Clinical Research Trial

Ravikanth Chava

*********@*****.***

202-***-****(M)

SUMMARY:

I have over 10 years of experience in Clinical research and over 8 years in Trial Management. Solid experience in Clinical Studies in support of Data Management for EDC, IWRS, IB, Medidata Rave, Inform, J-Review, Oracle Clinical, ClinTrack, ClinPay, IMPACT and CRF/TMF till CSR. As a Global Clinical Trial Manager at Novartis and in same capacity at Allergan prior, including experience earlier as a Lead CRA/CTM and Study Coordinator. Worked in several therapeutic areas like I&I, COPD, GIT (IBS, CD, and UC), Oncology, and Cardiovascular in faze I to III to mention a few which totally align with studies like IPF, CF, OA, CD and UC of Galapagos.

KEY SKILLS:

Extensive expertise on clinical trial management with clinical research background, built on multiple direct and transferable skills and knowledge in areas:

CTMS: ClinPay, Relay, ClinAdmin, IMPACT, ClinTrack, Veeva

SOP Implementations

ICH Guidelines/GCP Expertise

Phase I, II, III Studies

EDC: Inform, Medidata Rave, J-Review

E-TMF: FirstDoc, Veeva Vault, CREDI, CTP

Vendors used: Central Labs, MAPI, Quorum, ERT, Cardio core, Tekro (App), Cognizant, CRF (ePRO)

CROs: Parexel, Covance, PPD, Inventive, ICON

Study Designs

Protocol/Study Procedures Manuals

FDA Audit Issues

Monitoring Reports/Clinical Study Forms

Source Documentation Verification-EMR

Investigator Brochures

Technologies: MS Word, Project, Excel, Power Point, Outlook

THERAPEUTIC AREAS of EXPERIENCE:

ONCOLOGY: Phases I, II & III

worked on Vendors (Almac/Covance/Baroclinic) of Multiple Myeloma Phase 2 and 3.

Conducted CTT and vendor meetings biweekly as per GCP-ICH guidelines.

Tracked the IP shipment and updated the Who’s Who’s contact list.

Lead various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as SOPs and policies.

Screened/Randomized/Coordinated patient eligibility for RET gene Fusion Program which includes MEN-1&2 (R001 & 002) and Osteosarcoma Protocol in children

Worked on RECIST criteria and evaluated the outcomes including identification, selection and reassessment of target/non-target lesions

Identified and worked on measuring the CT scan lesions Metastasing >12mm in diameter

Worked on Imatinib Mesylate in CML treatment options plus worked on Leukemia’s (B-cell) especially at targeting the DNA mismatch repair to decrease the defective gene cell cycle from S to M phase

Worked on gene transcription to hit the promoter gene to get a break in Leukemia

Consented/Enrolled/Interviewed eligible patients on Docataxel vs Genetespib in Advanced NSCLC-III stage lung cancers

Conducted on-site monitoring visits in accordance with applicable local regulations, Good Clinical Practices, ICH Guidelines, and Standard Operating Procedures

Assisted in the development of project team members through training/mentoring

Developed project specific tools, documents, training materials for project team and sites and updated as necessary throughout the course of the study

Worked with Vendors (Covance, CRF, Bioclinica and Almac) and QC-ed the contracts and validated Investigational Medicine Product (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process.

COPD: Phase III & IV

Worked on double blind, randomized, placebo-controlled, parallel-group study to evaluate the effect of Roflumilast on exacerbation rate in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with a fixed dose combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS) in Allergan for two years.

Develop and deliver high quality data in collaboration with other functions (e.g. Medical Operations, Monitoring, Data Management team and Biostatistics team), and CRO (Parexell, Covance) for outsourced trials for a year in Novartis working on QAW 2316/2317 for Br Asthma.

CARDIOLOGY: Phases II & III (24 months)

Regional Travel 2 Protocols 8 sites.

Multicenter, randomized, double-blind, 8-week study to evaluate the dose response, efficacy and safety of an investigational drug resins in phase III pediatric hypertensive participants between 6-17 years of age

A twelve-week, phase II randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the efficacy, safety and tolerability of a Fraxeparin investigational drug compared to an existing therapy in people with chronic heart failure and preserved left-ventricular ejection.

