Urgent Requirement on Lead Clinical Data Managers @ East Hanover, NJ

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  Lead Clinical Data Managers

 

LEAD CLINICAL DATA MANAGERS

Location: East Hanover, NJ

Type : Contract to Hire Position/Full Time

 

To Lead and Manage project activities at Study level at assigned client sites for Clinical Data Management and ensure efficient coordination among Study Teams and Data Management Teams.

 

JOB SPECIFICATIONS

 

1. Qualification

Graduate / Post-Graduate degree in Life Sciences/ Pharmacy/Project Management

Over 6 years of total experience with organization including over 3-5 years as a clinical data manager.

 

2. Special Skills and Knowledge

ICH - Good Clinical Practice

Detailed breadth of CDM experience and knowledge

Understanding of clinical trial and systems regulations for key health authorities

Ability to lead/supervise a team as well as mentor / direct team members

Overall advanced knowledge of Clinical Trial Methodology

Advanced Project Management Skills experience

Good knowledge of drug development process

Demonstrated strong focus on Quality

Demonstrated ability to support team members through Coaching & Mentoring

Good attention to Detail

 

Key Competencies

Leadership

Listening, Communication

Negotiation / Influencing

Communication Skills – Written & Verbal

Problem Solving & Decision Making

Risk Management

Proactive

Flexible

 

JOB ROLE

 

Key Accountabilities:

- Act as a single point of contact for all data management center deliverables during the Study Set-up, conduct and close-out phases

- Create/Provide input to project Data Management Plan

- Provide input/review the DM components in the protocol.

 

Creation of the Case Report Form from global standards and creation of protocol specific case report form modules by coordinating with sponsor’s protocol team and review of the same

 

- Accountable for the creation/review/maintenance of the CRF completion guidelines, edit check specifications leveraging global standard validations

- Accountable for database review, testing and UAT of edit checks for assigned studies

- Accountable for monitoring study progress and timely locking and freezing of database.

- Responsible for Project Management of the study and accountable for all study deliverables from end to end.

- Ensure adherence to Client SOPs

- Provide guidance and supervision to the study teams.

- Clarify, manage and successfully implement customer expectations, resolving conflicts whilst pursuing win-win scenarios

- Monitor quality and efficiency across functions to identify trends and opportunities for improvements. Ensure sharing of learning across geographies

- Manage relationships with Client at both the operations level and with functional peers

- Ensure project milestones are met according to agreed upon timelines with high quality

- Coordinate and work closely with offshore Trial Data Managers/Therapeutic Area Managers to ensure that study deliverables are met as per the timelines and with high quality.

- Review resource estimates for data management activity for allocated studies

- Participate in Study Kick Off meetings and lead all study related meetings during the Study Set-up phase /Conduct/Close out.

- Support both protocol and procedural training to external vendors and investigator’s site whenever required

- Coordinate to provide support for Data Safety Monitoring Board and all other vendors including Investigator’s site and the clients internal teams

- Act the as primary contact for all data management problems, issues and questions from study teams and be responsible for issues resolutions

- Responsible for tracking the various data management activities using study reports/metrics.

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

Regards,

Chandra

Nixsol Inc.|  53 Knightsbridge Road Suite # 216 |  Piscataway, NJ 08854. | Open Jobs : Nixsol Jobs Blog

Office: (732)-832-7933 |  Fax: (732)-909-2424 |  Email: chandra@nixsol.com   | Gtalk : AccMgrInUSA |  www.nixsol.com 

“If you look at what you do not have in life, you don't have anything, if you look at what you have in life, you have everything”

 

 

Urgent Requirement on Java Architect @ Harrisburg, PA

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  Java Architect

 

Job Title :Java Architect

Location : Harrisburg, PA

Duration : Long term

 

Either Phone or In Person

 

The software application is a Java-based web application.  It uses JBoss Seam as the framework with Java Persistence API (JPA)/Hibernate as its persistence layer.  has implemented its system using a PostgreSQL database for the data repository.  DEP plans to use an Oracle database instead of a SQL Server database.  Therefore, the system will be evaluated using an Oracle database.

