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Cmi - Lead Crs Clinical Data Reviewer Resume Example

Mason Williams
XXX XXXXXXXXX XXXXX, Sellersville, PA 18960
H: XXXXXXXXXXXX
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Summary
Pharmaceutical research professional with 32 years of nursing.  I am currently seeking positions as a paralegal or legal nurse consultant. I have supervisory/management and pharmaceutical clinical trial experience. Comprehensive knowledge of the research and development process, derived from multi-functional job roles within the healthcare and the pharmaceutical industry. Research has focused primarily on early development clinical oncology, but includes all phases of the drug development process. Key research expertise areas include: data management, trial management, protocol development, project management and has earned reputation as a self-directed professional with problem solving, communication, and management skills.
Skills
Experience
Lead CRS - Clinical Data Reviewer 04/2013 to 09/2014 CMI/Celgene Corporation 15 Summit, NJ
  • CPM for filing trial Data review Cross departmental functionality Vendor management Dotted line CRS reports Site clinical data management Clinical lead for Protocol 002 in all meetings Assumed Lead Role in Sept and oversaw a datapoint clean up and QC review for DBL 10 April 2014review Randstad Pharma/Astellas 05 Oct.
Consultant - Principle Data Manager 10/2012 to 04/2013 Astellas Pharma Chicago, IL
  • ImClone Systems - A Wholly Owned Subsidiary of Eli Lilly and Co.
  • 19.
Pharmaceutical Consultant/Study Trial Manager 03/2012 to 07/2012 Imclone/Eli Lilly Bridgewater, NJ
  • Manager all aspects of clinical studies including: Vendor Management and Site Management Clinical Data Review, review of tables, figures and listings, CRF completion quidelines Budgets Reviewing various clinical documents e.g.
  • protocols, Clinical Study Reports, Investigator Brochures, Monitoring Guidelines.
Clinical Project Data Manager 07/2010 to 03/2012 General Electric Healthcare
  • Currently managing the clinical data review and analysis of a novel radiopharmaceutical in the oncology therapeutic area Responsibilities include: Working with the Clinical Monitor to author protocols, presentations, pathology manuals Interfacing with project management and finance to develop and manage timelines for study enrollment, site selection and start-up activities, monthly study budget forecasting, CRO and contractor resource and budget estimates Insuring proper data collection for multiple studies in both domestic and international markets Acting as primary contact on clinical data issues within the clinical project management department and the Data Management department Interfacing with the biometrics department, regulatory affairs, CMC, finance, project management, CROs - both clinical and laboratory vendors Providing review of clinical data via data listings and tables, review of Statistical Analysis Plan (SAP), coordinate clinical monitor feedback on interim analysis plans, SAPs and tables, figures and listings.
  • Providing clinical data input for eCRF development, including UAT, review and approval of data validation specifications, data management plans and CRF completion guidelines Organizing the bio-specimen collection for the project Co-facilitating a team to standardize bio-specimen collection and related data collection across multiple therapeutic areas Acting as primary contact for new central pathology laboratory to establish consistency for oncology trials Collaborating with Data Management to standardize collection of Oncology Data Appointed to a division level GE committee which oversees a process improvement initiative across GE Healthcare Data Systems and Software: Inform, various clinical dictionaries, SAS view®, EXCEL.
12/2006 to 07/2010
  • Manager in Clinical Research Oncology with eight direct reports and management oversight for eight compounds including three heavy weight compounds Responsible for direct supervision of Merck employees and contractors Management responsibilities included orientation, career development, performance management, mid and end of year performance evaluations, employee hiring and termination.
  • Participated in hiring interviews and contractor salary negotiation Participated in quarterly functional area management meetings and training Participated in daily/weekly resource discussions for a large oncology portfolio and resource and budget forecasting Managed team training budget Co-clinical Subject Matter Expert for development of a specimen data collection system and Biomarker development Clinical Subject Matter Expert for Merck Translational Pipeline in collaboration with a regional cancer centre consortium.
  • Interacted with various departments including Executive Management in Clinical Oncology, safety/toxicology, Molecular Profiling, Bio-informatics, IT, Clinical Data Management, Merck Data Standards Committee, Clinical Oncology, Epidemiology, Biostatistics, the Privacy Office and Office of Corporate Counsel.
  • Worked with Bio-Informatics team to develop a database system that would allow large database transfers between an academic oncology center and Merck.
  • Through this project, I was involved with the various intercompany CDISC teams to develop the biospecimen, pathology and radiology SDTM domains.
  • Worked with Director at Moffitt Cancer Center M2Gen to augment the in-house EMR database in each clinic to collect the necessary clinical data for upload into the Moffitt data warehouse for transmission to Merck.
  • The purpose was to have enough clinical data along with molecular profiling data, gene signature data and radiology data to begin to develop the ability to recognize responders versus non-responders in clinical trials or the clinic.