Physician’s Specialty Study: compared mortality rates among 8241 patients hospitalized for acute MI.

Continuing Evolution of Therapy Study: large-scale treatment comparison of angioplasty, CABG, and medical therapy in patients with CAD that coincided with a dramatic rise in PTCA.

INFECTIOUS DISEASE: HIV: Phases I, II & III (24 months)

Regional Travel 2 Protocols 8 sites.

A Phase I Study of Autologous T-Cells genetically modified by Zinc Finger Nucleases SB-728 for Reduced CCR5 Expression in HIV-Infected Patients with Detectable Plasma HIV RNA who have developed resistance to Highly Active Anti-Retroviral Therapy (HAART).

A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX in HIV-1-infected adults on Potent Combination ART with Conserved Immune Function: A5247.

Worked on AZD5847 TB drug in a Phase 2a trial to assess the effectiveness of the drug for patients with TB, including patients with HIV and TB.

A Phase III Comparative Study of (Nevirapine and Delaviridine) Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers: A5257.

PROFESSIONAL EXPERIENCE:

Regeneron Pharmaceuticals, NY 09/2019-Present

Sr. Clinical Trail Manager

Lead the start-up, maintenance and close out phase of the study (Myasthenia Gravis-Phase 3) until the publication of the study results.

Selected sites based on CRA Input, WCG Survey and usability list so that sites can provide max subjects.

Made site accountable as promised by site in terms of projected enrollment numbers so that we are reaching the quarterly goals.

Lead the site selection process meetings along with functional leads to make sure CRO is accountable for the timely PSVs leading to timely site activation

Managed clinical study through delegation of responsibilities to a cross-functional study team, working under my guidance and reporting it to my associate director to ensure clean, high-quality data is delivered within the specified time and cost.

Ensured site monitoring reports are accurate and thorough <60days, reviewed on a regular basis (Onsite/Remote).

Oversee the cross functional study team to ensure timely site start-up, maintenance and close out minimizing the stumbling blocks for timely results.

Worked on submissions to regulatory authorities (Brazil, Serbia and India) in regards to Post Trail Access (PTA).

Reviewed Global ICFs as per protocol amendments so that they are implemented at country level and followed-up with CRO for site level implementation.

Reconciled e-COA data (Questionnaires/Scales) against EDC for discrepancies from time to time so that quality data is included in the snap shot.

Reconciled the enrollment numbers in IRT Vs EDC Vs ODR to get the exact numbers to the director to make a better judgement.

Confirmed that the IP (Parexel) is delivered on time to the site to cut the delay of site activation and followed up with Logistics so that IP is returned on time maintaining the accountability logs.

Ensured a strong understanding of methodologies and approaches, in alignment of clinical project goals with Clinical Operations program objectives.

Oversee the Site selection, management and oversight of study vendors (CRO-PPD, Parexel, Viracore) to ensure that Regeneron’s clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial deliverables and performance goals are met.

Saved $ 440,000 grant by weeding out duplicates invoices before approving them.

Pulled up the Site Leads for unfinished Trainings in Trifecta/Investigator space (SIV training)

Escalated the mismatched CTAs in budget meetings and the amendments.

Ensured accurate and comprehensive completion of documents needed for Health Authority (IRB) submissions by working with Regulatory Affairs to establish timeframes for submissions

Enforced end dates to make sure TMF assigned is maintained clean right from startup maintenance and close out and a quarterly metrics is pulled for the FDA Inspection readiness.

Oversee the management of certain aspects of project management to junior staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.

Mentoring team members for a clean timely Database lock-Medidata Rave (open/resolved queries) to mention a few apart from quarterly check-ins and performance appraisals for direct reports with constructive feedback.

Adjudicating PDs and FU with site CTLs/CRAs so that queries are entered and answered before data cut off for the IA and IDMC snap shot.

