effectively led cross-functional team through the execution of projects assigned across multiple therapeutic areas by providing; resource allocation, adhering to timelines, operating within budget, and assessing out-of-scope work for input to change orders.

Communicate clear direction and established expectations for project timelines and priorities to all the multidisciplinary/cross-functional teams, and the status of task completion on an ongoing basis through data base lock

Evaluated contracted regional CROs and external vendors on an ongoing basis to determine if they fulfill requirements of SOPs, meeting timelines, and are providing a quality product.

Interfaced with the Biostats group on behalf of the Clinical Study team to ensure validated data reporting needs are addressed and met.

Created, approved and archive data management documents including but not limited to; electronic case report form completion guidelines, data entry guidelines, coding guidelines, data review guidelines and data management plan to ensure compliance with data management standards and the study protocol

Ensured project documentation was complete, current, stored appropriately (eTMF) and audit-ready

Supported the development and implementation of Project and Study Data Management strategic initiatives and activities.

Prepared and provided approval of clinical trial database design and validation programming using SDTM standards; and within the realm of DMCC, CDISC, CDASH, Define.xml, annotation and medication/Adverse Events coding.

Ensured timely and accurate completion of all data management activities ; working closely across cross-functional global project teams by developing and maintaining project metrics, timelines, budgets and deliverables

Oversaw and perform (if need be) all data cleaning and study conduct activities including but not limited to electronic data within internal database and all loaded external data streams.

Reconciled serious adverse event (SAE) data in cooperation with the Clinical team and Drug Safety and Surveillance group using RAVE reports, CIOMS and SAETR safety reports.

Effectively managed, led and motivated CRO and other external vendor relationships using strong leadership, organizational, interpersonal and communication skills while prioritizing against competing timelines and managing project work

Reviewed (SOW) statement of work, contracts and out of scope tasks as needed to determine and manage project resource needs and utilization according to project contract/SOW/RFP

Led and supported department initiatives, acting as SME (subject matter expert) for multiple processes. Mentored and trained junior level Global Data Managers individually/or in groups based on specific needs.

Participated in creating SDTM submission ready datasets from raw data by creating/overseeing data transfer specifications, data mapping specifications, PK, ECG, bio-marker (external data as appropriate), lab data transfer and validation specifications.

Provided sound and constructive mid-year and annual performance feedback; assist in setting goals and objectives that were challenging, realistic, and aligned with the organizations/department overall goals and objectives.

Instrumental in obtaining FDA approval of INVOKANA (Canagliflozin) in Europe and in US

Beardsworth Consulting Group, Inc. Flemington, NJ February 2008 – July 2008

Senior Clinical Data Manager-Permanent

Core study team member and primary contact for project teams to ensure data quality and timely database deliverables.

Provided leadership for all data management activities to ensure database accuracy across projects assigned.

Performed as team lead for the execution of projects assigned which includes, but is not limited to; resource allocation, timelines, operating within budget, and assessing out-of-scope work for input to change orders.

Created and approve case report forms, case report form completion guidelines, edit checks, data entry guidelines, coding guidelines, data review guidelines and data management plan to ensure compliance with data management standards and the study protocol.

Communicated project timelines and priorities to all the multidisciplinary teams, and the status of task completion.

Reconciled serious adverse event (SAE) data in cooperation with the Clinical team and Drug Safety and Surveillance group.

Responsible for the accuracy of the database specification documentation vs. the actual database structure.

Prepared and provided approval of clinical trial database design and validation programming.

Responsible for the development, implementation and maintenance of all data management activities within a study from study start up through database freeze/lock.

Performed all data cleaning and study conduct activities through data base lock.

