Clinical Application Research Associate

Raju Yarra

MBBS, RPSGT, RST

Contact: 248-***-**** E-Mail: *******@*****.***

Ann Arbor, Michigan

Clinical Research Associate/Manager

Professional Experience

Vapotherm Inc

Since Sept 2020 – July 2022

Sr. Clinical Application Manager& Clinical Research Associate, Exter, NH

Conducted reviews of documentation needed for internal and regulatory (e.g., FDA/CA audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Alio’s internal SOPs, and US and OUS regulations

Coordinated all phases of a clinical study from study development to execution of final results, analysis and interpretation with minimal oversights.

Worked on Interfaces with key functional areas in order to align the clinical study with needs for other business areas (Marketing, research, regulatory, development, patient management, reimbursement.)

Developed therapeutic and device operation knowledge and applies this knowledge to clinical study processes

Involved in proactive updates regarding the status and progress of the study to the study team and senior management

Responsible for clinical operations of products in NICU,PICU and ICUs .

Monitored three Phase I- III global clinical trial sites. Ensured clinical study was conducted per established policies, standard operation procedures (SOPs), regulations, and Good Clinical Practice (GCP).

Managed contract, budget and financial reconciliation process.

Prepared and submitted document for Investigational Review Board (IRB) approval.

Advised and trained site personnel on protocol and regulatory requirement.

New product introduction and clinical validations performed.

Quarterly reviews with manager and forecasting updates from channel partners and sub dealers

Reviewed on-site file and record, informed consents, clinical report form (CRF), source document, and drug accountability for completeness, accuracy, consistency, and compliance.

Clinical discussions with clinicians on therapy and aligning validations across the centers

Exploring the opportunities of sales, trials, and demonstrations in public and private hospitals.

University of Michigan, Ann Arbor

&

Advanced Center for Sleep Disorders since Feb; 2017 – Aug 2020

Sleep Tech- Sleep centers, Ann Arbor & Georgia

Dedicated, passionate, and compassionate clinical individual with demonstrated and unyielding practice in performing polysomnography and obstructive sleep disorders, respiratory therapy, and neuro diagnostics. Utilize comprehensive knowledge of the concepts, practices, procedures, and techniques related to EEG, respiratory therapy, and polysomnography equipment. Exhibit extensive familiarity of sleep disorders and the use of polysomnographic methods for its diagnosis and treatment. Apply familiarity of current respiratory care practices as well as effective and safe approaches in administering pulmonary therapies and interventions. Display proven exceptional verbal and written communication skills; able to cultivate and maintain rapport with large groups of individuals.

Core Competencies

All Polysomnography Diagnostic procedures/ Titration protocols

Case Management/ research protocol studies

Reporting and scoring Intervention

Equipment Maintenance

Patient Relations Management

Ability to perform comprehensive training to new technologist on adult, pediatric, and neonatal sleep disorder testing. Clinical application and titration of CPAP, Bi-level, Bi-level ST, AVAPS, Auto SV, Trilogy 100 and transcutaneous end tidal CO2 in providing diagnostic services(NPSG,PAP Titrations, MSLTs,MWTs, RBDs and Seizure montage studies) to adult, pediatric and neonatal patients.

Attend and complete neuro and respiratory diagnostics cross-training.

Spearhead strategic efforts in preparing, analyzing, and scoring sleep studies for physician interpretation.

Play a pivotal part in the progression for sleep center accreditation.

Designating research protocol, implementation of existing policies on multi site studies, drug interactions on sleep disorders and narcolepsy.

Clinical trainings and product updates on sleep diagnostics, therapeutics and Non Invasive Ventilation.

Updating Insurance claims, PAs, Billings and clinical notes with overseas team.

Coordinating with offshore billing management with medical biller’s team.

Sleep center Operations, trouble shoots and various researches reporting support.

Coordinating with providers, Insurance, Medicare & other DMEs for smooth operations.

Partially handle customer service issues, inventory control and ordering, merchandising, procure authorizations through managed care plans, Medicare, Medicaid, Labor and Industries, TriCare, and commercial plans along with team.

PHILIPS LTD since Oct; 2013 – Jan 2017

Clinical Marketing Manager – (Sleep &Respiratory care)

Key Result Areas:

Heading clinical marketing & Application team of diagnostics, therapeutics of 4 nations.

Recognized for superior performance as “best employee” of Philips India honoree.

Collaborated with Marketing & Global product team and resolve Asia specific customer issues, leading to substantial improvement in customer satisfaction and growth year on Year.

Working with sales team to achieve sales volumes and profit goals as per AOP for all modalities (Respiratory, Monitoring &NIV diagnostics & Therapeutic devices).

Incredible year on year sales growth sales growth in diagnostics & rapid growth in diagnostics in consecutive years across the country (2013 – 2017).

Strong Presentation skills, clinical & business acumen in diagnostic & therapeutic products.

Supporting global product managers in the launch/introduction of new solutions and enhancements developed by the BIU to the local market. (Upstream & downstream marketing activities).

Build sales capability in the team to do clinical selling and up sell of products

Developing business cases for new products and services for consideration in the portfolio management process.

Maintains up to date records of sales activities by distributors and actively works to help dealers increase sale of company products to meet defined objectives.

Obtain global customer requirements and product specifications via market research activities, market analysis, and on-going communication with global marketing and sales.

Collaborated with key Academies for Trainings, Events and National &International- Asia pacific programs.

Offer on-site service, training, and education to customer’s bio-medical technicians.

Field Marketing to enable the market sales teams &working on price quotes, shipping, resolving order problems, etc

Developed, managed and leveraged clinical relationships support broad business goals (e.g. poster development, white papers, presentations, clinical evidence, market and clinical evaluations). Identify and develop speakers to participate in programs, symposia, and peer-to-peer clinical plans.

