Senior Clinical Trial Manager, Oncology, Colombia
hace 6 meses
Required:
**3+ years of Clinical Trial Management experience (CRO experience preferred).**
**Experience managing clinical trials in LATAM and North America required**
**Oncology experience related to managing studies**
**Fluent in English, both writing and verbally**
**Preferred**:
**Experience managing global studies**
**Experience managing studies in other therapeutic areas such as Cardiovascular and Internal Medicine**
**Please submit an English version of resume to be considered.**
**BASIC FUNCTIONS**:
Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.
**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:
Responsible for all activities related to implementation and execution of clinical studies that include:
Internal/External Stakeholder
Coordinate site management activities
Coordinate and oversee daily operations of clinical monitoring team
Manage project milestones and proactively address deficiencies
Manage CRA performance
Documentation
Budget and Contract Responsibilities
**KNOWLEDGE, SKILLS & ABILITIES**:
- Thorough knowledge of clinical research process.
- Strong communication skills (verbal and written) to express complex ideas.
- Excellent organizational and interpersonal skills.
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
- Ability to manage multiple priorities within various clinical trials.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Understanding of basic data processing functions, including electronic data capture.
- Working knowledge of current ICH GCP guidelines and applicable regulations.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of Word and Excel.
- Prior experience in electronic data capture (EDC) preferred.
- Able to mentor CRAs and more junior Clinical Trial Managers.
- Able to qualify for a major credit card.
- Valid driver’s license; ability to rent automobile.
- Willingness and ability to travel domestically and internationally, as required.
**CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA**:
- Ability to travel domestically and internationally
- Very limited physical effort required to perform normal job duties
**MINIMUM RECRUITMENT STANDARDS**:
- BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
- Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
- Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager
- Equivalent combination of education, training and experience
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