Post Job Free

Resume

Sign in

Clinical Research Development

Location:
Alpharetta, GA
Salary:
75,000kper year
Posted:
September 02, 2023

Contact this candidate

Resume:

Yaratha S Reddy

Email adze58@r.postjobfree.com phone # 404-***-****

Core leadership Skills and Expertise

Medical professional with over 30 years of experience leading the development and delivery

Of profitable health care throughout the US and India.Combines strong research and administrative expertise as a licencsed medical doctor

Key Career Accomplishments

10 years of academic Medicine, comprehensive transformation 80 bed hospital

Resulting inhospital being ranked number on both clinically and financially within

50 hospital system.

Quality Care

Improved80% of clinical qualitymeasures of 80 bed hospital and achieved top

Quality scores.

Completed several joint ventures between private health care organizations

Resulting in subspeacialty carebeing provided in neighboring areas. 200X

Professional experience

Sitapur Eye hospital 350 beds catering to the needs of one million people in the city

oSitapur Uttar Pradesh India

oObtained DOMS a diploma in Ophthalmology Medicine and Surgery. It is Board certified in India.It is recognized by the British Medical council

Learned many new surgical procedures from Visiting surgeons from Engla

Obtained MD degree from Guntur Medical college Guntur Andhra Pradesh India.It is mentioned WHO directory.www.gmcana org

Worked at Grady Health System Endocrinology divison Atlanta GA

oScreened patients with Eye Diseases after long duration of Diabetes.

oBE a part of Clinical grand rounds of Emory University Ophthalmology division. I

Worked as a Liasion between Endocrinology and Ophthalmology of Emory University.

Referred patients who needed surgery and photo coagulation for retinal diseases

Learned lot new approaches in treatments for AMD ( age related macular disease)

New drugs developed for glaucoma by reading ophthalmology Journals.

Education

Research Experience

Worked along with my associate professor Dr Rekha Goel in a research project Moorens Ulcerand Subconjuctval dislocation of lens due to a bullgore injury.

A paper published in Psychiatic Journal on Diabetes and Depression and how it affects Ocular complications in the long term at Grady Health System Atlanta Georgia. Strong scientific and academic background with deep understanding of retina and eye disease

Clinical research or pharmaceutical experience in ophthalmology

Knowledge of drug development

Good networking ability in cross-cultural environment

Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization

As a Clinical research Coordinator screened patients for drug studies,did follow up

Recognized any sideaffects and warned the pharmaceutuical companies to withdraw

And suspend the study.

Teaching Experience

Educated hospital staff on new drugs in the treatment of glaucoma.Delivered presentations to the rsidents and the faculty of morehouse school of medicine and Diabetes and ocular complications.

Professional Affiliations

Member of AllIndia Ophthalmology Association

Obtained ECFMG certification in USA after passing USMLE exams

Community Service

Organization

Performed operations on Cataract, Glaucoma in the Eye camps conducted by Lions and Rotary clubs.Some projects were supported by OXFAM of England at Campbell hospital

Cuddapha Andhra Pradesh India

Organization

Participated in free camps at the regional and state level giving vision with best surgical procedures. I have deep scientific, technical, and clinical expertise in ophthalmology

Understands and keeps updated with the pre-clinical, clinical pharmacology data

Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products

By attending seminars Ophthalmology associations keep up to date

Knowledge and developments in the clinical field

Languages

List the languages that you know, along with your level of proficiency. Use an appropriate proficiency scale such as the ACTFL which provides guidelines for Novice, Intermediate, Advanced, Superior, and Distinguished levels in Listening, Speaking, Reading, and Writing.

Telugu Hindi and English proficient .Currently learning Japanese

Other

Love reading books,listen to music.

Citizenship

Main responsibilities:

Some of the Clinical Research Director’s (CRD) core job responsibilities include those listed below, as well as all other duties assigned.

Scientific and Technical Expertise:

Has and maintains deep scientific, technical, and clinical expertise in ophthalmology

Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest

Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products

Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders

Key responsibilities:

Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available

Leads the clinical development including planned life cycle management (LCM)

Ongoing assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team

Implements strategies to identify, monitor and resolve clinical program/trial issues.

Serves as the Study Director and Medical Monitor for a study or clinical program as well as reviewing and monitoring study data.

Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders

Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).

Provides clinical input to Statistical Analysis Plans, Target Product Profile and Risk Management Plan

Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators

Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project

Lead the medical/clinical assessment of license-in opportunities, as needed

Manage other CRDs and clinical scientists in the same program, as needed

The CRD is representative for Clinical Development:

at the Global Project Team

in meetings with Regulatory Agencies

in Steering Committees (SC) and Data Monitoring Committees (DMC)

at the Benefit Risk Assessment Committee

at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)

Basic Qualifications:

Medical Doctor (MD) Required, Ophthalmology Specialist

More than 5 years of clinical or scientific experience, or more than 10 years industry experience within the field of ophthalmology and retinal diseases

Fluent in English (verbal and written)

Preferred Qualifications:

Board certified or eligible in Ophthalmology

Completion of a fellowship program in one of the following subspecialties: medical retina/uveitis, vitreoretinal surgery, neuro-ophthalmology

Strong scientific and academic background with deep understanding of retina and eye disease

Clinical research or pharmaceutical experience in ophthalmology

Knowledge of drug development

Good networking ability in cross-cultural environment

Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization

Performance oriented with ability to work along agreed timelines and a focus on strategy and execution

Outstanding communicator. Excellent problem-solving .conflict resolution and decision making skills.

References



Contact this candidate