Associate Clinical Data Manager in Saint Petersburg, Russia
Location: Saint Petersburg, St.-Petersburg, Russia
Requisition Number: 2189
Position Title: Associate Clinical Data Manager
SUMMARY: The Clinical Data Management Associate, under the guidance and supervision of the Manager, Clinical Data Department, is responsible for monitoring, management and processing of clinical data to ensure quality and integrity of the overall conduct of clinical trials.
Tasks may include but are not limited to:
- Always represents Worldwide in a professional manner (verbal, written and in appearance) when interacting with Sponsors, volunteers, outside vendors and fellow employees.
- Review study protocol and supporting documents for each study.
- Regularly attend study initiation visits and study planning meetings.
- Monitor data collection real time and post collection for quality and completeness.
- Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues.
- Provide support and training for staff utilizing the database.
- Manages archival of clinical trial documents (paper and electronic records) and complete requests for on-site and off-site archive.
- Prepares documents for final study report inclusion and assists in managing any identified discrepancies.
- Develops understanding of ICH-GCP Guidelines.
- Responsible for requesting, scheduling and completing any training required for this position.
- Identifies areas for process improvement and provides information to management.
- Performs additional assignments as warranted by upcoming and ongoing clinical research studies.
- Performs other duties as assigned.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Excellent written and oral communication skills.
- Ability to understand complex written and oral instructions.
- Computer systems and applications knowledge
- Strong interpersonal skills.
- Excellent attention to detail.
- Exceptional organizational skills.
- Ability to set and meet multiple deadlines
- Knowledge of the clinical research process, including Good Clinical Practice
- Possible equipment includes, but is not limited to: computers, rolling carts, fax machines, photocopiers, telephone, mop/broom, scales, calculators, vital signs equipment, ECG equipment, and other medical equipment.
Required: Bachelor’s degree with at least 2 years of clinical research experience within Data Management department.
Preferred: Bachelor’s degree (preferably in the field of Health); at least 3 years of clinic research experience and/or experience with Regulatory documents and/or Quality Control/Quality Assurance in the clinical research field.
Employment Type: Regular
Community / Marketing Title: Associate Clinical Data Manager in Saint Petersburg, Russia
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: St. Petersburg, RU