Project Manager Management

ABHINAVA K. REDDY

*** ****** **** ***** : *************@*****.***

Frederick MD 21703 Cell : 240-***-****

CAREER PROFILE:

Proactive, performance driven professional with over 11 years of experience working in Contract Research Organizations (CRO) specializing in Pharmaceutical areas such as regulatory affairs, insurance, manufacturing, data management, inspection, licensing, validation, procedure/protocol development, documentation, management and related services as per FDA, cGMP, GCP, NCPDP standards, HIPPA and 21 CFR regulations. Proficient with Phase I, II, III & IV clinical research. Very IT savvy with knowledge working on several platforms. Articulate leader well versed in developing strategic roadmaps in collaboration with senior leadership to develop, plan, and implement innovative solutions to exceed levels of patient care and management. Keen understanding of business priorities, genuine team player committed to managing operations and projects flawlessly. Recognized for consistent success in developing processes and procedures to streamline operations and enhance revenue performance. Serve as a subject matter expert regarding medical, pharmaceutical and technological innovations to support excellence in advancements in service, care and patient management. Generate consensus for the practical application of new ideas and best practices.

EDUCATIONAL QUALIFICATION:

1. Master of Science in Biomedical Engineering,

Aachen University of Applied Sciences, Germany

1. Bachelor of Pharmacy

Gulbarga University, India

1. Post Graduate Diploma in Hospital Management

UKCBC, London, United Kingdom

PROFESSIONAL TRAINING CERTIFICATIONS:

1. Issued by NIH (National Institute of Health)

1. Protecting Human Research Participants

2. Information Security Awareness

3. Privacy Awareness

1. Issued by Duke University

1. Good Clinical Practice

1. Attended several Pharmaceutical Trade Shows

PROFESSIONAL EXPERIENCES:

EMINENT Services Corporation

7495 New Technology Way, Frederick, MD 21703

Designation: Project Manager

Period: 09/2007 - till date

Clients: National Institute of Health (NIH), Shire, EMMIS Corporation, Collegium Pharmaceuticals

Projects: Protocols from ITN, CTN, DAIT, NIAID etc.

Responsibilities:

1. Held project lead role in Planning, Designing, Analyzing, Evaluating, Testing, Monitoring, Budgeting and Coordinating several clinical study protocols. (Phase I, II, III & IV)

2. Develop study protocols through diverse analytical and statistical studies considering Trials, Tests and Errors.

3. Validation of the manufacturing process in compliance with the regulatory requirements.

4. Establish product specifications.

5. Data Management: Create weekly/monthly documentation for shipping, receiving, labeling, batch record storage, and inventory logs for the billing of services provided to individual clients used SharePoint web application integrated with MS Office suite.

6. Acquired data with queries using SQL (Structured Query Language) from various database’s such as MS Access, Oracle using SQL Developer tool, Also used Excel, Power Point as required.

7. Coordinated the development of double blind and single blind clinical study medications.

8. Coordinated the development of randomized clinical study medications.

9. Coordinated stability studies over prolonged period of times.

10. Trained team members newly adopted procedures, implement and monitor the development of new pharmaceutical products in a systematic way through review mechanism, validations and monitoring schedules.

11. Work on specialty packing configurations, design and development of containers for clinical trials, temperature controlled products, time sensitive products and controlled substances.

12. Manage regulatory affairs, quality assurance, and production coordination with purchase, marketing, production, and standardization teams for launching new products as per schedule.

13. Familiarized with all Repository activities such as handling, dispensing and monitor clinical site level inventory of clinical supplies and biological samples.

14. Familiar with most of the customs regulations, documentation for international shipments for biological as well as clinical samples.

15. Participated in several internal and external (Clients) audits.

16. Designed and drafted Standard Operating Procedures (SOP’s), Batch Records, Logs, Protocols and Medication Labels (Open, Single Blind, Double Blind and Randomized Study Medication).

17. Reviewed and approved process deviations, non-conformances and change controls.

18. Investigated client/site complaints, rejection analysis, training and audit compliance.

19. Perform physical inventories every quarter to monitor inventories of all the respective clients.

20. Intense knowledge in inventory management, tracking of patient specific study medication, logistics, storage, temperature monitoring, security as per DEA regulations, ordering, mail order pharmacy, vendor qualification, licensing, permits, controlled destruction, etc.

21. Communicate with clients on day to day activities, attend weekly, bi-weekly, monthly and quarterly meetings through conference calls.

22. Worked on Mail-Order-Pharmacy where I dealt with Medicare, Medicaid, Part-D, Rx Services, Co-Pays, Deductibles, Health plans, and Insurance providers.

23. Managed adverse event information associated with the use of different medications using Medical Dictionary for Regulatory Activities (MedDRA), WHO Drug Dictionary (WHODD), EDC, EMR, HIT etc.

24. Developed disaster recovery plan during systems failure.

25. Developed drug recall procedures and implemented.

26. Safeguarding privacy by maintaining confidentiality of information. Familiar with EPIC guidelines.

27. Attend regular professional development programs to familiarize with Current Good Manufacturing Practices (cGMP), Regulatory affairs and Regulations.

Pelgrow Limited

82-86 Sheen Road, Richmond, London, United Kingdom - TW9 1UF

Designation: Research Associate

Period: 02/2004 to 07/2007

Responsibilities:

1. Development and preparation of protocols for clinical study products.

2. Assist in the performance testing of pharmaceutical preparations such as tablets, capsules, liquid orals and parental formulations.

1. Development and validation of analytical methods.

2. Storage, Distribution, and return drug handling of investigational drugs, biological samples and controlled substances through a DEA approved cage.

3. Clinical study product accountability, reconciliation and destruction as per EPA and regulatory requirements.

4. Design and development of Specialty Packaging Configurations for clinical trials.

5. Bulk drug dispensing of clinical supplies and clinical site level inventory monitoring.

6. Manufacturing of matching active and placebo drugs in the development of pharmaceutical formulations.

7. Development of packaging of double blind and single blind clinical study medications.

8. Participate in investigational drug development programs.

9. Worked as an active team member of the Pharmaceutical Research & Development team and participated in investigational drug development programs.

Medak Nursing Home

512, M.G. Road, Medak, Andhra Pradesh, 502110 – India

Designation: Pharmacist

Period: 01/2001 to 02/2002

Responsibilities:

1. Wrote policies and procedures for safe and effective drug dispensing in accordance with laws and regulations and was also responsible for the safe and efficient dispensing, control, security, and accountability of drugs.

2. Responsible for rounding the hospital with the medical team to provide consultations on drug therapy.

3. Responsible for managing and filling high volume (600-800) prescriptions serving hospital and community beneficiaries.

4. Ensure that pharmacy operations are in compliance with federal, state and regulatory bodies.

5. Administration of pharmacy benefits services including insurance prior authorization and patient assistant programs.

6. Handled quality control, storage of controlled drugs, data management, prescription record keeping, medical cost management and day-to-day issues.

7. Training/Educate Pharmacy Technicians and other health care professionals at the hospital, as part of their Continuing Educational Program.

8. Provided counseling on the prescription and non-prescription drugs.

9. Responsible for inventory management.

10. Safeguarding privacy by maintaining confidentiality of information.

11. Actively participated in Continued Professional Development Programs (CPD).

References: Available on request

Thank you

Abhinava K. Reddy – Cell 240-200-4982Page of 3

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