Clinical Affairs, Pharmacovigilance, Clinical Project Manager - Health
Clinical Affairs, Pharmacovigilance, Clinical Project Manager - Health
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Clinical Affairs, Pharmacovigilance, Clinical Project Manager Resume

Desired Industry: Healthcare SpiderID: 79287
Desired Job Location: California, California Date Posted: 5/16/2017
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 80000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel:
Highest Degree Attained: Masters Willing to Relocate: Yes


Multifaceted, performance-focused, and highly dedicated professional with knowledge and experience in all aspects of medical

education, as well as research and development field. Skilled at collaborating with all members of the organization to meet and

exceed goals. Adept at providing innovative solutions to arising conflicts. Expert at understanding various protocols, policies,

and procedures. Additional qualifications include:
Armed with proven record in working within various therapeutic areas including, cardiovascular disease, women’s health, pain

management, Alzheimer’s, and Diabetes
Knowledgeable of good clinical practice standards (GCP) and FDA
Known for leading the research, design, and implementation of multiple researches


Research Experience

Confidential | Laguna Hills, CA
Confidential 2016–Present
Render support to the principal investigator (PI) in developing training materials and tools involved in the study of issues related

to protocol requirements, visit schedules, and research plan execution
Respond to audit findings and carry out approved recommendations through effectual collaboration with the PI and the organization
Fulfill a wide array of tasks including organizing IRB and other regulatory submissions; assessing protocol; and participating in

investigator meetings
Efficiently prepare study materials that included informed consent documents, case report forms (CRFs), enrollment logs, and drug or

device accountability logs as well as study files such as regulatory binders, study-specific source documentation, and other

Produce a categorized budget and justification by partnering with both PI and the department
Take charge of registering participants in appropriate coordinating center, as well as in the billing matrix to guarantee billing of

study procedures to the appropriate funding source
Gather and submit relevant documents, such as FDA Forms 1572 and curriculum vitae, to the sponsor to commence research
Ensure the completion and arrangement of secure storage for study documents encompassing source documentation, narrative notes, as

well as case report, consent, and investigational material accountability forms; while maintaining adherence to sponsor requirements

and university procedures.
Establish regular communication with sponsor, research participants, and PI during the course of the study
Render support to the principal investigator in performing the following tasks:
Problem resolution, communication, and protocol management;
Alignment of scientific and reporting requirements with federal regulations and agency policies; and
Submission of accurate and on-time closeout documents to applicable federal agencies.
Hold full accountability in screening subjects for eligibility using protocol-specific inclusion and exclusion criteria and

recording each potential participant’s eligibility or exclusion
Facilitate informed consent process, from communicating with (IRB) to organizing discussions with research participants and

answering any questions related to the study
Assure all key personnel that all research project requirements adhere to federal regulations and sponsoring agency policies and

Evaluate and develop familiarity with protocol, including study proceedings and timelines, inclusion and exclusion criteria,

confidentiality, and privacy protections
Process study requirements of all individuals involved in current study

Career Highlights:
Optimized operational efficiency by identifying process issues and developing strategic recommendations for improvement at 3

different sites
Successfully managed the top enrolling site for a clinical trial at 3 different sites and currently maintain top enrollment for

these 3 sites

Emergency Medicine Network (EMNet) | Boston. MA
Research Coordinator 2013–2015
Presided over follow-up English and Spanish interviews with participants of the WIND study
Applied keen attention to detail in monitoring long-term participation schedule

Teaching-Related experience

Massachusetts College of Pharmacy and Health Sciences (MCPHS University) | Boston, MA
Graduate Teaching Assistant (Pharmaceutical Compounding Instructor) 2014–2016
Held accountability in creating various presentations and enforcing classroom etiquette
Provided attention and better support learning through direct coordination with 40 laboratory students
Spearheaded pharmacy student in significant aspects of laboratory compounding and industrial pharmacy

Harvard Medscience |Boston, MA
Mentor 2013–2014
Assisted anatomy and physiology classes by imparting knowledge on simulation laboratory to stimulate interest among science and

medicine and high school students
Drove efforts in inviting students in working laboratory to present real-life examples to inspire underprivileged kids to work

toward careers in science



Master of Science in Pharmacology: 2016
Massachusetts College of Pharmacy and Health Sciences (MCPHS) University, School of Pharmacy | Boston, MA
Howard J. Jenkins Scholarship Fund | Dean’s List

Bachelor of Science in Medical Molecular Biology: 2014
Massachusetts College of Pharmacy and Health Sciences (MCPHS) University | Boston, MA
Merit Scholarship | Dean’s List



Areas of Expertise

Data Analysis | Project Management | Specimens and Samples Preparation | Patient Relations
Training and Development | Clinical Research Regulations

Additional Information:

Technical Acumen

Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
Clinical Trial Management System (CTMS) | eTMF (electronic Trial Master file)
Clinical Trials

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the

Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women.  Retrieved from (Identification No. NCT02691494).
A Placebo-controlled Trial (Part 1) or Active-controlled (Part 2) of SABER® Bupivacaine for the Management of Postoperative Pain

Following Laparoscopic Cholecystectomy. Retrieved from (Identification No. NCT02574520).

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment with BELVIQ

(Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and

Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors. Retrieved from

(Identification No. NCT02019264).

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the

Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects with a Recent History of

Moderate to Severe Chronic Low Back Pain Currently Treated with Opioids.  Retrieved from (Identification

No. NCT02946073).

A Multicenter, Randomized, Double-blind, Controlled, Comparative Study of SI-6603 in Patients with Lumbar Disc Herniation (Phase

III). Retrieved from: (Identification No. NCT01941563).

A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III). Retrieved from (Identification No. XXXXXXXXXXX).

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of XXX-XXX in

Patients with Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) due to Menopause.  Retrieved from (Identification No. XXXXXXXXXXX).

A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker,

and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study). Retrieved from

(Identification No. NCT02245737).

Available upon request.

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