1. Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed
2. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
3. Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
4. Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)
5. Manage local lab set up for the Clinical Database as applicable
Performs DM hands on activities during the course of the study
7. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
8. Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation
9. Supports and assists Junior staff for assigned trials
10. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
11. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
12. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
13. Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines
Key Performance Indicators (Indicate how performance for this job will be measured)
Achieve overall goals as set each year by Global Head, Data Operations, GDO and Group Head, Data Management
2. All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures
3. No critical audit findings due to Data Management
Do let me know if you are interested in the opportunity by sharing Updated Resume along with the below details to the email: [email protected]
· Total Years of exp
· Relevant Exp in Clinical Data Management & Medidata Rave.
· Current Location.
· Willing to relocate to Mumbai.
· Notice Period
▶️ Senior Clinical Data Manager -(5-8 yrs) Mumbai
Job Name : Customer Experience Salary : 18000 – 20000 a Months Exp: 0 – 2 years Company Name : HDFC...Apply For This Job
Job details Here’s how the job details align with your job preferences.Manage job preferences at any time in your profile....Apply For This Job
About technip energies At technip energies, we believe in a better tomorrow and we believe we can make tomorrow betterWith...Apply For This Job
The youngest of all the ILM studios, the India studio leverages the expertise and technological know-how developed over 40 years...Apply For This Job
Duties and responsibilities:Assist in creating test strategy for different application technologiesIdentifies automation opportunities in existing teamsTeam player capable of interacting...Apply For This Job
Job Title: Helpdesk IT Lead Company Overview Kudzu Infotech is a leading company in the Information Technology & Services industry....Apply For This Job