SPE-Clinical Data Management
Place of work
Work from home
Job details
Job description, work day and responsibilities
JD CDM:
• 2 to 3 yrs of minimum Clinical Data Management experience
• Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases.
• Rave (Medidata) or Veeva EDC hands on experience is must.
Must Have:
Setup experience should have knowledge of
DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory).
Conduct Experience
Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc.
Study Lock
Freezing/Locking, should have good experience of Study lock
Client facing role and Mentoring are added advantage.
1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities.
2 Participate in innovation and process improvement initiatives.
3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs.
4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.
5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
6 Study Setup hands on experience.
7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool ,
8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication)
The position is suitable for candidates with education
This position is suitable for fresh graduate
You will be redirected to another website to apply.
Offer ID: #1226892,
Published: 18 hours ago,
Company registered: 2 months ago
