1. BANGALORE KAMALA M. Mgt, CTRC, CCTA, CPMCR 781-861-9851(H)
Kamalab1130@gmail.com
781-354-4082 (Cell) Lexington MA
KEY Knowledge and Experience:
ICH-GCP Guidelines Metrics and Data Analysis Protocol Training
Vendor Management-CROs Clinical Project Management SOP Review
Site Monitoring-CRA
Study startup to close out study
Working with cross functional team
Strong Organizational Skills
Audit Inspection Readiness
Investigators meeting
Monitoring Patient
Regulatory binders
Managing Clinicaltrial.gov
Clinical Trial Master file
Registry & Timeline
Recruiting PI-Site-Patient
Budget and Resourcing
Customer care
Reimbursement-Medicare
WORK EXPERIENCE-BIOGEN Cambridge MA
Global Clinical Operations-Clinical Trial Transparency- Sr. Communication Project Associate (Contract) Apr 2014 - Current
Lead point of contact for business focused public communication questions from Patient, PI, SMOs, CROs and others like Business inquiries from across the country and globally.
 Global experience leading phase I – IV clinical programs and subject recruitment.
 Communicating Clinical Trial Transparency to enable accurate processing and tracking of public inquiries (ClinicalTrials.gov) regarding ongoing or completed clinical
research. Tracking, data entry, training and report metrics on query types and response times. Clinical Research Data Associate will assist with the creation and
validation of electronic case reports
 Review and evaluate clinical patient data using electronic data capture system
 Review site reported data elements, generate manual queries, resolve answered queries
 Processed responses to ensure compliance with various reporting requirements identify and es calate issues as needed.
 Provide operational leadership for assigned projects with a clinical development program
 Audit and QC for German inspection document tracking and updating on spreadsheet.
 PI, CRO and patient email inquiry response and track inquiries for site selection and study startup, data collection
 Protocol Registration. Created check list for requesting response to protocol registration
 Created training materials and process documents (e.g., Standard Operating Procedures, Work Instructions, etc.)
 Track and report on progress of study metrics including but not limited to site activation, patient enrollment and monitoring visits reports Working with Physicians
to enroll patient to the study and recruiting sites
 Familiar with the clinical development life-cycle, (AE reporting, study milestone tracking, regulatory submission process etc.) supporting information/data sources
and systems (Clinical Trial Management System CTMS, electronic Trial Master File eTMF, health information privacy rules, and data from source systems
 CTT Website Admin Tool QC and QA for new product published and on Clinicaltrial.gov website and review and tracked all CRFs
 Tracking FPI and LPO from information PDP, IMPACT, Vision Tracker, BRASS and ShareNet
 Report Metric to the Team CTC, CTA and BIIB Corporate both Internal and External stakeholders on monthly basis
 Lead clinical trials communications to thousands of internal/ external stakeholders, developed standard forms and procedures for reporting inquires. Built reports
and dashboards tracking all clinical trial inquiries
 Familiar with the CTMS, CTT, FPI and LPO. Organize training all-hands and off-sites for a global team of 30+ individuals
PARAXEL (CRO), Billerica, MA: Sr. Clinical Trial Project Manager (Contract) Sep 2013 – Apr 2014
 Project Manager for tracking and reviewing clinical trial agreements: QC, contracts, budgets, reporting, end of study activities
 Project Manager for clinical site activities: identification, qualification, SRP, SIV and relevant site initiation processes
 Reviewed Investigator Site Files, tracking all clinical trial materials from start to end of clinical trial, ensuring QC and diligence of privacy, storage and proper
assignments
 Provided general support for the Clinical Trial Managers in their daily activities, such as; EDC report generation, enrollmen t updates and vendor management
SHIRE HGT, Lexington, MA: Project Manager: Orphan disease therapeutics for Philanthropy and Patient services (Contract) Mar 2011 – May 2013
 Researched alternative funding programs for eligible patients.
 Worked with Sales and Marketing, as well as clients, vendors, and business relations teams both in domestic and international teams/organizations as the contact
person for participating sites. Maintained Project File timeline using MS project
 Tracked charity requests, import licenses and related patient information and uploaded into SharePoint for CTMS.
 Worked with other Trial Master File and Quality and Control Inspection teams to support Clinical Trial audits and inspections .
 Reviewed TMF completeness at a high level, identified trends in the organization using the eTMF reporting tool. Functioned as TMF process subject matter expert to
study teams.
