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Manager Clinical Research

Location:
Hyderabad, Telangana, India
Salary:
30percent
Posted:
January 13, 2020

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Resume:

Core Competencies

Clinical Research& Trials

Administrative Support

Reporting & Documentation

Budgeting & Forecasting

Training & Development

Data Validation

Project Management

Cross-functional Coordination

Leadership & Team Management

Executive Profile

Qualified Clinical Research Associate offering my 15+ years of experience in Clinical Research& Operations with expertise in Clinical trials, Pharmacokinetic and Statistical Analysis, Good clinical Practices (GCP), Good Laboratory Practices, Clinical Research Protocols, local and international regulatory requirements (conforming to USFDA, EMA, HPFB, TGA, ANVISA, CDSCO, and others).

Currently associated with Aizant Drug Research Solutions - Hyderabad as Clinical Manager; providing assistance to project teams& study managers for ongoing studies, administering clinical trials, maintaining proper documentation and ensuring compliance with company SOPs & guidelines.

Expertise in all aspects of the clinical trial start-up including, identification, evaluation and management of CROs and vendors. Developed and manage the budget, timeline, monitoring schedule and all monitoring activities.

Excellence in site selection, qualification, monitoring and ongoing site/investigator support. Wrote and maintained Monitoring, Data Management and Communication Plans.

Therapeutically knowledge in Infectious Disease (Travelers’Diarrhea), Oncology (Metastatic Breast Cancer - Phase II & III), Endocrinology (Diabetic Type I & II), Ophthalmology (Uveitis and Conjunctivitis) and Cardiovascular.

Monitored & ensured that the project progressed according to quality standards & SOPs to fulfill local regulations and was completed within budget, as per schedule and according to contract specifications.

Effective in conducting trainings for New Document Specialist and CRAs on sponsor applications.Detail-oriented professional with attention to details, accuracy, and teamwork.

Career Timeline

Organizational Experience

Oct’18 – Present: Aizant Drug Research Solutions - Hyderabad as Manager Clinical trials

Key Result Areas:

Outsourcing and contracting services 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

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

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

Collaborating with Legal, Finance and other internal stakeholders on continuous improvement of processes and methodology for contracting with all clinical vendors

Applying strategic sourcing methodology to assure attainment of best service and value and assuring vendor performance against agreed upon expectations

Interfacing with colleagues in R& D to ensure the team is using consistent and efficient business processes and tools for outsourcing and vendor management that are compliant with GCP, SOPs, and corporate financial controls

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

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

Monitoring, controlling, and reporting expenditures against established contracts and budget

Administrative Tasks:

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 & Records Archive (ELARA).

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

Nov’17 - Sep’18: ZenRise Clinical Research Limited, Hyderabad as Manager Clinical 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

Sep’15 – Nov’17: ClinSync Clinical Research Pvt. Ltd. – Hyderabad as Asst. Manager – Clinical Pharmacology

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

Nov’13 – Sep’15: Fortis Clinical Research Pvt. Ltd. – Delhi as Senior Research Officer II

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.

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.

Jan’08 – Nov’13: Senior Research Associate GVK Biosciences Pvt. Ltd. – Hyderabad

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

Sep’04 – Jan’08: Research Associate-III Aurobindo Pharmaceutical Ltd.

Initiate the requisition for Forms as per SOPs.

All logbooks and all forms documentation done as per SOPs and GCP, Fallow the GCP.

Reviewed validation and study reports; prepared SOP’s for instruments and methods while accomplish the groundwork for audit preparation.

IT Skills

MS Office Programs

CTMS

Inform

Openclinica

Medidata

Rave

IWRS

Clinphone

Vivavault

SAS-9.4

Winolin-8.0

Abby

Analyst Software

Mass Lynx

Publications & Presentations:

Given a presentation on “Application of Computers in the Field of Pharmacy” in the conference of 55th Indian Pharmaceutical Congress held at Chennai

Certification& Trainings

Certificate from WATERS GLOBAL SERVICES on Liquid Chromatography Mass Spectrometry

Certificate from SIX SIGMA BIOSOLUTIONS PVT. LTD. on International conference on Harmonization- Good Clinical Practice

Attended 53rd Indian pharmaceutical congress, Delhi

Attended 55th Indian pharmaceutical congress, Chennai

Attended 57th Indian Pharmaceutical congress, Hyderabad

Participated in the organization of recipe-2006(A National Pharmacy Meet)

Education

B. Pharma. from SSR College of Pharmacy – Osmania University in 2005.

Personal Details

Date of Birth: 20th July 1982 Languages Known: English Passport Details: No. R6891902, valid till 2028

Address: H.No. 3-3-47/1, Baghameer Colony, Near Hanuman Temple, Kukatpally, Hyderabad, Telangana, India 500072

Phone No:+91-996*******, Email address: adbafu@r.postjobfree.com.

M.A.Nadeem

Senior Professional

CLINICAL RESEARCH & TRIALS

Phone: +91-996******* E-mail: adbafu@r.postjobfree.com

Fortis Clinical Research Pvt. Ltd. – Delhi as Senior Research Officer II

Sep’15 – Nov’17

Nov’17-Sep’18

Since Oct’18

ZenRise Clinical Research Limited, Hyderabad as Manager Clinical trials

Aizant Drug Research Solutions - Hyderabad as Manager Clinical trials

Nov’13- Sep’15

ClinSync Clinical Research Pvt. Ltd. – Hyderabad as Asst. Manager – Clinical Pharmacology



Contact this candidate