www.medpace.com Clinical Research India Pvt Ltd Navi Mumbai : Laboratory Director CRO Clinical Research

[mskavi]

Medpace Clinical Research India Pvt. Limited Navi Mumbai : Laboratory Director at Medpace Reference Labs
Website: http://www.medpace.com
medpace.com

Designation: Laboratory Director at Medpace Reference Labs
Experience: 1 - 5 Years
Location: Navi Mumbai

Job Description:
The Laboratory Director is responsible for the overall operation, leadership, direction, and administration of the Clinical Laboratory in accordance with Federal Regulations governing clinical laboratories.
Duties and Responsibilities of this Level
Plan, develop, organize, implement, direct and evaluate the organization's laboratory operations and performance.
The Laboratory Director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulation.
Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.
Ensure that the physical plant and environment conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards
Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care; verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method; and laboratory personnel are performing the test methods as required for accurate and reliable results.
Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.
Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified and that test results are reported only when the system is functioning properly.
Ensure that reports of test results include pertinent information required for interpretation.
Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.

Employ a sufficient number of laboratory personnel with appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results.
Ensure that prior to testing specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process
Establish operations standards for cost control, waste reduction, quality, safety, and complete on-time delivery.
Oversee the development of the organization's plans and programs in evaluation of long-range planning and regulatory action on operational performance. Foster a unified culture and promotes a process for collaboration, cooperation, sharing of information and mutual teamwork.
Monitor utilization patterns of lab services and advises Leadership and other appropriate staff of developing trends in clinical service needs.
Establish and maintain lines of communication with internal and external customers in order to ensure a timely response to new clinical service trends and program planning.
Ensure operational adherence to currently accepted technical service standards for laboratory medicine.
Ensure operational adherence to applicable policies and procedures by all technical and operational staff.
Participate in the development and implementation of operations budget to ensure compliance with organizational expenditure requirements.
Lead and direct the development, communication and implementation of effective growth strategies and processes.
Perform other duties as required.
Perform other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state or federal regulations.


Desired Candidate Profile:
Candidate should have specialist training in Laboratory Medicine with work experience. MRCPath candidates will have an edge.

Company Profile:
Medpace is a global, full-service clinical development company with medical and regulatory expertise in multiple therapeutic specialties. Regulatory experts provide valuable foresight and guide decision making throughout the entire development process. Beginning from program design they maintain an unwavering focus on the goal of regulatory approval. Medpace also provides its customers the strategic counsel, highly knowledgeable clinical development staff, and comprehensive support services necessary to conduct efficient and integrated global development programs. With operations in over 40 countries, Medpace has the global reach to conduct studies and navigate regulatory requirements worldwide.

Major Services
The Medpace approach creates a therapeutically focused project team, increasing the quality of every service, including the following:
* Medical Expertise
* Regulatory Affairs
* Safety/Pharmacovigilance
* Clinical Operations
* Data Management
* Biostatistics
* Quality Assurance
* Medical Writing
* Cardiac Safety
* Interactive Voice Response System

Areas of Expertise
* Cardiology
* Endocrinology
* Metabolism
* Oncology
* CNS

Keywords: Laboratory Director CRO Clinical Research

[aloshree]

Application for a suitable post matching my profile in your esteemed organisation.

[Raniji]

Respected Sir/Madam,

Myself Rani Ghadge Completed my M.pharm in Pharmacology and having One year and two months experience in CRO.
I am sending my resume to you please consider for the Clinical Research post in your well esteemed organisation.

Thanks & Regards

Rani Ghadge
(+91-9890329590

[vidyaballal]

HI, I M VIDYA I M LOOKING FORE A JOB REGARDING CLINICAL RESEARCH. IF YOU HAVE ANY VACANCIES IN YOUR COMPANIES PLZ LET ME KNOW. I M FRESHER . PLZ REPLY SOON.

[Guest Poster]

Dear Sir, I am sending my CV herein with this....if you find it suitable kindly let me know...
Regards,

[Pravin Pawar]

I am Pravin Pawar(B.sc.P.G.D.M.L.T.) applying for the post of Patho Technologist. Presently i am working as Technologist in a Accutest research laboratories(Clinical Research)Khairne M.I.D.C.Navi Mumbai. Contact
E-mail:mailtopravin.pawar@rediffmail.com
mobile No:9757315642

[nirmalapwr@gmail.com]

i have complited M.Sc. in clinical research and regulatory affairs in sikkim manipal university. now i am searching a job in clinical research.