Cmed, Inc. Murray Hill, NJ

Principal Clinical Data Manager/Clinical Project Trial Leader-Perm November 2007 – January 2008

Senior Clinical Data Manager/Clinical Project Trial Leader-Perm June 2006 – November 2007

CPTL Role:

Responsible for overseeing the multidisciplinary project teams to assure accurate and timely completion of all technical and data capture functions required by the study protocol

Guide, direct, supervise, train and mentor project staff to facilitate study success; responsible for conducting clinical studies in accordance with GCP, SOPs, FDA and ICH Guidelines

Managed, tracked, and responsible for ensuring ongoing study activities, study execution and timelines are met

Tracked and compiled patient enrollment, data cleaning progress and overall study progress

Drove quality, and cost for assigned clinical trials ; designed, communicated and implemented project plans

Established scope of work, timelines and processes for project team while prioritizing competing timelines

Ensured integrity of clinical trial data through leading the project teams, training, data review, process improvement and team facilitation

Tracked and understood study progress, out of scope work, budget compliance, and project team responsibilities

Represented the company at Investigator Meetings

Reviewed data management performance against established metrics in a data management performance report, prepared at the conclusion of each study in collaboration with the Director of Data Management and Clinical Operations Head; defined the project team and required resources

Developed, reviewed, revised and evaluated SOPs, study specific procedures, and databases used to manage assigned clinical trials Identified training needs/learning opportunities and participated in the training and educating of company project teams and external customers (physicians, investigators, study coordinators, third party vendors, sponsors, etc.)

As primary point of contact, frequently liaised with sponsor, investigator sites staff and clinical team

Anticipated and identified issues; applied clear and consistent performance standards and handled issues decisively and objectively

Communicated effectively, verbally and in writing, with all internal and external customers (physicians, investigators, study coordinators, third party vendors, sponsors, colleagues, etc.)

Escalated out of scope study needs and issues to the Chief Operating Officer; Resolved technical/study concerns and issues in collaboration with appropriate team member

PCDM Role

Participated in various performance improvement processes DM Role

Line Managed, coached, developed, and provided leadership in addition to staff-appraisals and one-to-one meetings for Clinical Data Associates I, II and Clinical Data Managers Participated in the recruitment of staff; training needs and performance reviews; provided timely and relevant performance feedback.

Foster an effective and cohesive team environment among Data Management staff members; treated others fairly and with respect; managed conflicts constructively

Effectively administered professional coordination and management of clinical trial data on multiple studies, on both an individual trial and project level

Improved effectiveness of the organization by developing new processes, systems and motivate client relations

Ensured relevant, client and Cmed working practices and standard operating procedures are adhered to

Responded effectively, clearly and concisely to requests made by the client for information or presentations, such as workshops and project planning meetings and kick-off meetings as requested

Acted as a liaison on the requirements for specific client to ensure that the data management resolution is of the highest quality in order for databases to be declared clean and locked according to ICH GCP standards

Established overall responsibility for the creation of trial documentation and such as the DMP, CRFs/eCRFs, validations, eCRF completion guidelines, lab and other electronic data transfer specifications

Performed study conduct activities, which include but are not limited to, discrepancy management including generating and resolving queries; external data reconciliation; SAE reconciliation, etc.

Loaded required external electronic data e.g. lab, PK/PD into the trial database at predesignated time points throughout the trial, liaise with the data vendor to resolve any resulting errors, inconsistencies found during reconciliation process, missing data and/or data mapping issues

Responsible for the accuracy of the database specification documentation vs. the actual database structure is SAS data sets and T&Ls prepared and provide approval of clinical trial database design and validation programming

Responsible for the development, implementation and maintenance of all data management activities within a study from study start up through database freeze/lock

Tracked status and progress of data management for allocated trials or centers and be proactive to ensure smooth and successful timely locking of databases.

Responsible for coordinating, chairing and providing minutes for all clinical trial team meetings for multiple assigned studies

Effectively trained site staff and clinical monitors on Cmed's eDC system and provide continued support throughout the life of the trial

Ensured all tasks documented in the client/sponsor contract are completed on time and monitor project budgets, resources and implement cost control measures as appropriate for multiple studies simultaneously

Accountable for communicating any delays in deliverables and out of scope changes to management to ensure the impact is fully understood

Provided a single point of contact for all team members (in-house, client/sponsor and additional external vendors) across multiple studies

Accurately projected the actual effort required for all contracted activities

Effectively lead project team(s) to ensure proper allocation of resources; encourage enthusiasm and commitment to deliver quality results within timelines and budget commitments

Proactively identified potential issues and problems before they emerge and provide resolution and/or escalate if required

Reviewed and updated revenue projections based upon project plan and proposal fees; trigger invoicing processes; initiate change-in-scope amendments Effectively managed client relationships and client expectations

Abbott Laboratories Parsippany, NJ May 2004- June 2006

Senior Clinical Data Manager/Contractor

Responsible for the creation, review and execution of study materials (e.g., eCRF/pCRF, eCRF/pCRF completion guidelines, Data management Plan, monitoring conventions, data base specifications, validations (edit checks), data handling conventions, assumable/self-evident corrections documentation) to ensure conformance with protocol, standardized database structure and standardized programs.

