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 

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