PRADEEP THAKER

** ******** ***** • Howell NJ **731 • H-732-***-**** • C-732-***-****

abl4p1@r.postjobfree.com

CAREER OBJECTIVE

To provide the expertise dedication and imagination to propel the company towards a prosperous

future and with daring spirits and inquisitive mind seeking a broad range of opportunities for personal

and professional growth & efforts being realized in improved health worldwide as Clinical Research

Professional.

EDUCATIONAL QUALIFICATIONS

Bachelor of Science, Biology - Bombay University, Maharashtra, India

Computer Proficiency

Microsoft Office – word – Excel – Power Point

SUMMARY OF EXPERIENCE

• Over four years of Clinical Research Experience in all Phases of clinical trials.

• Expertise in clinical monitoring skills that include conduction of qualification, initiation,

monitoring and close out visits of the sites assigned.

• Excellent understanding & ability to attain and maintain a working knowledge of ICH/GCPs

guidelines & SOPs.

• Demonstrated understanding of medical terminologies.

• Proficient in study planning activities, developing study time lines, CTMP, (IRB approval),

designing CRF, updating Investigational Brochures, Planning and conducting investigator

meetings.

• Expertise in creating and maintaining all the study initiation, study monitoring and study close

out documents like FDA from 1572, sponsor/CRO correspondence, Informed consent forms,

signed protocol and amendments, Financial aspects of trials, IRB approval form, drug

accountability and clinical study reports.

• Capable of reviewing the CRF forms for completion and correction according to sponsor

SOPs.

• Expertise in evaluating and selecting potential investigators who can proficiently conduct the

trials.

PROFESSIONAL EXPERIENCE

In House Sr. Clinical Research Associate

Company - Daiichi Sankyo Inc. Edison NJ (February 2014 – Present)

Therapeutic area: Cardio Vascular Phase 3b

• Monitor sites and ensure compliance with protocols and overall clinical objectives

• Participate in the design and development of clinical trial protocols, contracts, case report

forms, and study documentation

• TMF and essential document review and updated as monitoring plan

• Assist in the preparation of site initiation contract for PI, site budget contract, CRO/ARO/

responsibility and contract, clinical study reports and annual reports

• Assist in TMF project milestones timelines

• Assist in managing clinical studies to ensure studies are completed on time, within budget and

in compliance with SOPs, FDA regulations and ICH/GCP guidelines, NDA filling

• Perform activities of planning, implementing, motivating, co-monitoring, managing, and

tracking clinical trials

• Assist in the supervision of field monitors and Contract Research Organizations.

• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations

and study-specific manuals and procedures

• Track and report the progress of study including site activation, patient enrollment, and

monitoring visits

• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and follow-up

with study leadership to determine appropriate action

• Investigate queries, monitor discrepancies

• Manage investigational product (IP) pharmacy accountability and monetary compensation

contract and reconciliation process

• Responsible for review of IP release packages

• Contribute to preparation of clinical protocols, amendments, informed consent forms, study

guides, case report forms, study start up contract and any other clinical research related

documents

• Clinical data review of data listings and summary tables, including query generation

• In reference to FDA – 483. Participated in Adjudication process, root cause analysis and CAPA

process.

• Monitoring sites by weekly scheduled study coordinator meeting for open communication,

resolving issues / queries, requesting essential documents - 1572- wet ink documents - SSDL

- FDF for new PI / sub I.

• QCed data presented to FDA for final approval and uploaded QCed files to document control

department for archiving.

Clinical Research Associate II

Company: PAREXEL International, Durham NC (April 2012 –September 2013)

Therapeutic area: Oncology Phase II, III, Smoking Cessation Phase III and IV, Infectious Diseases

Phase III, DFU -Diabetic foot Ulcer Phase I, II, CHF – Congestive Heart Failure, Phase II and III

• Operating system experience –First Doc, Medidata Rave, Inform – ELARA – Oracle Clinical

(OCRDC), Epahrmasoution, RT II, Impact Harmony (IH)

• Oversee the Quality Control review of clinical trial patient databases and clinical files.

• Prepare and distribute Safety report, Protocol Amendment, management reports, ad hoc

reports, summaries, or analyses as required. Prepare status reports for assigned clinical

investigations.

• Prepare drug usage projections and tracking for assigned clinical investigations as

requested.

• Participate in the periodic review and revision of departmental policies and SOP's to assure

compliance with corporate policies, good clinical practice procedures (GCP's), or

regulations of governmental agencies. Assist with preparation and execution of

Investigator meetings.

• Maintain knowledge of U.S. and foreign regulations, guidelines, policies and practices for

conducting clinical investigations.

• Train, develop and supervise clinical site staff.

• Develop and review study protocols and CRF's.

• Review and participate in finalizing and obtaining approval of final study reports.

• Participate in dissemination of clinical information to the clinical team members, as

appropriate.

2

Clinical research associate II

Company: Ethicon Inc. (Johnson & Johnson co.) Somerville NJ (May 2009 – March 2012)

Therapeutic area: Dermatology – Disinfection – improved wound cleansing, phase II and III.

Fungicidal, virus inactivating phase III.

• Monitoring of assigned clinical investigations and coordinate/participate in the co-monitoring

of assigned clinical investigations as needed.

• Oversee the Quality Control review of clinical trial patient databases and clinical files.

• Prepare and distribute monthly management reports, ad hoc reports, summaries, or analyses as

required. Prepare status reports for assigned clinical investigations.

• Prepare drug usage projections and tracking for assigned clinical investigations as requested.

• Participate in the periodic review and revision of departmental policies and SOP's to assure

compliance with corporate policies, good clinical practice procedures (GCP's), or regulations of

governmental agencies.

Assist with preparation and execution of Investigator meetings.

• Assist with preparation of department budgets, timelines, and project plans.

• Maintain knowledge of U.S. and foreign regulations, guidelines, policies and practices for

conducting clinical investigations.

• Train, develop and supervise clinical staff.

• Negotiate contracts and budget for assigned clinical investigations.

• Develop and review study protocols and CRF's.

• Review and participate in finalizing and obtaining approval of final study reports.

Manager - QA/QC Lab.

Company: Presperse, Inc. Somerset NJ (January 2002– December 2008)

• Good negotiation, communication, organization, planning and problem solving skills.

• Participate in internal/external audits.

• Review and participate in finalizing and obtaining approval of final study reports.

• Preparing documentation such as raw material specifications, MSDS, TDS, TSCA, dossier,

SOP and other regulatory related documentation.

• Specs prep, CAPA implementation, OOS resolution, SOP compliance.

QA/QC in GMP/GLP

• Analyze raw material by US and EU pharmacopeias test methods

• Verified data assurance on QA/QC reports

• Customer’s problem resolved by visiting or teleconferencing with technical people

• Audited vendor facility for GMP/GLP compliance

3

Contact this candidate