Clinical Project Manager - Healthcare Resume Search
Clinical Project Manager - Healthcare Resume Search
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Clinical Project Manager Resume


Desired Industry: Healthcare SpiderID: 71282
Desired Job Location: Burlington, Massachusetts Date Posted: 1/16/2014
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 95000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel:
Highest Degree Attained: Bachelors Willing to Relocate: No


Objective:
Analytical, dedicated, and seasoned
clinical research professional, with 11
years of extensive experience in global
clinical research within pharmaceutical
and medical device industries. Monitored
Phase I-Phase IV clinical trials in
accordance with FDA, GCP's, CRO and
Sponsor guidelines and SOP's. Adept at
managing clinical research projects,
including communication with clinical
sites, initiation, monitoring, adverse
event reporting, proper collection of
clinical data, and other related
activities. Known as an exceptional
employee and contributor to the
company’s bottom-line; team player with
solid commitment to sharing knowledge to
attain corporate goals Armed with time
management, written and verbal
communication, and interpersonal skills
necessary to easily interface with the
management, vendors site staff, and
other clinical research professionals


Experience:


PROFESSIONAL EXPERIENCE
BIOGEN IDEC, CAMBRIDGE, MA, USA
Clinical Project Manager, Global
Clinical Operations (Contract) Jun–Dec
2013
Provided oversight to cross-functional
project teams derived from the groups
within clinical development to deliver
high-quality clinical trials. Supervised
and supported Drug Safety Review
Committee of two studies and performed
various duties, including selecting
DSRC members; compiling contracts of
members of the DSRC; gathering and
reviewing safety data; producing
datasets to be reviewed; setting up DSRC
calls and meetings; and conducting data
and follow up with the site to get
additional information about missing
data of AE/SAEs. Developed and
maintained Drug Safety Review Committee
charter and ongoing data review plan
(ODRP). Worked closely with members of
ODRP and rendered datasets, tables, and
listings. Conducted proper review of
protocol, source documents, and CRFs;
tracked them to completion. Spearheaded
all aspects of the clinical project
management process from initiation,
planning, execution, control, and
closure. Participated in investigator
meeting (IM) and DSRC meetings and
reported detailed presentation about
progression and updates of data.
- Streamlined the process of ICF
review of global clinical trials as
assigned by clinical operations lead
(COL), including MVR review as assigned
by COL
- Managed vendors working on the
study by identifying and resolving any
issue as applicable
- Reviewed and verified essential
documents of United States as well as
international sites in order to activate
sites in IXRS and authorize shipment of
investigational product (IP) to the
sites

ORA INC., ANDOVER, MA, USA
International Clinical Project Manager
Apr 2010–Jun 2013
Supervised and observed the entire
clinical trial process, including
tracking of enrollment projections and
sites activation. Provided
investigational product supply to the
sites and delivered the project on time
and on budget. Prepared project plans
while maintaining MS Project timelines
for each project to track and manage a
project’s progress. Communicated with
the management regarding study and site
schedules to ensure Sponsor enrollment
timelines were met. Collaborated with
the international CRO partner in
performing clinical trial, including
regulatory submissions, import and
export licenses, ethics committee
submissions, protocol execution at
sites, and monitoring and data
management and statistics. Gathered and
reviewed study-related support materials
created by the Monitoring and Data
Management Groups. Set up periodic
clinical trial team meetings on a weekly
basis. Monitored performance and quality
with the team and management.
- Reviewed clinical trial master
file to ensure maintenance and
completion
- Carried out overall
responsibility to deliver the projects
on time and on budget
- Handled the negotiation of
competing priorities across multiple
functional areas
- Coordinated clinical trial
projects process with key functional
areas
- Served as integral point of
contact for interdepartmental and
intradepartmental groups in a matrix
environment to drive and complete
clinical programs
- Supervised and made sure that
all groups provide deliverables
- Created and presented detailed,
high-quality reports for management on
program status and issues

FOLDRX, INC., CAMBRIDGE, MA, USA
Clinical Project Manager Jan–Mar
2010
Senior Clinical Research Associate
Feb–May 2009
Played a vital role in handling and
executing one ongoing phase II study and
two phase I studies while ensuring phase
I to phase III clinical trials were in
accordance with procedures set forth by
the Food and Drug Administration (FDA),
Code of Federal Regulations (CFR),
International Conference on
Harmonization (ICH) Guidelines, Good
manufacturing practices (GMPs), and Good
Clinical Practices (GCPs), along with
sponsor standard operating procedures
(SOPs). Managed the investigational
sites for qualification, initiation,
interim and close-out visits.
Coordinated Cardiology and Neurology
clinical studies. Generated detailed
reports for the physicians and medical
sponsor team.
- Implemented training for junior
CRAs and CTAs; participated in
conference meetings concerning training
and study status as well as weekly
conference calls; strategized agenda;
and conducted follow-up on
questions/concerns

