Clinical Data Manager

hace 2 semanas

Bogota, Colombia MSD A tiempo completo

**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

**Position Overview**:
Under the direction of the applicable management, the Clinical Data Manager 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 collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our company Standard Operating Procedures and guidelines.

**Primary activities include, but are not limited to**:

- Receives the study related paper documents from sites or other functional areas, and transfers to data entered for processing.
- Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.
- Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities
- Execute data validation activities in accordance with relevant Standard Operating Procedures.
- Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
- Responsible for the execution of user acceptance testing of data management tools under the guidance of the Senior Clinical Data Manager/Lead Clinical Data Manager. Escalates overdue items, including but not limited to outstanding questions and missing visits.
- Assists the Senior/Lead Clinical Data Manager with data management activities to resolve all identified data issues prior to study database lock.
- Complete trial level archiving activities under the direction of the Senior Clinical Data Manager/Lead Clinical Data Manager including, but not limited to, filing of essential documentation.

**Education**:
At least B.A. or B.S. degree, Nursing, Veterinary, Dentistry, Bacteriology, Pharmaceutical Chemistry, Biomedical Engineering and system engineering. Also, Biologist, microbiologist with clinical experience of 6 months. Also Chemical engineering with 1 year of formal experience.

**Knowledge and Skills**:
1. Self-motivated, excellent in work planning and time management.

2. Fluent oral and written English skills.

3. Good sense and awareness of regulations and policies.

4. Able to work under pressure and in a changing environment with flexibility.

5. Good communication skills with the ability to communicate with both the technical and business areas.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**What we look for**

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue **Inventing For Life, Impacting Lives** while **Inspiring Your Career Growth**.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R240984

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