 

·         Experience architecting and developing web applications using Java-based frameworks with a strong knowledge of Java 1.5 EE, JDK 1.6 and later Required 3 Years

·         Experience developing web applications using the JBoss Seam framework  (Seam 2.2.0.GA using POJOs) Required 1 Years     

·         Experience using Hibernate 3.x JPA/EJB3, JavaServer Faces (JSF 1.2), Facelets, RichFaces, Maven and Ant  Required 6 Months             

·         Exp w/web server/application server setup to run a J2EE app, and reconfigure an app for multiple deployment env such jBoss and Oracle WebLogic Required

·         Experience developing applications against Oracle 11gR2 databases Required 1       Years              

·         Ability to write SQL Data Definition Language (DDL) scripts to create and manage Oracle database schema objects (tables, views, indexes, constraints) Required1 Years

·         Experience using SQL Data Manipulation Language (DML) to query and perform insert, update and delete activities in an Oracle database Required 2 Years

·         Experience using Microsoft Active Directory or Lightweight Directory Access Protocol (LDAP) Required 3 Months         

·         Good people skills and be able to effectively communicate business requirements with the Client staff as well as technical requirements with BIT staff

 

**Skill matrix**

Required  Skills                                                                                                                               Years of Experience                  Last Used

Experience architecting and developing web applications using Java-based frameworks with a strong knowledge of Java 1.5 EE, JDK 1.6 and later _________

Experience developing web applications using the JBoss Seam framework  (Seam 2.2.0.GA using POJOs) ____________

Experience using Hibernate 3.x JPA/EJB3, JavaServer Faces (JSF 1.2), Facelets, RichFaces, Maven and Ant  __________________

Exp w/web server/application server setup to run a J2EE app, and reconfigure an app for multiple deployment env such jBoss and Oracle WebLogic __________

Experience developing applications against Oracle 11gR2 databases ________________-          

Ability to write SQL Data Definition Language (DDL) scripts to create and manage Oracle database schema objects (tables, views, indexes, constraints) _____________

Experience using SQL Data Manipulation Language (DML) to query and perform insert, update and delete activities in an Oracle database ______________

Experience using Microsoft Active Directory or Lightweight Directory Access Protocol (LDAP) _____________

Good people skills and be able to effectively communicate business requirements with the Client staff as well as technical requirements with BIT staff____________

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

Regards,

Chandra

Nixsol Inc.|  53 Knightsbridge Road Suite # 216 |  Piscataway, NJ 08854. | Open Jobs : Nixsol Jobs Blog

Office: (732)-832-7933 |  Fax: (732)-909-2424 |  Email: chandra@nixsol.com   | Gtalk : AccMgrInUSA |  www.nixsol.com 

“If you look at what you do not have in life, you don't have anything, if you look at what you have in life, you have everything”

 

 

Urgent Requirement on Website Programmer @ Little Rock, AR

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  Website Programmer  

 

Job Title :Website Programmer  

Location : Little Rock, AR   

Duration : Long Term

 

Local Candidates are preferred.

 

 The Web Programmer will be responsible for the analysis, design, coding, development, testing, documentation and implementation for the website redesign.

    

Required Knowledge, Abilities, and Skills

    •             Extensive knowledge and use of PHP, MySQL, ColdFusion, Javascript, XHTML, HTML, XML, CSS, and jQuery.

    •             Expertise with Drupal site administration.

    •             Expert-level, hands-on experience configuring Views, CCK, Taxonomy, Nivo Slider, Date, Calendar, Content Access, Webform, Node Reminder, Pathauto, Nice Menus, Node Reference and other Drupal contributed modules.

    •             Familiar with Drupal database abstraction layer.

    •             Familiar with Drupal template system.

    •             Experience with Zen Theme.

    •             Knowledge of and demonstrated experience with cross-browser and cross-platform issues.

    •             Experience with Dreamweaver.

    •             Experience with Adobe Photoshop or an equivalent program.

    •             Experience with Windows Server administration.

    •             Experience with Microsoft IIS (user administration and security).

    •             Excellent verbal and written communication skills.

    •             Ability to communicate across agencies and with other divisions within agency.

