OBJECTIVE

To work in a result oriented company that seeks ambitious and career cautious person where my skills and innovative ideas will be beneficial for the growth of the company.

• 3 years of experience in Clinical Data Management involving clinical coding, validation and programming.
• Leveraged my six years of Pharmacy education (Bachelors in Pharmacy and Masters in Pharmacy) in clinical data management for various Fortune 500 clients.
• Coding experience on various diseases like Oncology, Chronic Pain, Anemia due to chronic Kidney Disease, Osteoarthritis of Knee, Acute Coronary Syndrome, Acute Pain due to hip replacement, Chronic Low Back Pain, Schizophrenia, Diabetic Peripheral Neuropathy, Post Therapeutic Neuralgia, CLE, SLE, HRPC, Relapsed or refractory multiple myeloma, Rheumatoid Arthritis, RA, MTX therapy, PsA, AS, Ulcerative Colitis (UC), Plaque Psoriasis, Crohn’s disease, Hereditary Angioedema etc.
• Phase forward certified for InForm 4.5 CDM Modules.
• Extensive experience on dsNavigator tool for medical coding.
• Experience on OC platform, CRF designing.
• Basic Knowledge of SQL to populate the information from the database.
• Expertise in using WHOART, WHODD, MedDRA
• Contributed to enhance the WHO DRUG Dictionary during the year 2008.
• Registered pharmacist under Indian State pharmacy council.
• Presented various papers in national level seminars.
• Regional level mathematics Olympiad qualifier.
• US Permanent resident (Green Card Holder)
• Willing to relocate.

SKILL SET

• In depth knowledge of dsNavigator, InForm, OC.
• Hands on experience on instruments like-
• U.V-Visible spectrophotometer (SHIMADZU-1601),
• FTIR (Perkin Elmer),
• HPLC
• Usage of Pharmaceutical Chemistry related software like Chemical sketch, ISIS Draw.
• Languages known: C, C++, Basic.
• Operating systems: Windows 98/XP, Vista
• Hands on experience with Microsoft Office, Excel, Power Point etc.

ACADEMIC HIGHLIGHTS

Total six years of pharmacy education from Confidential colleges

Master of Pharmacy, major in Pharmaceutical Chemistry, from Confidential University

Bachelor of Pharmacy from Confidential University

Certificate course in Clinical Research (CCCR) from Symbiosis Centre of Health Care 
(SCHC).

WORK EXPERIENCE

Confidential Research Coordinator-II(Clinical Data Manager)
September 2010 – May 2011

The responsibilities of the Research Coordinator II include, but are not limited to:

• Review sections of study protocols related to patient treatment, supportive care, specimen submission, patient follow-up, and any other sections requiring understanding of clinical or laboratory aspects of COG studies.
• Working as Lead Clinical data manger and managing the team of Research Coordinator I.
• In collaboration with the study statistician and study committee, design the draft Case Report Forms (CRFs) and data validations required to collect the necessary research data for COG studies.
• Create new group data elements (GDEs) as needed to capture essential research data for the study, or identify required GDEs from the existing GDE database, following established guidelines and procedures.
• Based on finalized CRFs, implement data elements and data validations for the Enhanced Remote Data Entry System (eRDES) through the Study Manager application. Complete testing, refinement, documentation and release of these screens adhering strictly to the established development procedures.
• Manage the conduct of studies including, but not limited to, monitoring patient enrollments and randomizations and closing or suspending studies as determined by protocol design or Study Chair to ensure patient safety. Create and execute the Study Data Review Plan according to established procedures.
• Monitor the quality of submitted research data through the eRDES reporting module to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data. When necessary, modify or enhance data validations to prevent and correct data errors and omissions that have been identified.
• Set up and monitor systems for rapid tracking and reporting of dose-limiting toxicities, toxic deaths, severe adverse events (SAEs), treatment failures, or other critical study endpoints, as appropriate for the study.
• Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.

Confidential Clinical Data Analyst(CDM)
October 2009- May 2010

Client -Confidential

• My role in Parexel is to independently act as Clinical Data Manager and perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Key activities include data validation, generation and integration of queries, coding of clinical data, reconciliation of safety and electronic data.
• User Acceptance Testing of the study.
• Assume the ability to meet the requirements of a CDA I with a high degree of proficiency and autonomy
• Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
• Train team members on selected tasks
• Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
• Manual and Patient Profile review, issue queries
• Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
• Track and integrate queries
• Interact with site (via mail) as required
• Coding of conmeds and adverse events.
• Inform responsible CDA Coordinator of work status regularly
• Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.

Confidential, Clinical Data Manager 
January 2008- September2009

Client: Confidential 
Clinical Data Manager (Medical Coder)

• Coding of clinical data through dsNavigator.
• Perform Clinical Data Management tasks.
• Perform coding of terms using medical dictionaries like Med DRA, WHO DD etc.
• Recorded appropriate code for Adverse Events, concomitant/therapies and medical conditions.
• Maintain issued product-specific reference lists while coding AEs, medications and medical conditions.
• Attend weekly Clinical Project Team meetings.
• Ensure codes within database are accurate.
• Manage auto-encoding processes and encoded all data requiring data management milestones
• Accountable for accuracy, consistency and completeness of all required encoding changes prior to DB lock.
• Review all encoded terms for accuracy and consistency within clinical studies and across clinical programs.
• Resolve inconsistencies noted.
• Maintain global terms and synonym tables.
• Code drug information in system
• Code adverse events, lab data, medical history, surgical procedures, and disease terms in dsNavigator and perform QC Steps.
• Responsible for overseeing dictionary maintenance and performing
• Performance of Data Management tasks.
• Perform other duties directed by the Lead Data Manager or Functional Manager.
• Review of protocols.
• To write and resolve Data clarifications.
• Develop and maintain good communications and working relationships with CDM team.