Responsible for the development, implementation, maintenance and closure of all data management activities within a study from study start up through database freeze/lock.

Consistently met or surpassed deadlines according to the highest levels of quality standards.

Assumed overall responsibility for the cleaning of assigned projects to produce high quality and timely database locks for multiple trials/projects simultaneously while prioritizing competing timelines

Performed protocol review specifically related but not limited to the data management section; visit/dosing schema and study design to ensure all data required for analysis is captured in the eCRF/pCRF.

Fostered an effective and cohesive team environment among Data Management staff members as well as cross-functional teams

As single point of contact, liaised between and manage external CRO partners and internal teams for studies where activities are outsourced.

Performed study conduct activities, which include but are not limited to, discrepancy management including resolving data entry errors, generating and resolving queries and applying self-evident corrections, SAE, lab and PK reconciliation

Created and generate bi-weekly and ad-hoc data listings via Oracle Clinical, Microsoft Access, I-Review, J-Review and CTPS that are used across departments to ensure integrity of data and progress of the trial

Mentored and trained junior level Data Managers on study level conduct activities, while assuring uniformity across studies at the project level.

Effectively manage CRO and other third party vendor relationships.

Reviewed (SOW) statement of work, contracts, RFPs and provide input

Led and participated in department initiatives, acting as SME (subject matter expert) for multiple processes.

Instrumental in approval of HUMIRA (Adalimumab) in Europe and in US

Pfizer Inc. Morris Plains, NJ August 2003-April 2004

Lead Clinical Data Manager/Contractor

Performed study conduct tasks including discrepancy management, resolving data entry errors, applying self-evident corrections, generating DCFs, manual review of data listings, ongoing SAE reconciliation, addresses auto-encoding no-hits and locking of individual subject’s data on an ongoing basis.

Responsible for defining, designing, validating data collection tools including testing and approving data entry screens, Oracle Clinical Data Validation Procedures and scanning and indexing system configuration (Eclipse) for functionality and completeness.

Performed database set-up configuration review (db specs) to ensure proper documentation, loading and transfer of CRF and non-CRF data.

Created data entry guidelines and participate in the review of study startup documents including the CRF and the DQMP documents: Data Flow Management Plan, Data Validation Document, Quality Deliverables System, Self-Evident Corrections Document, and Monitoring Guidelines

Provided frequent and timely communication on project-related activities and identified issues to the Database Operations Manager and Headquarters Data Management staff.

Ingenix Pharmaceutical Research (i3) Basking Ridge, NJ August 2002-August 2003

Lead Clinical Data Manager/Contractor

Provided leadership, supervised and trained Data Management junior staff members assigned to work on projects, including -Clinical Data Coordinators, Clinical Data Associates and Data Entry personnel.

Provided invaluable input on budget proposals and client presentations for all data management activities.

Prepared QMR (Quality Management Report) to document error ratio and study metrics.

Assessed and estimated resource needs and projected hours periodically for completion of tasks with Manager of DM and Project Manager as well as provide valuable input for project budget proposals.

Responsible for the creation, review and execution of study materials (e.g., CRF, CRF completion guidelines, Data management Plan, monitoring conventions, data base specifications, edit checks, data handling conventions, assumable corrections documentation) to ensure conformance with protocol, standardized database structure and standardized programs.

Responsible for the development, implementation and maintenance of all data management activities within a study from study start up through database freeze/lock.

Assumed overall responsibility for the cleaning of assigned projects to produce high quality and timely database locks for multiple trials/projects simultaneously.

Performed protocol review specifically related to the data management section; visit schema and study design to ensure all data required for analysis is captured in the CRF.

Served as liaison for all study team members and other functional groups, on all levels, domestic and international.

Provided status and metrics reports on a monthly basis and as requested, pertaining to the integrity and progress of trial.

