Nadeem mohammedabdul

Hyderabad, Telangana

adn5t3@r.postjobfree.com

996-***-****

#readytowork

Willing to relocate: Anywhere

Work Experience

Manager Clinical

Aizant Drug Research Solutions - Hyderabad, Telangana October 2018 to Present

trials

Key Result Areas:

• Outsourcing and contracting services provi ying, provided throughout Drug Development; Identifying selecting and managing global external service providers

• Maintaining the relationship with contract research organizations

• Evaluating and analyzing tools and processes to support outsourcing efforts

• Coordinating for contracts investigators for studies and ensures compliance with protocol and overall clinical objectives

ensuring efficient and

• Providing accurate and timely plans and forecasts for clinical trial cost estimates and budgets; ensur compliant contracting of providers

planning

• Validating monthly expense accruals; and providing insightful analyses used to improve future plann

• Collaborating with Legal, Finance and other internal stakeholders on continuous improvement of proce processes and cting

methodology for contracting with all clinical vendors attainment

• Applying strategic sourcing methodology to assure attainment of best service and value and assuring vendor

performance against agreed upon expectations

ensure

• Interfacing with colleagues in R& D to ensure the team is using consistent and efficient business processes and tools for

corporate

outsourcing and vendor management that are compliant with GCP, SOPs, and corporate financial controls ations,

• Managing vendor agreements, supporting the oversight of transferred obligations, and ensure that clinical trial budgets

are based on current operational assumptions

• Communicating with relevant Development Team members, and Functional Leaders ensuring appropriate providers are

identified and managed efficiently

s Development

• Executing tasks as requested by Senior Management to support Drug Development goals and project objectives

established contracts and budget

• Monitoring, controlling, and reporting expenditures against est Administrative Tasks:

ive

• Supervising administrative tasks for Advisory Boards & Institutional Business Meetings

• Coordinating with Medical - as per applicable SOPs and guidance documents

• Managing meeting expenses like honorariums, hotel, travel arrangements As Clinical Trial Associate:

• Worked as Reviewer & Approver of IIP (Investigator Initiation Package)

• Mentored new & existing Document Specialist on SOPs & various applications, organized orientation programs for New

Document Specialist & CRAs and provided trainings on sponsors applications

• Acted as SME for Electronic Library & ReRecords Archive (ELARA). in-house

• Assisted Project Manager/ Clinical Operations Lead and Lead CRA for all in house project activities Study Start-up Phase:

• Assisted COLs in the preparation, timely and accurate review of ICFs for EC submission and approvals

• Created & dispatched prefilling documents to all the sites participating in the trial

• Followed up with Site Coordinator/Principal Investigator to ensure timely compilation of filing package

(IIP)

• Examined IIP documents, prepared site initiation kits & site master files and maintained compliance with ICH-GCP and SOPs to ensure consistence between Trial Master File and Site Master File Ongoing Phase:

• Resolved study related issues and facilitated communication between site personnel & clinical trial vendors including

central labs & monitoring CROs

• Maintained tracking spreadsheets and prepared sites for site audits conducted by Global Teams Manager Clinical

ZenRise Clinical Research Limited - Hyderabad, Telangana November 2017 to September 2018

trials

Highlights:

• Executed and completed site initiation and training activities for site personnel

• Analyzed study budget, generation of accurate TCF for line management approval

• Ensured the preparation of required regulatory submissions & clinical sites IRB submissions and collect of necessary

documents from site at trial startup and throughout conduct the study

• Scheduled and updated the track for site drug supply and other trial related materials

• Monitored and resolved the problems in site activities in line startup of clinical trials, patient recruitment and site

closeout

• Formulated appropriate contingency plans as needed

• Completed and uploaded study monitoring reports in timely manner

• Provided data query resolution at site activities and with Data management

• Resolved site level of update problems in technical systems (EDC)

• Acted as a CRA lead and ensure assigned site visit reports completions

• Adhered to all continual GCP, ICH and internal SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, protocol, drug accountability)

• Facilitated proper communication between site and organization line functions to increase the interest to investigator.

Site Monitoring

• Participated in site selection conduct Feasibility Studies

• Reviewed clinical study protocols & Informed Consent Forms, Case Report Forms and Coordinate EC submissions

• Executed process audits at Study Sites as per SOPs, protocol & regulatory requirements

• Sent follow up letters to sites and submit Visit Reports to the Project Manager as required

• Monitored study deliverables, and contribute to the preparation of consent forms, study guides, monitoring plans, CRFs,

and subject information sheets

• Participated in study planning and set-up activities including vendor management and support, project management,

and coordination of study and implementation plans

• Distributed feasibility questionnaires to investigators being considered for study participation, track and summarize results

• Initiated and tracked confidentiality agreements with sites and initiate and maintain investigator and site contact

information

• Worked with site teams to ensure that necessary corrections are made to expedite the document collection process and tracks status of documents to reflect receipt and approval

• Updated Team Lead of site status and approval status so that drug can be shipped. Partners with site monitor for

scheduling of study initiation visit

• Organized training and maintain good working relationships with the site investigational staff Asst. Manager - Clinical Pharmacology

ClinSync Clinical Research Pvt. Ltd - Hyderabad, Telangana September 2015 to November 2017

Highlights:

• Performed Site Qualification Visit/Pre Site Initiation Visit to identifying the potentiality of a site to match the protocol

requirements for the proper conduct of the trial with quality data in timelines

• Conducted Interim Monitoring Visit of Phase I, II & III clinical trials/clinical studies