 Managed project for orphan disease therapeutics: philanthropy and patient services, tracking the clients, vendors, and business relations teams.
 Global experience leading phase I – IV clinical programs and subject recruitment.
 SAE review, informed consents, IB reviews, Protocol reviews, CRO management, Investigator meetings, Regulatory submissions
 Tracked charity requests, import licenses and patient information stored in SharePoint.
 Subject Matter Expert for TMF: identify trends using eTMF reporting tools
Assistant Case Manager/Care Coordinator/Commercial team
 Clinical trial supply ordering and tracking
 Maintained case history and relevant data for all assigned patients in the CTMS system.
 Externally communicated to patients, insurance and sales teams, providing ongoing compliance and documenting outcomes.
 Tracked drug shipments and coordinated with the pharmacy and drug supplier.
 Assisted patients with Patient assistance programs (PAP) and financial assistance information.
Clinical Document Associate/Data Records Specialist
 Coordinated department audits, mock inspections, FDA Inspections
 Managed QC Review of pre-study and study documents: maintain document tracking system
 Collaborating with CTM to determine to issues in regulatory documentation and create study specific document checklists in co llaboration with the CTM and
medical research
 Tracked key clinical trial activities including: drug shipments, status reports, study visit logs and subject databases as needed and ensure accuracy. Performed,
organized and QC the development and execution of internal and site audits.
FoldRx Pharmaceuticals, Cambridge, MA: Sr. Clinical TMF Document Manager (Contract) (Pfizer) Nov 2009 – Mar 2011
 Coordinated in-house monitoring activities, and records management for TMF
 Collected, QC’d, maintained and tracked regulatory documents for FDA inspections.
 Conducted internal audits and tracked country specific regulations for the CRO (ICON) vendor files.
 Tracked key clinical trial activities including: drug shipments, status reports, study visit logs and subject databases as needed and ensure accuracy. Managed all
study documents, Trial master files at the site and at the CROs
 Tracked changes to clinitrial.gov, invoices, site payments, protocol deviations.
 Oversee clinical Trial Master File and maintain it for inspection-readiness/due diligence activities.
 Tracked site Feasibility questionnaires, central lab samples and coordinated pharmacy supplies
 Participated as a data manager for collecting data FPI and LPO, tracking and review of all trial data.
 Prepared audit inspection and communicated with the site for the CRO updates on sites and patients visit

2. Cambridge University, UK: Project Coordinator-Patient Recruitment for Diabetes, Obesity and Heart Disease studies-India Sep 2009 – Nov2009
Vertex Pharmaceuticals, Cambridge, MA: Sr. Clinical Operations CRA Dec 2008 – Sep 2009
 Maintained and tracked IRB Issues/resolution log, protocol review, PI information update tracking as well as trained SOP/GCP, interacted with sites, CROs and CRAs
to obtain timely updates.
 Reviewed tracked and uploaded QC regulatory documents and prepared regulatory binders for the sites. Uploaded study specific pub-med publications to
SharePoint. Verified clinical trials data through Oracle database
 Registry collecting patient data after the study. Global experience leading phase I – IV clinical programs and subject recruitment.
 SAE review, informed consents, IB reviews, Protocol reviews, CRO management, Investigator meetings, Regulatory submissions
 Communicated and managed CROs budget and track all study payments, Timelines
 Tracked all projects and feasibility updates for clinical trials, PI & Patient communication
 Assisted in the planning of investigator meetings, recorded, and distributed meeting minutes
 Assisted clinical project manager in site management activities, including review of monitoring report, tracking of site vis its, communicated with monitors, Vendors
and sites in-house monitoring managing timeline for the study using Microsoft project; attended and participated in study team meetings
Wyeth Pharmaceuticals, Cambridge, MA (Pfizer) Apr 2005 – Nov 2008
Ex. Clinical Associate/Sr. Clinical Research Study Coordinator Oncology/Sr.Quality Control Audit Specialist
 Conduct monitoring to verify accuracy of study data vs. source records. Ensure HIPAA requirements for patient privacy are met. Ensure no study tasks are conducted
prior to IRB/EC approval, CDA/FDA approval, and formal site activation. work details of study budgets and contracts with sites
 Communicated-point contact person for CROs and site on clinical studies manage payments and invoices related to projects – study assigned. Patient Narrative
development and Registry follow up
 Generate study documents such as Case Report Forms and CRF completion guidelines, SOP Review and update
Collect study documentation from site such as completed CRFs, Investigator Agreements, Investigator CV’s and licenses, training forms, protocol deviations, queries,
adverse event reports, etc.
