Lead Data Manager (Expert in working & developing EDC systems)

Pune - India

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Department:

Data Management

Job Summary

The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.
The Lead Data Manager represents a position under direction of the Director of Data Management.
Provide updates for Data Management during internal/client team meetings and communication if required.
Provides metric reports for internal/external project team
Meets with the Project Manager to work on completing the study objectives in a timely manner
Provides training of other DM staff on project specific processes
Provides feedback to other project team members and managers to improve the deliverables
Authors or reviews data management documentation including the Data Management Plan
Data Review Plan eCRF Completion Guidelines and others as needed
Supports build design and testing of EDC study designs
Creates listings/reports using ad hoc reporting tools across multiple EDC systems
Communicates any project risks or possible quality issues to the Project Manager
May work on projects across multiple trial EDC platforms
Maintains project files and ensures full traceability of all processes and documentation
Manages Lab ranges across the entire study
Performs data management activities such as data review serious adverse event reconciliation third party electronic data (e.g. laboratory PK diary) reconciliation and query management
Oversees the issuing of queries and reviews query responses with the highest level of quality
Perform DM and/or EDC activities if needed provided the required experience and background are in place

Qualifications :

3-5 years of relevant experience in pharmaceutical industry and/or contract research organization specifically in data management.

Experience in working with and developing EDC systems (e.g. Merative Zelta Medrio Medidata RAVE iMednet Datatrial) Proficiency in computer applications: Windows Excel Word Outlook etc.

Medidata RAVE and/or Zelta Certification is an asset.

Additional Information :

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly supportive working environment
Opportunity to work with colleagues based all over the world with English as the company language

Our core values are key to how we operate and if you feel they resonate with you then Ergomed is a great company to join!

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.

#LI-Remote

Remote Work :

Yes

Employment Type :

Full-time

The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.The Lead Data Manager represents a positio...

The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.
The Lead Data Manager represents a position under direction of the Director of Data Management.
Provide updates for Data Management during internal/client team meetings and communication if required.
Provides metric reports for internal/external project team
Meets with the Project Manager to work on completing the study objectives in a timely manner
Provides training of other DM staff on project specific processes
Provides feedback to other project team members and managers to improve the deliverables
Authors or reviews data management documentation including the Data Management Plan
Data Review Plan eCRF Completion Guidelines and others as needed
Supports build design and testing of EDC study designs
Creates listings/reports using ad hoc reporting tools across multiple EDC systems
Communicates any project risks or possible quality issues to the Project Manager
May work on projects across multiple trial EDC platforms
Maintains project files and ensures full traceability of all processes and documentation
Manages Lab ranges across the entire study
Performs data management activities such as data review serious adverse event reconciliation third party electronic data (e.g. laboratory PK diary) reconciliation and query management
Oversees the issuing of queries and reviews query responses with the highest level of quality
Perform DM and/or EDC activities if needed provided the required experience and background are in place