  • We collaborated on tissue tracking systems and brought SNOMED database into Merck to assist with granular coding of histopathology information.
  • The goal of our program was a personalized approach to cancer care.
  • As a result of our efforts, the team was awarded the Team Award - Bio IT World Best Practices 2008 - Merck-Moffitt Information Pipeline As Program Lead, the responsibilities included database design for Inform Clinical Database, edit check programming, eCRF design, author of Medical Monitoring Plan which outlined the data handling specifications for the protocol including designing the tables and listings for medical review, and facilitated cross-functional clinical data monitoring meetings for ongoing data review.
  • Other responsibilities included attending database lock meetings to review progress of data cleaning activities prior to lock.
  • This included review of all data and coding conventions.
  • Functioned as Program and Co-program lead on four early phase development compounds Led clinical filing activities for an oncology International Marketing Application.
  • Successfully led frozen file activities for 17 U.S.
  • and international studies.
  • Developed detailed study design specifications, medical monitoring plan of study data, and summarized results for assigned MRL clinical trials.
  • Authored and developed clinical sections of protocols, CSR, WMA/CTD subsections, and regulatory agency update reports.
  • Conducted literature reviews; drafted background sections of documents and directed the authoring activities of junior staff.
  • Supported post-filing activities by authoring responses to regulatory agency requests.
  • Supervised the data tabulation efforts of junior staff.
  • Supported clinical research advisory committee presentations by assembling background materials, primary presentations, and back-up slides.
  • Developed detailed plan for program wide medical monitoring of patient safety and efficacy results.
  • Supported clinical research physician in scientific leadership/investigator initiatives including preparation of publications, and meeting presentations, including those requiring in-depth understanding of individual studies and the integration of clinical study data.
  • Collaborated in the preparation and/or delivery of therapeutic area training to junior staff members and functional areas supporting clinical development.
  • Managed performance and professional development of direct reports.
  • Developed data standards for oncology for various phases of clinical trials.
Senior Clinical Scientist - Manager 01/2004 to 07/2010 Merck and Company North Wales, PA
Project Data Manager - Oncology Therapeutic Area Head, Vaccines 01/2004 to 12/2006 Merck and Company
  • Initiated and developed the Oncology franchise within Worldwide Clinical Data Management Operations.
  • Strategic project management position working with multiple departments within Merck to establish overall Merck Oncology Franchise Training session on basic concepts of oncology for data, statistics, IT, clinical Included defining oncology data CRF, database, reporting standards Standing member of Oncology Document Review Committee Provided data and authoring/QC support as needed for NDA Successfully led the data management activities for the ZOLINZA (vorinostat) U.S.
  • filing for CTCL and facilitated data activities for post marketing commitments.
  • Built the infrastructure and oversaw the oncology franchise for Merck within the Clinical Data Management Division for 6 oncology compounds with multiple study protocols programs.
  • Managed six vaccine programs including pneumovax and hepatitis, Pedvax® and Comvax®.
  • Responsibilities included developing and overseeing standards used in Oncology research for collection of data in novel compounds.
  • Included integration of clinical, radiology and bio-specimen data.
  • Secondary responsibilities include interacting with the project management for NCI trials and key opinion leader sites Collaborated with the clinical dictionary department to update the drug dictionary with oncology drug regimens.
Associate Director 10/2001 to 01/2004 Yamanouchi USA Paramus, NJ
  • Therapeutic areas: Urology, Cardiovascular, CNS, and Oncology Lead Data Manager for the Company's first US/worldwide submission of a drug product as an e-CTD Managed and audited multiple CRO partnerships Collaborated on protocol, CSRs and safety narratives for the filing Collaborated on formally establishing the Data Management Department in the US Developed, with the Director of Data Management, department Standard Operating Procedures Collaborated on development of the Standard Operating Procedures for the Statistics department Collaborated with the implementation of Oracle Clinical Lead Manager for MedDRA coding initiative and coding manager.
Manager Sr. Data Management Associate Manager of Data Quality Compliance 12/1998 to 10/2001 Aventis Pharma Rhone-Poulenc Rorer Bridgewater, NJ
  • Developed, implemented & maintained DM SOPs, training records, training material & programs related to SOPs and processes.
  • Validated new systems and subsystems.
  • Worked with consultants to develop risk management and gap analysis documentation and User Requirement Specifications.
  • Monitored data quality through review of End Study Quality Audit & Ongoing Data Review reports including Aventis affiliates & CROs.
Senior Clinical Research Associate and Manager 01/1998 to 12/1999 Premier Research Worldwide Philadelphia, PA
  • Therapeutic Areas: Oncology-Breast, Prostate, Lung, Barretts, GI, B-cell Non-Hodgkin's Lymphoma, Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme, and FAP (pre-cancerous), Cardiovascular-both pharmacologic agent and device, Dermatological Disorders, Metabolic Disorders, and CNS.