Sanofi, Bridgewater, NJ July 2018 – July 2019

Clinical Trial Operations Manager

Provide oversight on study activities to ensure progress according to study timelines

Support the Senior Lead CTOM and/or Lead CTOM in taking study logistic decisions and implementing operational plan(s) upon endorsement by the study team

Ensure proper documentation availability to the sites, vendors and sponsors.

Ensure proper collection and validation of data (Cognizant) and documentation on a timely manner

Organize and lead study meetings with Vendors like Almac (IVRS), Covance (Labs), ePRO (CRF) for scales, diaries, questionnaire’s, Bioclinica (ECG/X-Ray/Radiology) and Teckro for app.

Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Product (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process.

Participate in selection and management of vendors, development/follow-up of the associated budget

Preparation and oversight of study audits/inspections both internal and external

Provide oversight and preparation for FDA pre-approval inspections (PAI)

Participate in the training of new CTOMs on therapeutic area and general responsibilities within their function

Novartis, E. Hanover, NJ April 2017 – June 2018

Global Clinical Trial Manager

Supported Sr. GTL in ensuring all operational trial deliverables are met according to timelines, budget, procedures and quality standards

Responsible for the development of study tools, guidelines and training materials (SOPs), management of clinical study material, implementation of issue resolution plan as per GCP-ICH guidelines

Developed, organized and monitored the collection, processing, storage and logistics of biomarkers (Nicotine, Cotine, NNT, and BAP), immunogenicity and pharmacokinetic samples within Phase I to III of clinical study, apart from other studies.

Develop and deliver high quality data in collaboration with other functions (e.g. Medical Operations, Monitoring, Data Management team and Biostatistics team), and CRO (Parexell, Covance) for outsourced trials

Provide oversight of the clinical operation components that relate to study reports and documents for regulatory submissions (IRB approvals of Protocol/Amendments/ICFs/SAEs, and Closure)

Track project progress at assigned sites (subject status, safety/adverse events, CRF completion, payments, regulatory documents) and utilize Internal tracking tools such as Pulse and IRT for drug supply and study management

Oversaw the study related documents like Investigators brochure, laboratory manual, sample handling sheets as well as tracking of shipment schedules, sampling and storage requirements in close collaboration with premier and analytical laboratories

Played a lead role in CTT meetings and in selection of vendor identification/qualification/ systems set-up/management including EDC, IWRS, Central Labs, specialty services (ePRO, eDiary, etc.)

Responsible for the management of the trial master file (CREDI)/ClinAdmin under the guidance of the GTL

Work cross functionally with other clinical staff and/or an external CRO (Paraxell, ERT, MAPI, Quorum), monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)

Responsible for handling of IP samples according to protocol, SOPs, GCP and ICH-guidelines

Adhere to key performance indicators for clinical study development, conduct, and reporting (SAEs) and resolve routine site inquiries

Oversee site investigational product requirements and accountability and other supply requirements according to the protocol

Responsible for the coordination of activities (PI, Sub PI, SC and monitors) leading to site initiations (IP shipment from depo and reconciling after use)

Support in trial close out activities including end of trial checklist, operational support of the CSR appendices and trial registries, etc.)

Participate in the on-boarding, mentoring and training of CRAs/CTAs

Allergan (Actavis) Jersey City, NJ November 2015 – March 2017

Global Clinical Trial Manager

Responsible for supporting the development and management of various aspects of the integrated study operational plan (start up, conduct, close-out, and vendor/Budget oversight) with input from key stakeholders inclusive of all operational until the CSR

Supervised all start up activities (LIN-62 Pediatric study of IBS) e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight

Approved site and vendor invoices in LIN-10 Pediatric study of IBS as per executed site/vendor contracts and reconciled the lost checks which are lost in transit.

Monitored trial progress and ensured GCP ICH compliance to identify, evaluate and rectify problems.