    •             Ability to communicate with both highly technical and non-technical personnel.

    •             Strong technical/analytical skills

    •             Highly organized with demonstrated ability to multi-task.

    •             Strong team player, self-starter, goal oriented, quick learner.

    •             Willingness to learn new tools and techniques for web development.

    

    Examples of Work

    •             Maintain and coordinate multiple web projects.

    •             Migrate website to Drupal technology.

    •             Document requirements of design and architecture of software to meet business requirements.

    •             Coordinate Web Committee activities.

    •             Train department users to maintain current information.

    •             Ensure the accuracy and currency of the Arkansas Judiciary website.

    •             Work with the appellate courts and ancillary agencies to improve web functionality.

    •             Write SQL queries to select, update, insert and delete information from a MySQL database.

    •             Create PDF documents and forms.

    

 Required  Details

Web Development Programming     Required         5          Years    

PHP, MySQL, ColdFusion, Javascript Required         3          Years    

XHTML, HTML, XML, CSS, and jQuery            Required         3          Years                

Drupal (all aspects)     Required         3          Years    

Zen Theme     Required         3          Years                

Photoshop, Illustrator, Fireworks, Flash, Dreamweaver       Required         3          Years    

Windows Server Administration        Required         3          Years                

Microsoft IIS (user administration and security)        Required         3          Years    

Project Leadership      Required         2          Years                

Excellent Communication Skills          Required                     Years

Describe/Outline the process for converting data from a SQL Server database to an Oracle database

 

**Skill matrix**

Required  Skills                                        Years of Experience                  Last Used

Web Development Programming ________________________

PHP, MySQL, ColdFusion, Javascript ______________________

XHTML, HTML, XML, CSS, and jQuery            ______________________     

Drupal (all aspects)     _________________________________

Zen Theme     __________________________         

Photoshop, Illustrator, Fireworks, Flash, Dreamweaver ______________________________       

Windows Server Administration _______________________________                  

Microsoft IIS (user administration and security)        ________________________________

Project Leadership      __________________________________

Excellent Communication Skills          _______________________________

Describe/Outline the process for converting data from a SQL Server database to an Oracle database__________-

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

 

 

Regards,

Chandra

Nixsol Inc.|  53 Knightsbridge Road Suite # 216 |  Piscataway, NJ 08854. | Open Jobs : Nixsol Jobs Blog

Office: (732)-832-7933 |  Fax: (732)-909-2424 |  Email: chandra@nixsol.com   | Gtalk : AccMgrInUSA |  www.nixsol.com 

“If you look at what you do not have in life, you don't have anything, if you look at what you have in life, you have everything”

 

 

Urgent Requirement on Functional Oracle eBS Financials @ Wheeling, IL

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on Functional Oracle eBS Financials 

 

Job Title :Functional Oracle eBS Financials

Duration : 2 months

Location :  Wheeling, IL

Type : Phone interview

 

 

 

 Project Description:

Strong R12 experience, experience moving from a 11i environment to 12 is great.  Strength in GL and Sub ledger accounting.  This person needs to be outgoing, strong communication skills to be able to speak to users and ask questions is a must.

 

Requirements:

 

    Must have  3+ years of Oracle GL  functional requirements gathering and configuration experience

    Strong experience with Sub ledger accounting

    Must have experience with eBS R12

    Must be able to interface effectively with all levels of the organization.

    Must have excellent interpersonal skills and be strong and effective communicator and listener.

    Good writing skills and ability to multi task in the support of this project.

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

 

Regards,

Chandra

Nixsol Inc.|  53 Knightsbridge Road Suite # 216 |  Piscataway, NJ 08854. | Open Jobs : Nixsol Jobs Blog

Office: (732)-832-7933 |  Fax: (732)-909-2424 |  Email: chandra@nixsol.com   | Gtalk : AccMgrInUSA |  www.nixsol.com 

“If you look at what you do not have in life, you don't have anything, if you look at what you have in life, you have everything”

 

 

Urgent Requirement on IT Services Support Analyst @ Richmond, Virginia

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  IT Services Support Analyst

 

Role Title: Technical Support 2   

Work Title:  IT Services Support Analyst

Location : Richmond, Virginia 

Years of Experience: 4-7 years of experience in the field or in a related area.