  • Lead CRA responsible all aspects of the trial maintenance for in-house monitoring.
  • Developed a department within Clinical Research to facilitate clinical data review.
Clinical Research Assistant 12/1996 to 10/1997 SCIREX Corporation Blue Bell, PA
  • Therapeutic Areas: Vascular, Critical Care Respiratory.
Clinical Research Associate 01/1996 to 01/1996 Sanofi Winthrop Malvern, PA
Contractor-Clinical Data Coordinator-Project Leader 01/1996 to 01/1996 SmithKline Beecham Collegeville, PA
  • CDM.
  • Therapeutic Areas: Oncology, CNS, GI, and Cardiovascular.
Contractor 01/1995 to 01/1996 IMS Plymouth Meeting, PA
  • Longitudinal Database Monitor/Medical Coder.
Relief Charge Nurse 01/1995 to 01/1995 Lutheran Deaconess Community PA
  • Position included supervising care aides and providing direct patient care to the Sisters in the Infirmary of the Motherhouse.
Small Group Coordinator Office Volunteer Coordinator Administrative Assistant 01/1991 to 01/1995 Church of the Good Samaritan Paoli, PA
Manager, Title Abtract Company and Church Law Paralegal 03/1988 to 08/1994 Various - Law office and Church Paralegal West Chester, PA In charge of clearing title reports prior to settlement
Supervised an administrative assistant in preparation of all documents for a real estate closing
reconciled all of the paperwork following the real estate closing
dealt with setting up and maintaining various escrow accounts
worked on the inventory filing for the Orphan's Court for an estate
Have prepared estate and inheritance tax forms as part of my training
As a member of a time established insurance policies for Church property
recommended and subsequently achieved directors and officers liability insurance for the entry of the Church and sexual abuse insurance for clergy counseling sessions
Also recommended that all personnel working at the Church be screened for possible sexual offender background check results 
Attended a church law conference to aid my work with the Parish
In Pharma industry have had training in FDA Law, regulated computer systems validation and following the necessary guidelines as part The Federal Food, Drug and Cosmetic Act and Title 21 CFR
Medical Review Specialist 01/1989 to 01/1991 Intracorp Plymouth Meeting, PA
  • Duties included telephonic medical utilization review.
  • Participation on a committee for development of guidelines for review of lengths of stay for various diagnoses.
Assistant Utilization review Supervisor 01/1988 to 01/1989 Quality Health Services Plymouth Meeting, PA
  • Duties included telephonic medical utilization review.
  • Supervision of review staff-both Nurses and Clerical Staff.
  • Training staff on guidelines for review of lengths of stay with various disease states.
Registered Nurse 01/1981 to 01/1985 Lankenau Hospital Overbrook, PA
  • Orthopedic and Neurosurgery, multiple trauma.
Sr. Data Manager RPR
  • Therapeutic areas: Cardiovascular and Oncology gene therapy.
  • Collaborated on protocol authoring for oncology and cardiovascular gene therapy.
  • Data Manager for Phase I and II protocols in both Oncology and CV Gene Therapy Protocols included: database design and set-up, CRF and edit check design, patient profile design, clinical data review and coordination with the lab responsible for our PCR/IHC testing.
  • Trained/supervised data entry staff as well as junior members of the department.
Education
B.S: Nursing Villanova University College of Nursing Villanova, PA Nursing
Certificate: General Paralegal Studies Main Line Paralegal Institute Wayne, PA General Paralegal Studies
Regulatory Affairs/Quality Assurance 3 courses Computer Validations in a Regulated Environment GPX Audits FDA Law 2013 - UMUC - MS Management Homeland Security Credentials Professional Nursing License, Pennsylvania Board of Nursing Licensed Registered Nurse August 2012- Certified Clinical Data Manager (CCDM) - Society of Clinical Data Management Temple University Graduate School of Pharmacy Fort Washington, PA
Affiliations
Drug Information Association Membership in two SIACs-Data Management and Med. Terminology (MedDRA) Society for Clinical Data Management American Society Clinical Oncology Oncology Nurse Society Member of 6 SIACs and article/abstract reviewer for publications American Chemical Society American Association Critical Care Nursing Regulatory Affairs Professional Society Food, Drug and Law Institute Association of Clinical Research Professionals * Associate Member of the ABA * Member of AALNC * The Paralegal Group
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This is a real resume for a Lead CRS Clinical Data Reviewer in Sellersville, Pennsylvania with experience working for such companies as Cmi, Celgene Corporation 15, Astellas Pharma. This is one of the hundreds of Lead CRS Clinical Data Reviewer resumes available on our site for free. Use these resumes as templates to get help creating the best Lead CRS Clinical Data Reviewer resume.

Previous Companies:

  • CMI
  • Celgene Corporation 15
  • Astellas Pharma

Previous Job Positions:

  • Lead CRS Clinical Data Reviewer
  • Consultant Principle Data Manager
  • Pharmaceutical Consultant
  • Study Trial Manager
  • Clinical Project Data Manager

Schools:

  • Villanova University College of Nursing
  • Main Line Paralegal Institute
  • Temple University Graduate School of Pharmacy

Level of Education:

  • B.S
  • Certificate
  • Regulatory Affairs/Quality Assurance 3 courses Computer Validations in a Regulated Environment GPX Audits FDA Law 2013 - UMUC - MS Management Homeland Security Credentials Professional Nursing License, Pennsylvania Board of Nursing Licensed Registered Nurse August 2012- Certified Clinical Data Manager (CCDM) - Society of Clinical Data Management

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