• Contributed in Investigational Product management like IP availability and tracking for various sites, timely shipment of IP at controlled temperature

• Coordinated with required Regulatory authority and Ethics Committee dossier preparation and submissions of the clinical trials/clinical studies

• To ensure stepwise management of recruitment target at each site and monitoring the delivery of recruitment targets

against the recruitment plan

• To ensure the preparation and maintenance of Clinical Trial Master File/ Project Master File and Site Master File

• Preparation of Investigator's Brochure, Case Report Form and Subject Diary Cards, under the supervision of Medical

monitor/ Manager

• Assist the medical monitor in writing of Protocol and ICD

• Compiling and writing Clinical Study Report

• Prepare accurate and timely monitoring reports

• Coordination with data management department in handling of queries which may arise during data review process,

validation, verification & analyses

• Preparation of Informed Consent Document, Case Report Form, Subject Diary Cards, as per Trial Protocol

& available

information/data

• Coordination with vendors for various pre-trial activities i.e. translations & back translations of the ICDs, diary cards;

printing of all documents, procuring of CT supplies and ensuring the availability of all at clinical trial sites before the initiation of the study

• Preparation of Prescribing Information/Package Insert (P.I), Patient Information Leaflet (PIL) and Summary of Product

Characteristics (SmPC)

• Involved in literature search for various inputs to the department

• Participate in preparation and review of departmental SOPs

• Handled in-house audits for the clinical studies Senior Research Officer II

Fortis Clinical Research Pvt. Ltd - Delhi, Delhi

November 2013 to September 2015

• To organize induction and periodic training in quality systems (GCP/GLP) to the staff to facilitate study logistics and enhance manpower effectiveness.

• To maintain an up to date knowledge of the regulatory environment and all national and international guidelines for

clinical research and GMP/GCP/GLP.

• To ensure that the QA dept is trained to perform their responsibilities and also ensure refresher trainings.

• To analyze QA data and present compliance trends at the Management Review meeting to seek addressed of deviations.

• To assist Head - Quality Management & training in creating an effective QA system to progressively enhance the quality

of projects conducted at FCRL by close supervision & providing guidance to all QA personnel.

• To plan and conduct internal quality audits as sought by management and provide management with clear visibility on

the level of company's compliance with required quality system during management review meetings.

• To facilitate external audits by sponsors and regulatory bodies on behalf of Head-Quality management

& training. Ensure

timely and appropriate responses are sent towards external audits observations. Ensure that any CAPAs proposed as a

result of external audits are tracked for timely and effective implementation.

• To perform vendor audits at periodic intervals for qualification of vendors to be used for outsourcing certain specific

activities.

• Preparation, review and distribution of Quality Manual & Standard Operating procedures. Identify and ensure that all

quality reference documents are kept up to date.

• To participate in the safety committee meeting and disaster management plan of the organization on behalf of Head-

Quality management & training.

• Maintain the accreditations and certifications of organization.

• Represent QA at operational and cross functional meetings whenever required.

• To monitor the review of IQ/OQ/PQ reports of all computer systems and instruments.

• Review of documents associated with validation of new systems and audit of ongoing maintenance and validation status

of the system.

• To conduct and monitor effectively the conduct of process audits, in-life & retrospective raw data and report audits for

clinical and analytical.

• Ensure quality outcomes and ensure no major/critical errors.

• Ensuring that studies conducted are compliant with SOP, Protocol and applicable regulatory guidelines in real time

manner to avert anyone compliance during process.

• To conduct online checks during study to ensure increased surveillance of study at all times.

• To initiate review and preparation of the standard operating procedures for various processes related activities and other involved processes on periodic basis.

• To prepare the facility for external audits and actively involved infacilition of external audits and inspections.

• To be involved in the review of required clinical/analytical/IT/Instrumentation/general and other departmental

activities related SOPs on regular basis and provide comments on the same.

• Maintain and update master file of the CRO and keep all updated agreements with vendors current.

• Review periodically, the calibration records/certificates, preventive maintenance of the equipment.

• Qualify the external agencies used for all studies conducted by FCRL in order to verify that vendor has adequate

resources in place to execute activities in time and results are in consistent conformance to quality standards, regulatory

and organizational requirements.

• the To plan conduct quality checks as sought by management and provide management with the clear visibility on the level

of company's compliance with required quality systems during management review meetings.

• Verification of journal vouchers with supporting documents.

• Verify of capex requests/approval notes.

• Physical verification of stock items at regular intervals. Senior Research Associate

GVK Biosciences Pvt. Ltd - Hyderabad, Telangana

January 2008 to November 2013

To prepare monthly outputs of the team of projects completed and initiated to help tracking the cost of materials and ata

supplies and provide the data to account section.

• To monitor and guide the activities of reports group of the section.

• To plan the project activities.

• To define and monitor role and responsibilities of analysts for routine work, SOP, protocol and regulatory related

compliance.

Associate-III

Aurobindo Pharmaceutical Ltd

September 2004 to January 2008

Research Associate

• Initiate the requisition for Forms as per SOPs.

• GCP, Fallow the GCP.

All logbooks and all forms documentation done as per SOPs and G

• Reviewed validation and study reports; prepared SOP's for instruments and methods while accomplish the groundwork

for audit preparation.

Education

B. Pharma.

SSR College of Pharmac - Osmania University

2005

Skills / IT Skills

• Site selection, site qualifications, monitoring and study start-up and study close out

• Microsoft Word

• Outlook

• Management

• Healthcare

• Scheduling

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