 

 

**local candidates strongly preferred

***personal interview required, no exception

 

Job Description:

Familiar with standard concepts, practices, and procedures within the IT customer service arena with emphasis on Desktop Support and Microsoft Outlook.  Relies on limited experience and judgment to plan and accomplish goals. A certain degree of creativity and latitude is required. Works under limited supervision with considerable latitude for the use of initiative and independent judgment.

 

Assists in monitoring and providing assistance on the use and interface of IT inventory systems, subsystems, and software applications. May be responsible for accessing data from IT inventory systems and transferring data for Agnecy use.  Knowledge of the practices, principles, and techniques of computer operations, of information systems, of computer software and hardware, and of information security policies and procedures. Skill in the use and support of personal computers, in the use of applicable programs and systems, and in troubleshooting information systems.

 

Ability to operate information technology systems and to communicate effectively, and to train customers.  Prepares briefings and reports.

 

Specific Job Responsibilities:

 

Assisting DMASers with mailbox clean-up/organization effort.

Assisting DMASers with desktop profile organization pre and post IT transformation.

Assisting IT Services and DMAS OCS with Agency tasks as asked by the VITA/NG IT Partnership.

Validating the desktop computing footprint prior to the MDS workstation cut-over from the DMAS legacy domain to the COV Commonwealth domain.

Responding to IT customer service events.

 

IT Desktop Support Expereince including direct contact with the customer.         Required         4          Years    

IT Support Expereince with a strong understanding of Microsoft Outlook and email archiving methods             Required         4          Years    

IT Hardware and Software Inventory expereince    Highly desired             2          Years    

Active Directory layout and organization     Nice to have   2          Years    

Domain Migration Expereince           Nice to have   2          Years                

Must have excellent communication and customer service/support skills

 

**Skill matrix**

Required  Skills                                                                                                                   Years of Experience      Last Used

IT Desktop Support Expereince including direct contact with the customer.__________________

IT Support Expereince with a strong understanding of Microsoft Outlook and email archiving methods             _________________

IT Hardware and Software Inventory expereince    _________________________

Active Directory layout and organization     _______________________

Domain Migration Expereince ___________________________     

 

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

 

Regards,
Chandra K.

Nixsol Inc.,
53 Knightsbridge Road

Suite # 216

Piscataway, NJ 08854.
(:(732)-832-7933
6:(732)-909-2424
*:chandra@nixsol.com

Gtalk & IM: AccMgrInUSA

Open Jobs : Nixsol Jobs Blog

Note: Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include contact information and a remove link for removal from our mailing list. To be removed from our mailing list reply with 'remove' and include your 'original email address / addresses' in the subject heading and Include complete address/addresses where our mail is received. We will immediately update it accordingly. We apologize for the inconvenience if any caused. Thank you.

“We treat others as we wish to be treated”

 

Urgent Requirement on .net Programmer @ Ewing, NJ

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  .net Programmer

 

Title .net Programmer

Location: Ewing, NJ

Duration: 3 months

 

Local preferred  

 

This senior .NET developer will have excellent technical and communication skills. This contractor will assist us with our projects involving C#, ASP.NET, MS SQL Server etc.

 

Selected staff will deliver completed system documentation including system requirements and work flow analysis document, design and program specification documents, and test plans. Also candidate will deliver code modules (C#, ASP.NET, SSRS, MS SQL Server, etc…) as assigned, and conduct code reviews, and provide status reports to project manager and project lead.