Responsible for Overseeing the vendor management activities like preparing the RFPs, bid defense meetings and executing MSLs with CROs and external vendors

Comfortable in using InForm Platform (EDC), Clinical Trail Media (recruitment), Tangerine (IM), MAPI for questionnaires

Reviewed all Pediatric Assent forms which are archived in E-TMF (IBS studies of LIN-10 &62)

Identified and selected clinical investigators and contract research organizations (CROs) appropriately for the therapeutic area and study phase

Assessed potential study sites and CROs (PPD, ERT, Covance) to ensure that facility, staff, and likely subject populations met Pediatric study needs

Developed and managed budget, timelines and quality of the study and its deliverables

Responsible for foreseeing and tracking of study costs and ensuring that IT-systems were up to date with current and accurate information (e.g. IMPACT/DDO/Clear Trial/Relay)

Responsible for training and oversight of CROs to ensure compliance with timelines and budget

Escalated severe deviations (SD) in Pediatric studies of IBS (LIN-10 &LIN-62) to a key parameter (i.e. recruitment, timelines, patient safety, protocol compliance, data collection/cleaning, budget) after discussion and in alignment with the Study Team to OPL/CPL and functional manager

Worked directly with the Clinical Development Manager (CDM) to facilitate cross functional team and vendor communication for study-wide problem-solving regarding study progress and trial issues

Assured the management of all governance committees involved in the study conduct, i.e. PRC, submission/approval by competent HA and IRBs. (for the Pediatric studies, the Sr. Study Manager was the main contact partner for all external service providers involved in the study conduct and needs to ensure adequate oversight)

Assured maintenance and Quality Control of study Trial Master File (TMF-FirstDoc) was up to date for inspection readiness in Pediatric studies of IBS (LIN-10 &LIN-62)

Established and maintained project working files, tracked critical documents (1572/ML/CVs, PSPs etc) and reported discrepancies accordingly

INC Research, LLC - Old Lyme, CT April 2014 - November 2015

Lead CRA/CTM

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)

Conducted PSVs, SIVs, IMVs, and COVs required as per GCP-ICH guidelines

Managed contract, budget and financial reconciliation process

Reviewed Form 483 of Oncology drug Ematinib Mesylate along with Lead

Worked with CROs (Cenduit, IRT and Q2)

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

Updated the trail data in IMPACT, ClinTrack software of CTMS in Phase II-III studies to cut down the time loss on label creation

Used Medidata Rave, Clinphone and Oracle

Completed accurate study status report and maintained study documentation

Ensured adverse events and serious adverse events were being properly recorded and reported

Genentech, SF October 2011 – March 2014

Clinical Study Coordinator

Received and responded to medical inquiries from patients, customers and medical professionals

Completed accurate and timely data collection, documentation, entry, and reporting.

Scheduled monitoring and auditing activities.

Reported to the FDA all literature and foreign Adverse Drug Events reports

Reported Periodic Adverse Drug Experience Reports (PADER) to the FDA

Wrote Standard Operating Procedures (SOP) open and close deviations

Reviewed study protocols, study designs and CRF templates of Docataxel (Oncology drug) for IRB Submission

Participated in NDA/IND submission of oncology drug Docataxel with FDA for approval

Reconciled TMF missing documents for the Oncology study drug Docataxel from sites

Helped with internal and external audits that pertained to study budget allocation

Used Aris g and Argus databases to track adverse drug event reports

Bayer Healthcare, NJ Apr, 2009 – September 2011

Clinical Monitor/Supervisor

Assisted Department Head in the management of operations and the team

Acted as Deputy Responsible Person of Pharmacovigilance

Used Pharmacodiagnostic test (Bone marrow aspiration and Biopsy, Echocardiography, CT scan, MRI) for early identification in ALL and CML.

Worked on Biomarkers (CD-13, CD-33 for myeloid leukemia’s and HLA-DR for AML, TdT for ALL) for early identification and staging.

Took lead in source document verification from time to time to meet the deadlines.

Management of Pharmacovigilance Agreements including authoring & executing SDEAs, negotiations with licensing partners, performed reconciliation, ensured compliance and resolved conflicts

Performed triage and medical review of adverse event, medical inquiry and product quality complaint reports.

Responded to medical inquiries

Managed data entry team for adverse event reports

Assisted in drafting and revising SOP's

Reviewed Business Agreements and Quality Agreements

Performed retrospective review of adverse event reports from the SDB

Efficient in MedDRA

Life Hospitals, Hyd, India Sep 2000- Aug 2007

Clinical Monitor

Assisted General Practitioner in diagnosing patient in outpatient clinic.