ARTISAN PHARMA, WALTHAM, MA, USA
Clinical Trial Lead Aug 2009–Jan
2010
Oversaw the development and execution of
large global phase II B study with 190
sites and 750 patients in accordance
with procedures set forth by the FDA,
CFR, ICH guidelines, GMPs and GCPs along
with sponsor SOPs. Coordinated the
sepsis and DIC study.
- Led and facilitated training of
regional CRAs and site staff
- Conducted qualification,
initiation, interim and close-out visits
at the sites

WAVERX INC. WALTHAM, MA, USA
Project Manager Clinical Affairs
Jul–Oct 2008
Contributed to writing clinical study
protocol and supporting documentation,
sections of regulatory submissions,
procedures, and other required
documents. Worked closely with
development team to ensure study plans
align with development and commercial
strategies.
- Created development of study
documents, including study protocols,
case report forms, informed consent
forms, training manuals, reports, and
others
- Led the execution clinical
research projects, including
communication with clinical sites and
provision of product application
support, initiation, monitoring, adverse
event reporting, proper collection of
clinical data, and other related
activities
- Analyzed, determined, reported,
resolved key issues affecting project
completion; provided accurate and timely
reports on study status and user
experience
- Learned and honed product and
clinical indication expertise to
communicate effectively with clinicians

ABT ASSOCIATES INC., LEXINGTON, MA, USA
Lead Clinical Research Associate
Jun 2005–Jun 2008
- Conducted phase I to phase IV
studies as well as post-marketing
clinical trials in accordance with
procedures set forth by the FDA, CFR,
ICH guidelines, GMPs and GCPs along with
sponsor SOPs.
- Performed qualification,
initiation, interim and close-out visits
at the sites.

QUINTILES INC., BOSTON, MA, USA
Clinical Research Associate August
2004– Jul 2005
Adhered to GCP, investigator integrity,
and all study procedures. Oversaw the
SAEs and non-SAEs. Coordinated
collection of information from
investigational sites and developed
training materials for site staff.
- Closely monitored regulatory
status of studies at sites, attending
investigator meeting, reviewing informed
consent forms, case report forms, source
documents, resolving data queries and
quality assurance issues, Drug
Accountability.
- Led the execution of clinical
monitoring in compliance with FDA
regulations and all related SOPs



EARLIER CAREER
BIOPURE, CAMBRIGE, MA, USA
Clinical Research Associate | Data
Management (Contract)
BIOGEN IDEC., CAMBRIDGE, MA, USA
Drug Safety and Medical Information
Specialist (Contract)
AMERICAN RED CROSS, BOSTON, MA, USA
Senior Health and Safety Instructor
GUPTA HOSPITAL, JALANDHAR, PUNJAB, INDIA
Physician


Education:

EDUCATION
Bachelor of Medicine and Bachelor of
Surgery (MBBS)
GOVERNMENT MEDICAL COLLEGE AMRITSAR,
PUNJAB, INDIA

PROFESSIONAL TRAINING
2013 Reviewing essential documents of
global sites in order to activate sites
and authorize IP shipment
BIOGEN IDEC
2008
Successful IRB/IEC Submission
Writing/Reviewing the Informed Consent
ACRP
2007
Advanced Clinical Trials
Monitoring
Adverse Event Monitoring
BARNETT EDUCATIONAL SERVICES
Product Quality Complaint (PQC)
Awareness Training
Reporting Postmarketing Spontaneous
Adverse Events
EDUNEERING
2005
Adverse Event Workshop
QUINTILES
2002 Fundamentals of Clinical
Research, Clinical Research Associate
Education and Training Program
MEDICAL RESEARCH MANAGEMENT, INC.



CERTIFICATIONS
Automated External Defibrillator (AED)
Instructor Certification - Cardio
Pulmonary Resuscitation (CPR) of Adult,
Child, Infant - Occupational Safety and
Health Administration (OSHA) Regulations
- Oxygen Administration


Affiliations:
AFFILIATIONS
Society of Clinical Research Associates
(SOCRA) - Association of Clinical
Research Professionals (ACRP)
Drug Information Association (DIA) -
American Red Cross


Skills:
-----


Additional Information:
CAREER HIGHLIGHTS
- Managed several vendors.
Effectively supervised CRO activities,
including conducting and monitoring
timely sites update, meetings,
teleconferences, and project timelines
and progress
- Directed CRA activities,
including field monitoring, report
writing, site compliance auditing, and
project directive follow-up for drugs
and devices
- Provided expert supervision and
training of six regional CRAs (contract
staff). GCP, ICH and protocol
interpretation and compliance
- Wrote protocols and executed
CRF/source document verification,
database management, and patient profile
review
- Proficiently conducted clinical
studies, particularly in Cardiology
(Migraine, PFO), Neurology, Oncology,
Psychiatry, Pulmonology, Endocrinology,
Infectious Diseases, Sepsis DIC (ICU
Study), Ophthalmology, Otolaryngology,
and Orthopedics
TECHNICAL SKILLS
Microsoft Office Suite, Clintrace SDB,
Clinical Trials Management System
(CTMS), Clintrace Safety Database,
Electronic Data Capture (Oracle
Clinical, DataLabs, Phase Forward and
Mednet), InnTrax, Sharenet, and InForm



Reference:
Available upon request.


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