 

Coding, testing, and debugging in NET 4.0, Entity FW                                          Required         5         Years    

Classical n-Tier architecture                                                                                          Required         3          Years    

SOA ( Service Oriented Architecture)                                                                        Required         3          Years                

Building pages with C# code behinds that consume data from SQL Server     Required         3          Years    

Building and consuming web services                                                                     Required         3          Years                

Effective web page design and coding                                                                    Required         3          Years    

Understanding user controls                                                                                      Required         4          Years                

Coding using .NET Generic classes                                                                           Required         2          Years    

Normalization, keys, and indexes, and basic tuning                                             Required         3          Years             

Design/create/alter SQL Tables                                                                                Required         3          Years    

writeUse views, stored procedures, and functions                                                Required         2          Years                

Write queries using LINQ Syntax                                                                              Required         2          Years    

                                                                                                 

HTML, CSS and Javascript

 

Required / Desired Amount of Experience

 

Coding, testing, and debugging in NET 4.0, Entity FW : __________

Classical n-Tier architecture  : ____________

SOA ( Service Oriented Architecture) : ___________

Building pages with C# code behinds that consume data from SQL Server  :________

Building and consuming web services  :___________

Effective web page design and coding  :___________

Understanding user controls    : ___________

Coding using .NET Generic classes  : _______________

Normalization, keys, and indexes, and basic tuning  :______________

Design/create/alter SQL Tables  : ________________

writeUse views, stored procedures, and functions : ____________

Write queries using LINQ Syntax: _________________

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

 

Regards,
Chandra K.

Nixsol Inc.,
53 Knightsbridge Road

Suite # 216

Piscataway, NJ 08854.
(:(732)-832-7933
6:(732)-909-2424
*:chandra@nixsol.com

Gtalk & IM: AccMgrInUSA

Open Jobs : Nixsol Jobs Blog

Note: Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include contact information and a remove link for removal from our mailing list. To be removed from our mailing list reply with 'remove' and include your 'original email address / addresses' in the subject heading and Include complete address/addresses where our mail is received. We will immediately update it accordingly. We apologize for the inconvenience if any caused. Thank you.

“We treat others as we wish to be treated”

 

Urgent Requirement on Technical Project Manager - Web @ Richmond, Virginia

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  Technical Project Manager - Web  

 

Technical Project Manager - Web  

Location : Richmond, Virginia 

Duration : 1 + Year  

 

Job Description:
A project Manager will work with Client  to develop Microsoft Project Plan to track transition applications and websites from one vendor to multiple vendors.  The PM will need excellent communication skills, application development knowledge.  Must be excellent working in team environment, working with customers, and be able to handle some decision making.  

Skills:
2-5 years demonstrated Project Management to include the following

·         to coordinate activities to meet project deadlines and budgets.

·         Knowledge of BA skills for understanding an documenting user requirements.

·         Position requires extensive knowledge and leadership experience in web applications; development, tools, and software, including payment processing protocols.

·         Ability to work with technical and non-technical people often conveying complex technical information.

·         Excellent verbal communication skills.

·         Experience in working on multiple projects with an extensive variety of stakeholders and multiple vendors.

·         Demonstrated skills in building effective, professional relationships across a broad spectrum of roles including customers, stakeholders, technical teams, and vendors.

·         Knowledge of web and payment portals, payment methods, electronic gateways, and associate web tools.  

·         Knowledge of system architectural design of hardware for hosting environments required to support web applications.

 

ü  5-10 years - demonstrated ability to use Microsoft Office such as Microsoft Excel.
5-10 years Application development to include the following

ü  Knowledge of the following tools/platforms:  Perl 5; Visual Studio 2003, 2005, 2008, 2010; Adobe Captivate; Adobe Life Cycle, or equivalent tools.

ü  Practiced in the following programming languages:  VB.Net; C#.Net; Asp; Flex

ü  Knowledge of Database such as Informix, SQL, Oracle and familiar with database normalization.

Education and certifications
Degree in information technology or related field desirable; other education and/or progressive experience may substitute.
PMP certified at least 2 years - (Must be current). 

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

Regards,
Chandra K.

Nixsol Inc.,
53 Knightsbridge Road

Suite # 216

Piscataway, NJ 08854.
(:(732)-832-7933
6:(732)-909-2424
*:chandra@nixsol.com

Gtalk & IM: AccMgrInUSA

Open Jobs : Nixsol Jobs Blog

Note: Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include contact information and a remove link for removal from our mailing list. To be removed from our mailing list reply with 'remove' and include your 'original email address / addresses' in the subject heading and Include complete address/addresses where our mail is received. We will immediately update it accordingly. We apologize for the inconvenience if any caused. Thank you.

