Job Description, Responsibilities & Requirements
About the Position
Intego Clinical’s Biometric Department, with its Branch offices in Armenia, is expanding its clinical data management practice. We are looking for bright individuals to join our growing team in the Yerevan office. As a Senior/Principal Clinical Data Manager, you will be responsible for all aspects of clinical database review, cleaning, reporting, participating in database design and implementation, as well as client communication and team oversight. You will establish and maintain policies and procedures for gathering, analyzing, and reporting clinical trial data.
Responsibilities
- Review clinical trial data in alignment with client SOPs and data review conventions to identify erroneous, missing, incomplete, or implausible data.
- Perform query production, resolution, and tracking to resolve any problematic data identified during the review. Update the database accordingly.
- Create and/or review data management documentation, completion guidelines, DMP, DVS, and other specifications.
- Take part in EDC system and CRF components design and testing.
- Interact with clinical, programming, and other project teams, as necessary.
- Communicate with the client/sponsor, leading the project.
- Team oversight and tasks planning.
Requirements
- Bachelor’s Degree, or educational equivalent, in health, clinical, biological, or related discipline, and 5 or more years of direct data management experience.
- Knowledge of medical terminology, pharmacology, anatomy, and/or physiology.
- Knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Knowledge of GCP and relevant regulatory guidelines.
- Strong English skills. Excellent communication, interpersonal, customer service, and teamwork skills.
- Excellent organizational and analytical skills.
- Comprehensive understanding of the clinical drug development process.
- Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications is preferred.
- Experience with an electronic data capture (EDC).
- Ability to maintain a high degree of confidentiality with clinical data and proprietary data.
- Ability to use interactive computer programs, such as MS Word, Excel, and PowerPoint.
Nice to Have
- Extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding of DM processes, SAE reconciliation/pharmacovigilance, medical review, external data vendor reconciliation, management of central/local laboratory data, and/or new technology).
We Offer
- Opportunity to join a growing team in a dynamic environment.
- Competitive benefits package.
- Professional development opportunities.
About the Company
Intego Clinical is a leading company in the clinical research industry, dedicated to providing high-quality clinical data management services. Our team is committed to excellence and innovation in clinical trials.