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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