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Data Management Lead I (South Africa)

Parexel International Corporation

South Africa - Any Region - Home Based

Job Purpose. Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.

Major Activities

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

6. 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 guidelinesQualificationsEducation (minimum/desirable):

University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.

Languages:

Fluent English (oral and written).

Experience/Professional requirement:

1. Ability to work under pressure demonstrating agility through effective and innovative team leadership

2. Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders

3. Excellent problem solving skills

4. Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management

5. Excellent verbal and written skills

Job posted: 2022-02-24

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