Job Purpose:

1. Provides Clinical Research Data Management (DM) leadership and subject matter expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study and projects.

2. Serves as a member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation.  This includes, but is not limited to the Data Management Plan (DMP) and the Data Quality Plan (DQP).

3. Be responsible for the overall quality and integrity of the database with respect to “Critical to Quality” (CTQ) data points predefined by Clinical and Biostatistics prior to the start of a study.

4. The position holder will project manage the DQP to ensure CTQ data points are of the highest integrity and completeness.

Role & Responsibility:

1. Serves as the expert in Clinical Research Data Management (DM) to provide oversight and advice to the clinical study team(s) regarding the DM activities and deliverables.

2. Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization.

3. Provides input to the DM related activities associated with regulatory inspections/audits.

4. Provide DM business expertise and consultancy in the selection and use of software systems and vendors.

5. Contribute to DM processes and standards.

6. Ensure the quality and consistency with company strategies and standards across therapeutic areas.

7. Provide input into collection standards and processes based on industry best practices.

8. May be asked to provide strategic DM expertise to company Clinical Initiatives.

9. Management and oversight of vendor contracts, resourcing and budgets.

10. Reviews, assesses and manages DM delivery against KPIs and overall DM performance.

11. Provides input into the contract process for the Data Management.

12. Manages all Data Management timelines and DM Deliverables for assigned studies.

Operational Responsibilities:1. Accountable for the execution and overall quality of DM activities and deliverables.

2. Acts as the single point of contact for all data management for the study team during the study set-up phase, accountable for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.

3. Provide guidance and supervision to Lead Data Managers working on the study (CRO or in-house) and coordinate the data analysis team for on-time deliverables.

4. Accountable for “Real Time Data Management” (RTDM), ensuring that DM conducts initial reviews within 5 days (or agreed timeline) of a patient’s data entering the EDC system, and manages the average query aging to no more than 20 days (or agreed timeline).

5. Accountable for the overall quality and completeness of the Data Management Plan (DMP) and the Data Quality Plan (DQP).

6. Provide input on functional excellence activities.

Education, Qualifications, Skills and Experience:

1. Minimum of a BS in life sciences or computer science degree.

2. Strong Data Management experience in the Biotech/Pharma/CRO industry skills/abilities.

3. Demonstrated knowledge of clinical and pharmaceutical drug development process.

4. Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities.

5. Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP).

6. State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.

7. Be familiar with the “End to End” concept from protocol development to CSR generation.

8. Experience of clinical databases, different clinical data management systems and electronic data capture (EDC).

9. Demonstrated understanding of clinical data system design / development / validation and system interoperability.

10. Demonstrated leadership (including in an outsourced environment). Excellent understanding and demonstration of the DZ values and behaviour.

11. Demonstrated project management skills.

12. Strong communication and interpersonal skills.

13. Excellent organizational and analytical skills.

14. Ability to work independently.

15. Demonstrated ability to work effectively with external partners.

16. Ability to negotiate and influence others across functional areas.

17. Excellent written and verbal communication skill.

18. Effective problem and conflict solving skills.

19. Ability to work in a global team environment.

20. Ability to interact effectively with all levels of management.

21. High attention to detail and accuracy.