JOB VACANCIES: US JOB VACANCIES

Clinical Trial Document Management Specialist

Synmeta LLC New York (H1B Sponsorship Avaliable)

1 - 6 yrs

United States (U.S)

60,000 - 70,000 P.A Posted Today

Job Description

Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.

Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.

Support the CRA in the maintenance and close out activities for the ISF

Contribute to the production and maintenance of study documents, ensuring template and version compliance

Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Client Authoring Guide for Regulatory Documents to support publishing in GEL

Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).

Set-up, populate and accurately maintain information in Client tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems.

Salary:USD 60,000 - 70,000 P.A

IndustryVV: Medical / Healthcare / Hospitals

Functional AreaV:Medical , Healthcare , R&D , Pharmaceuticals ,Biotechnology

Role Category:R&D

Role:Clinical Research Associate/Scientist

Keyskills

Documents Document Managementdocument planning Clinical clinical specialistpharma specialistclinical technology and supportpharmaceutical specialist

Desired Candidate Profile

Education-

UG:Any Graduate - Any Specialization

PG:Any Postgraduate - Any Specialization, Post Graduation Not Required

Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required

Experience with electonic trial master file system(s) including uploading, reviewing, QC, approval of study required documents

Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines

Working knowledge of clinical study documents

Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

Good verbal and written communication

Good interpersonal skills and ability to work in an international team environment

Willingness and ability to train others on study administration procedures

Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Integrity and high ethical standards

Desired work experience (in complete years): Experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required.

Company Profile:

Synmeta LLC New York (H1B Sponsorship Avaliable)

IT & HealthCare

469 7th Ave, Suite 736
New York, NY 10018
Phone: 949-565-0222

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Websphere Developer

Synmeta LLC New York (H1B Sponsorship Available)

2 - 7 yrs

United States (U.S)

60,000 - 70,000 P.A Posted Today

Job Description

WebSphere Integration Developer will assist in implementing various IBM Integration Bus and Data power integration applications.

Enhance the existing SAP Maximo interfaces to implement new requirements

Work with Maximo and SAP Adapters

Collaborate with SAP and Maximo teams

Developing and consuming Web Services

Update design documents

Working with MQ objects

Testing Message flows

Develop comprehensive documentation for integration projects.

Salary:USD 60,000 - 70,000 P.A

Industry :Medical / Healthcare / Hospitals

Functional Area:IT Software - Embedded , EDA , VLSI , ASIC , Chip Design

Role Category:Programming & Design

Role:Graphic/Web Designer

Keyskills

Websphere Integration DeveloperWeb ServicesMQWeb Technologies

Desired Candidate Profile

Education-

UG:BCA - Computers, B.Tech/B.E. - Any Specialization, Computers, Electrical, Electronics/Telecommunication

PG:Any Postgraduate - Any Specialization, Post Graduation Not Required

Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Must have IIB 9.0 development skills (at least 1 implementation project)

ESQL, Java, XML (one or more of these)

Hands on experience on SAP interfacing is must and Maximo Integration experience is a big plus

Understanding of SAP BAPIs and IDOCS

Strong knowledge and understanding of the following products set:

IBM Integration Bus (version 9.0 or 10.0)

Data power Xi52 and XG45

WebSphere SAP Adapter

WebSphere MQ Services

Strong Software Development Life-Cycle methodology and SOA methodologies

Strong understanding of messaging practices, principles and standards.

Strong problem determination and problem solving and communication skills

Desired work experience (in complete years): 2-3 years of Message Broker/IIB development experience

Qualification- Bachelors degree in Computer Science, Engineering or other technical curriculum required.

Company Profile:

Synmeta LLC New York (H1B Sponsorship Available)

IT & HealthCare

469 7th Ave, Suite 736
New York, NY 10018
Phone: 949-565-0222

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Drug Safety Specialist

Synmeta LLC New York (H1B Sponsorship Available)

2 - 7 yrs

United States (U.S)

60,000 - 70,000 P.A Posted Today

Job Description

Conduct the review of all domestic and foreign SAE reports for all Syndax investigational products to make sure all important SAE elements are provided.

Ensure consistency in initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility.

Draft case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed.

Perform quality reviews of completed SAE reports received from contract drug safety vendors (CROs); transmit reports to Syndax business partners per timelines in safety data exchange agreements.

Exercise judgment and apply knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments of expectedness.

Generate appropriate queries to sites and/or contract drug safety vendors (CROs) to complete and clarify SAE case information; work with the CRO to determine when cases are complete and ready to close.

Collaborate with Regulatory personnel to communicate reporting of SAEs requiring expedited submission to Regulatory Authorities and to ensure appropriate reporting is performed per timelines.

Collaborate with cross-functional teams, Clinical Operations, Data Management and Biostatistics; participate in meetings and teleconferences with cross-functional teams, CROs, and business partners.

Deliver weekly or monthly metrics to supervisor efficiently, accurately and within agreed-upon timelines. Support supervisor with other SAE reporting and Pharmacovigilance Operations.

May assist in the preparation of safety sections for regulatory documents and in developing Safety forms, standard operating procedures and process guidelines.

May assist in signal detection activities and provide line listings for review.

Salary:USD 60,000 - 70,000 P.A

Industry :Medical / Healthcare / Hospitals

Functional Area :Medical , Healthcare , R&D , Pharmaceuticals ,Biotechnology

Role Category:R&D

Role:Clinical Research Associate/Scientist

Keyskills

Pharmacovigilance Drug SafetyClinical Operations Data ManagementStandard Operating Proceduresdrug specialistpharmacuiticles specialist

Desired Candidate Profile

Education-

UG:B.Sc - Nursing, Other Specialization, B.Pharma - Pharmacy, Other Graduate

PG:Any Postgraduate - Any Specialization, Post Graduation Not Required