Ability to synthesize market and customer feedback and existing and new products into solutions; comfortable with making tradeoffs, decisively.

Heading – Philips Diagnostic Center in India – Clinical support to KOLs

Managed KOLS of 4 nations (India, Srilanka, Bangladesh and Nepal) on clinical updates and symposiums.

Clinical marketing through newsletters and eclinicals on global research.

70% travelling across the nations to support sales team and achieve AOP and quarterly targets.

Key contribution in Research & Development of “Super Value PAP” at PHILIPS INNOVATIVE CAMPUS

PHILIPS LTD since Oct; 2010 – Sept 2013

Clinical Application Manager – Sleep Diagnostic & Respiratory Therapy Portfolio (Home Health care)

In-depth knowledge in products & application of all Homecare devices and diagnostic clinical application.

Field Application support to Medical institutes, KOL centers and regional centers.

Deep knowledge in products & application of all S&RC, NIV & Invasive ventilators for pediatrics & adults.

Offering on-site service, training, and education to customers, techs, physicians& bio-medical technicians.

Acute care setup, Hospital to home setup unit, protocol design and implementation.

Responsible for reporting customer feedback according to applicable quality Standard policy and follow up relevant assigned quality & regulatory training in a timely manner.

Deployed Product trainings and Marketing activities for all Channel Partners.

Nurtured team of 6 application specialists as certified persons.

Supported sales team for clinical selling, trainings and product positioning.

Knowledge on competitor’s products like, EPR, IVAPS & algorhythms.

Interacted with development, functional and operation teams on all aspects of Autosys run book activities and attended project level meetings.

Previous Experience

1.Yashoda Super specialty Hospital & Gandhi Medial college, (Apl’09-10 Sept,)

Clinician –Acute Care

Highlights:

Handling Indoor & outdoor acute patient cases.

Experience in Acute Emergency & Chronic cases with Pharmacological management on adults & Pediatrics.

Handling diagnostic procedures in medical management and follow up with treatment procedures.

Acted as an in-house consultant for all emergency situations encountered in the hospital.

Interaction with patient attendants to brief them about current status and any other specific problems.

To check the dosage, frequency, route of administration of all medications, considering precautions.

Pre & Post-surgical management.

Practical knowledge on Hospital & Home care Ventilators.

Documentation of all case studies for HiPAA Act & Institutional policies as standard procedure.

Academic Details

MBBS, MD (General Medicine) from Ukraine, 2000 – 2008,

BHMS from NUHS in 1996-2000

Intermediate (+2), Board of Intermediate, AP, 94- 96

SSC, Board of secondary school, AP, 1994

Medical Technical Skills

RPSGT, from BRPT, USA – 2007, 2012 & 2017

RST from ABSM, USA – 2012

CPR - Redcross

Academic Conference Presentations & articles:

1) “Updates in Respiratory Medicine -2016”- Presented as Speaker at Chettinad Academy of Research & Education.

2)Conducted “Workshop on diagnostics” at Annual Conference of Association of Chest Physicians of Gujarat (ACPGCON-2015)

3) “Sleep Disorder Epidemic” topic presented at DY Patil Medical college, Pune, September 2016.

4) “Sleep Apnea- A WORLD EPIDAMIC” A topic presented to Indian Medical Association, Bareilly, 2013.

5) “Non- Invasive ventilation in SDB” topic Presented at Annual conference of Indian Medical Association, 2015.

6) “Polysomnography hookup &10/20 system” topic presented at Annual conference of All India Institute of Medical Sciences, Delhi 2015.

7) “Auto Servo Ventilation in CSR” topic presented at 3rd SLEEP conference, Jaipur golden Hospital, New Delhi, 2012.

8)“Sleep Epidemiology” topic presented at Srilanka Chest Physicians forum, Colombo 2015.

9)“Narcolepsy & MSLT interpretations” topic presented at Indo American Cancer Institute, Hyderabad 2014.

10)“Sleep apnea, COPD and PCOD disorder in women” topic presented in Gynecological association of India, Forum had panel discussion on diagnosis and management of it in pregnant women with in lab sleep studies, 2015

11)“Cardiac co morbidities in sleep apnea” 2 days lecture on holter screening and changes of cardiac deviations presented in CARE Institute of Cardiology, Bhubaneswar, Orissa 2016.

12)“Sleep Apnea – An epidemic, causing loss to nation” A social lecture presented to All India Physicians Associations, Delhi 2013.

13)“Reconstruction of upper air way in Sleep Apnics” A session shared with ENT surgeons on Annual ENT conference in Bangalore 2013. Panel discussion on surgical benefits vs Positive Airway Therapy in pediatric cases.

14)“ TV Show on Sleep Apnea in Life style disease” In TV9 Television in regional language for 30 mins and question & Answers for viewers on sleep apnea disorder.

15)“Sleep Apnea & Polysomnography” topic presented as faculty in World Congress of Chronomedicne, at Lucknow, 2016.

News Paper articles:

16)“Kyu nahi sote hum” an article published in regional language in Jagaran news paper in 2015.

17)“Drowsy drivers’ poses high risk of mishaps” an article published in Times of India news paper in Jan 2014

18)Published “Sleepless City” article in IndiaToday.

Personal details:

Date of Birth: 10/17

Languages Known: English

Present Address: Ann Arbor, MI

Contact Number: +1-248-***-****

Sponsorship: Not required (Green card)

DECLARATION

I hereby sincerely declare that the facts mentioned above are true to the best of my knowledge and hold complete responsibility in support of the same.

Name of the aspirant.

(Raju Yarra)

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