Lead Clinical Data Manager

hace 3 días


Bogota, Colombia MSD A tiempo completo

**Job Description**:
**_ #ONEGDMS _**_Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource allocation. Supports the comprehensive development of junior staff and encourages effective interaction with business partners to achieve common objectives. Is accountable for the the quality and timely execution and delivery of deliverables at the trial level._

**_ Requirements:_**

**_ Education: _**
- _At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline._

**_ Knowledge and Skills: _**
- Previous experience (approximately _**_2_**_ years or more) in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required. _Minimum _**_6_**_ months as Senior Clinical Data Manager _Knowledge of database structures and available tools to manage, extract, and report data is preferred. _Fluent Oral and written English language skills._ _Knowledge of applicable regulations and policies. _Proficient overall working knowledge of the clinical development process._ _Good working knowledge of clinical practice and medical terminology._ _Ability to work cross functionally and as part of a team._ _Be able to work under pressure in a changing environment with flexibility._ _Ability to work independently and accept and act with appropriate accountability with mínimal guidance by manager. _Ability to coordinate the work of others and influence decision making. _Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas._ _Exceptional organizational, problem-solving and negotiating skills. _Demonstrated excellent project management and leadership skills._

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R233279


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