“We treat others as we wish to be treated”

 

Direct Client Urgent Requirement on Lead Clinical Data Managers @ East Hanover, NJ

Hello Dear, Greetings.

This is Chandra from Nixsol Inc.,

 

We have an Urgent Requirement on  Lead Clinical Data Managers

 

LEAD CLINICAL DATA MANAGERS

Location: East Hanover, NJ

 

To Lead and Manage project activities at Study level at assigned client sites for Clinical Data Management and ensure efficient coordination among Study Teams and Data Management Teams.

 

JOB SPECIFICATIONS

 

1. Qualification

Graduate / Post-Graduate degree in Life Sciences/ Pharmacy/Project Management

Over 6 years of total experience with organization including over 3-5 years as a clinical data manager.

 

2. Special Skills and Knowledge

ICH - Good Clinical Practice

Detailed breadth of CDM experience and knowledge

Understanding of clinical trial and systems regulations for key health authorities

Ability to lead/supervise a team as well as mentor / direct team members

Overall advanced knowledge of Clinical Trial Methodology

Advanced Project Management Skills experience

Good knowledge of drug development process

Demonstrated strong focus on Quality

Demonstrated ability to support team members through Coaching & Mentoring

Good attention to Detail

 

Key Competencies

Leadership

Listening, Communication

Negotiation / Influencing

Communication Skills – Written & Verbal

Problem Solving & Decision Making

Risk Management

Proactive

Flexible

 

JOB ROLE

 

Key Accountabilities:

- Act as a single point of contact for all data management center deliverables during the Study Set-up, conduct and close-out phases

- Create/Provide input to project Data Management Plan

- Provide input/review the DM components in the protocol.

 

Creation of the Case Report Form from global standards and creation of protocol specific case report form modules by coordinating with sponsor’s protocol team and review of the same

 

- Accountable for the creation/review/maintenance of the CRF completion guidelines, edit check specifications leveraging global standard validations

- Accountable for database review, testing and UAT of edit checks for assigned studies

- Accountable for monitoring study progress and timely locking and freezing of database.

- Responsible for Project Management of the study and accountable for all study deliverables from end to end.

- Ensure adherence to Client SOPs

- Provide guidance and supervision to the study teams.

- Clarify, manage and successfully implement customer expectations, resolving conflicts whilst pursuing win-win scenarios

- Monitor quality and efficiency across functions to identify trends and opportunities for improvements. Ensure sharing of learning across geographies

- Manage relationships with Client at both the operations level and with functional peers

- Ensure project milestones are met according to agreed upon timelines with high quality

- Coordinate and work closely with offshore Trial Data Managers/Therapeutic Area Managers to ensure that study deliverables are met as per the timelines and with high quality.

- Review resource estimates for data management activity for allocated studies

- Participate in Study Kick Off meetings and lead all study related meetings during the Study Set-up phase /Conduct/Close out.

- Support both protocol and procedural training to external vendors and investigator’s site whenever required

- Coordinate to provide support for Data Safety Monitoring Board and all other vendors including Investigator’s site and the clients internal teams

- Act the as primary contact for all data management problems, issues and questions from study teams and be responsible for issues resolutions

- Responsible for tracking the various data management activities using study reports/metrics.

 

Give me the details listed below:

Full Name:
Availability to start-----:
Availability for interview:
Visa Status (US Citizen, GC Holder, H1b or TN holder): 
Contact Number:
E-mail Address:
Re-location:
Current Location (Place & State):
Last 4 SSN:
(Date of Birth) Date & Month:
2 Professional References  (Name/ Project Name/ Title/Email ID/ Contact number):

 

Regards,

Chandra

Nixsol Inc.|  53 Knightsbridge Road Suite # 216 |  Piscataway, NJ 08854. | Open Jobs : Nixsol Jobs Blog

Office: (732)-832-7933 |  Fax: (732)-909-2424 |  Email: chandra@nixsol.com   | Gtalk : AccMgrInUSA |  www.nixsol.com 

“If you look at what you do not have in life, you don't have anything, if you look at what you have in life, you have everything”