Reviewed patient case sheets and ordered required X rays/labs/ECG/Sonograms to rule out differential diagnosis to treat the patients.

Took rounds of the ward including ICU along with consultants to diagnose and treat patients.

Worked closely with visiting physicians in sorting out the source documents.

EDUCATION and CERTIFICATIONS

Masters in Health Services Administration (Sept 2007 - March 2009) Strayer University, Takoma Park, Washington, DC, USA.

Bachelor of Science from Osmania University, AP, India.

GCP Certification from NIDA – April, 2019

FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond.

Professional CRA Certificate from PHRAM-XM in 2010.

PROFESSIONAL AFFILIATIONS:

Certificate in A.C.L.S (ADVANCED CARDIAC LIFE SUPPORT SYSTEM) by Axon Anesthesia Associates Put. (2005)

HIPAA Trained and Compliant

References:

Will be provided upon request.

CLINICAL STUDIES

Therapeutic Area

Therapeutic Area Detail

Sub-type

(e.g., Diabetes Type 1 or Type 2?)

Phase

Role

(e.g., monitor, in-house, etc?)

# of

Sites

Aspect of study:

1. Start-up

2.Interim

3. Close out

4. Data lock

Length on Project

Cardiology/HIV

Fraxeparin/

NNRTI

Blood thinners

Phase I-III

Regional CRA

2 years

1,2,3

2 years

Oncology

Genetespib vs Docataxel

NSCLC

Phase I-III

Regional CRA

4

1,2,2

4 years

Oncology

Ematinib Mesylate

Leukemia

Phase I, II, III, IV

Sr.CRA/CTM

4

1,2,3

2 years

Pulmonology

Roflumilast

COPD

Phase III, IV

CTM

355 (US) & 372(ROW)

1,2,3

13

Months

GIT

LIN-MD-40(Linaclotide)

Laxative

Phase II, III, IV

CTM

35 out of 80 sites

1,2,3

6 Months

GIT(Pediatric)

LIN-MD-62& (Linaclotide)

Functional Constipation

Phase I, II&III

CTM

80 Sites

1,2

7 Months

GIT

LIN-MD-63& (Linaclotide)

Functional Constipation

Phase I, II&III

CTM

100 Sites

1,2,3

7 Months

GIT(Pediatric)

LIN-MD-10(Linaclotide)

Constipation/Chr.Idiopatheic Constipation

Phase II, III, IV

CTM

83Sites

1.2.3

6 months

Pulmonology

QAW2316

Br Asthma

Phase III

GTL

60 (US)

110(ROW)

1

1 year

Pulmonology

QAW2317

Br Asthma

Phase III

GTL

80 (US)

130(ROW)

1

1 year

Oncology

SAR650984 (Isatuximab)

Multiple Myeloma

Phase III

CTM

150 Sites

300 (Subjects)

3,4

Ongoing

Oncology

SAR650984-TED10893

CD38+ Hematological Malignancies

Phase II

CTM

Phase 1: Approximately 12 sites

Phase 2: Approximately 80 sites

3,4

Ongoing

Infectious

REGN10933-10987(Casirivimab &Imdevimab)

COVID

Phase II, III

CTM

80 (US)

140(ROW)

1,2,3,4

Closed

Infectious

REGN10933-10987(Casimira &Imdevimab)

COVID

Phase II, III

CTM

80 (US)

140(ROW)

1,2,3,4

Closed

I&I(Rare Disease)

R3918-MG-2018

MG (Myasthenia Gravis)

Phase 3

CTM

140(ROW)

1,2,3

Start-up

Hematological Cancers

R7508-CAT-2392(Factor IX)

Prophylactic of cancer associated treatment in solid tumors

Phase 3

CTM

120 sites 300 subjects

3

Start-up

Hematological Cancers

R7508-CAT-2396

Treatment and secondary prevention of symptomatic VTE

Phase 3

CTM

120 sites 300 subjects

3

Start-up

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