Performed study conduct activities, which include but are not limited to, discrepancy management including resolving data entry errors, generating and resolving queries and applying self-evident corrections.

Performed data base lock activities which included but not limited to, SAE reconciliation, external data reconciliation, manual review, assure PI signature, etc.

Created and generate ad-hoc listing via Oracle Clinical and Integrated Review that are used across departments to ensure integrity of data.

PRA International Eatontown, NJ

Lead Clinical Data Coordinator II-Permanent February 2002-August 2002

Clinical Data Coordinator I February 2001-February 2002

Provided leadership, supervised and trained Data Management junior staff members assigned to work on projects, including -Clinical Data Coordinators, Clinical Data Associates and Data Entry personnel.

Responsible for the creation, review and execution of study materials (e.g., CRF, CRF completion guidelines, Data management Plan, monitoring conventions, data base specifications, edit checks, data handling conventions, assumable corrections documentation) to ensure conformance with protocol, standardized database structure and standardized programs.

Assumed overall responsibility for the cleaning of assigned projects to produce high quality and timely database locks for multiple trials/projects simultaneously.

Performed protocol review specifically related to the data management section; visit schema and study design to ensure all data required for analysis is captured in the CRF.

Served as liaison for all study team members and other functional groups, on all levels, domestic and international.

Liaised between and manage external sponsor partners for studies where DM activities are outsourced.

Performed study conduct activities, which include but are not limited to, discrepancy management including resolving data entry errors, generating and resolving queries and applying self-evident corrections.

Created and generated ad-hoc status and metric listings via Oracle Clinical and Crystal Reports that are used across departments to ensure integrity of data and progress of trial

Performed data base lock activities which included but not limited to, SAE reconciliation, external data reconciliation, manual review, assure PI signature, etc.

Partners Healthcare Cranford, NJ September 1993-February 2001

Data Management/Medical Records Supervisor-Permanent

Set goals and objectives that were challenging, realistic, and aligned with the organizations/department overall goals and objectives for support staff; Developed and maintained timelines for new projects

Scotchwood/Multicare/Neighborcare Edison, NJ September 1992 – September 1993

Pharmacy Technician/Medical Records Clerk-Permanent

Supervised and created schedule for 13 employees. Enter and fill prescriptions with supervision of a Rph

Belvidere Pharmacy Plainfield, NJ September 1991 – September 1992

Compounding/IV/Pharmacy Technician-Permanent

Compounded detailed medication specific to doctors orders including but not limited to IV admixtures.

Filled prescriptions with the supervision of a registered pharmacist.

Skills

Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, project plan), Oracle Clinical (v4 Medidata Rave (eDC), Inform, Phase Forward, iSpec, ComSpec, Data Diagnostic System (DDS), ThirdPhase (Timaeus) Traditional and eDC database, BCGINet, iReview, J-Review, IVRS, Rescot Pharmacy Systems, Eclipse (eDC), Oracle Discoverer, Seagate Crystal Reports, I-Review, J-Review, DLB Recorder, FMS Explorer, QC Tools, Clinical Reports, AS400, Documentum, E-Submissions, SOARS (SAE reconciliation tool), Lotus Notes, WHO-Drug (familiar), MedDRA (familiar), CDISC, SQL/SAS (familiar), CDASH familiar), Knowledge of FDA regulations, EMA and ICH-GCP guidelines./HIPPA regulations. Extensive experience in multiple EDC systems.

Therapeutic Areas

Gastrointestinal, Allergy; Cardiovascular; Respiratory; Central Nervous System; Neurology; Endocrine, Erectile Dysfunction, Hormone Replacement Therapy, Multiple Sclerosis, Psoriasis, Alzheimer’s; Rheumatoid Arthritis, Crohn’s, Ankylosing Spondylitis, Diabetes, Hypertension, Oncology (solid tumors, blood born, lymphomas, colon cancer); Registry Trials (Alzheimer’s)

Education / Certification

Baker College, Flint, Michigan, Associates Degree, Cum Laude (GPA 3.58), Bachelors Degree – (GPA 3.41)

Lincoln Technical Institute formerly Cittone Institute, Edison, New Jersey – Computer Programming Certificate

Delaware State College, Dover, Delaware

Pharmacy Technician Certification

References Available Upon Request

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