 Build and maintain tracking sheets to track progress of sites to initiation, enrollment and screening, interim monitoring, an d close-out requirements. Maintain
documentation in electronic and paper Trial Master Files
 Maintain close communication with study sites, investigators, and vendors to execute the trial in accordance with the protocol, study timeline, and study budget
and timelines
 Conduct Contract research organization(CRO) and Site Qualification Initiation, Interim Monitoring, and Close-out visits and write corresponding visit reports, as
needed. Provide oversight of contract monitors including co-monitoring
 Ensure adverse event reporting is done in accordance with regulatory requirements. Verify the accuracy of study results
 Created and maintained clinical documents protocol, amendments, summary of change documents, ICFs, CSRs, SAE patient narratives and summaries
 SAE review and reconciliation, informed consents, IB reviews, Protocol reviews, CRO management, Investigator meetings, Regulatory submissions. Global
experience leading phase I – IV clinical programs and subject recruitment.
 Supported study teams around business process needs such as Investigator meetings/Kickoff meetings/vendor coordination meeting. CDAs, safety letter tracking,
insurance procurement. Patient safety cards, diary and printing.
 Site SOPs, clinical trial agreement, clinical trial budget, site evaluation, trial evaluation, patient recruitment and site managing
 Managed study activities and developed study documents TMF, Protocols, IBs, CRF, ICFs and Contracts
 Managed and tracked key clinical trial activities including: drug shipments, status reports, study visit logs and subject databases as needed to ensure accuracy.
Protocol registration, QC, invoices, site payments, drug shipment and retrieve unused drugs
 Tracked invoices, payments, and corresponding purchase orders, wrote budgetary reports for financial updates
 Tracked SAEs and initial, follow-up and final reports for phase I through phase III trials.
 In-house site monitor: trained sites on protocol, patient narratives, processed safety letters and regulatory documents/binders to sites, TMF, and drug shipment.
Managed study timelines using Oracle clinical and Oracle procurement
 Point person for FDA inspection and internal audits
COMPUTER EXPERIENCE
Parametric Technology, (Computer Customers Technical Support Specialist) Good Communication skills, Competent with Microsoft office, Documentum, FirstDoc, ISI Toolbox
and Adobe Acrobat, MS Project, MS word, Windows, Power point, Oracle database for tracking, Access, Outlook, Excel, HTML, IDX , EDMS, SharePoint, CTMF, Intralink. Oracle
clinical remote data capture training.
Healthcare Billing Experience: Certified in medical billing - CPT coding, Anesthesia coding and UB92. Managed care experience with Multiple Insurance Companies Commercial,
Medicare and Medicaid.
EDUCATION
Project Management in Clinical Research-Vendor Management Certificate program: Boston College, Brighton
Masters in Management (M. Mgt): Specialized in Healthcare Management
Project Management in Business: Cambridge College School of Management, Cambridge: Course work completed
Project Management Institute of Boston: PMP course work completed.
Institute for Health Information Certificate: Completed the Human Subject Assurance training, Module 1 and Module 2, Medical Terminology I & II; Risk management and
patient safety certified, Medical Assistant, EMT, CPR certified, trained phlebotomist. GCP certified
Boston College: Certificate: Pathways in Clinical Trial Research, Vendor Management, Clinical Research Statistics and Foundations to Clinical Trials- CCRC
Massachusetts Biotechnology Council (MBC): Certificate: Clinical Trial Research - CTRC
Harvard University Extension School: Certificate program in Healthcare Management and Administrative Policy, Planning and Operations- Courses: Marketing Services, Strategic
Management in Healthcare Organizations, Human Resource Management. Microcomputers and Information Technologies, Electronic Communication as a Management Tool,
Project Management, Leadership and Power in Organization, Healthcare Finance
Southern Connecticut State University: (Bachelors in Special Studies & Premed courses, Accounting, Genetics, Chemistry, Biology and Statistics, anatomy and Physiology)
Administrative training- Microsoft and Microsoft project
Bangalore University: Bachelor of Arts in Psychology, Sociology, Economics and History