[Guest]

Respected madam/sir,
I AM BSC(GRADUATE) AND I HAVE COMPLETED POST GRADUATION IN CLINICAL RESEARCH MANAGEMENT & REGULATORY AFFAIRS. I AM FRESHER AND I AM INTERESTED TO WORK IN A CLINICAL RESEARCH

[Guest]

hi im shelar S K i have 6 yrs. exp.in pathological lab.

[Guest]

Respected authority,
my self praful telvekar . i have completed my mba-clinical research degree..and looking forward career in cro field, i am attaching my cv along with this request.
pls have a look and let me know if i am fulfilling your's requirement..
your's faithfully
Praful N. Telvekar

[Guest]

Respected sir,
Sir my self chemte sandip I am complied my M. pharmacy in pharmacology. So, please consider my resume for a job.

[Guest]

Hello
I would like to apply for clinical research/ clinical research coordiantor post in your esteemed company.please find my resume
Name : Jonaki Roy
email -jnkroy AT yahoo.com
objective
To be a part of an organization that is innovative and continuously strives for improvement in projects and processes. One in which I can contribute my knowledge and skills for the growth of an organization and to be able to implement solutions that meet the customer requirements using my technical expertise and domain knowledge.
Clinical trial and data Management Knowledge :
- CRF Designing, Database designing, Database Testing (User Acceptance Test), Edit Check Specification, Writing language, Edit Check Testing, Data entry, Data Validation, Database Quality Control.
- Knowledge on Medical Coding and 21 CFR Part 11.
- Aware of Data Validation procedures and database Closure.
- Ability of Query Resolution.
- Aware of CDISC , CDASH and Q.A., Q.C. In CDM.
- Clinical trial management with site monitoring, site feasibility, PI selection, source document verifications, Adverse event reporting, Drug shipment and accountability , timely site coordination ,training to site personnel for protocol, study plan, CRF entry, maintaining and updating TMF, etc.
- The Principles of ICH-GCP Guidelines, Schedule – Y.
- Bioequivalence/Bioavailability studies in Drug Development process.
job experince
Clinical Trial Coordinator.
Worked as CRC in Risk Care & Prakruti Hospital for Clinisearch CRO Thane.
Role and Responsibilities : As a Clinical trial Coordinator.(Oct 2011-dec2011)
- Collecting history of the patient and performing appropriate screening according
to the inclusion/exclusion criteria.
- Followed ICF procedure during patient recruitment for study.
- Ability for query resolution & DCF resolution.
- Observation of Subject during follow up visits with .
- AE/SAE documentation & reporting while conducting study .
- Coordinate trial related activities with the CRA.
- Coordinate with the patients & doctor for trial related activities.
- Maintaining Site Master File ,drug accountability log, Source documents and IP storage in hospitals
- Assignment includes ethics Committee Approval, Screening, Recruiting, Monitoring visits of Patients,, Monitoring SAE’s and AE’s.
Active Participation in below Studies as CRC :
- A Multicentric, randomized, open label,,prospective two arm , comparative study in treatment of lower respiratory tract infection.
- A multicentric, randomized,open label, comparative study to evaluate the safety and efficacy in treatment of type II diabetes
- Convergys Corporation Thane
As Senior Customer Care Officer Aug 2008- Apr 2009
- Spryance India(Transcend) Pune
As Home-Based Medical Transcriptionist Mar 2007 –Aug 2008
And as Proof Reader Aug 2010 Feb 2011.
- Reliance Info Streams Pvt Ltd. Navi Mumbai
As Customer Care Representative Dec 2003-June 2005
Educational Qualification
Year passed
Degree/Dipl Subjects % School/College
1998 SSC Sci, Maths, Eng, French Hindi 73 % KHS pune
1990 HSC Science, Maths 56 % Fergusson College Pune
1995 Bsc Bot,Geo,biochemChemistry(main) 59 % Pune University.
2007
Diploma in MT Medical Transcription 82% Spryance Pune
2010-2011
April 2012 Post graduation in clinical & Data mngt
Pursing Certification for CRA Clinical research &
Clinical data management
67 % ICRI Mumbai
Veritas Healthcare Solutions New York