Role Summary:
The Clinical Data Manager (CDM) has a pivotal role in ensuring the integrity and quality of our clinical trial data. This position will collaborate closely with cross-functional teams running data management activities for multiple studies. The Clinical Data Manager (CDM) 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 company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
The CDM will be responsible for the review and delivery of high quality data for the clinical trials and ensuring timely delivery of complete, high quality clinical trial data deliverables. Essential Duties and Responsibilities:
- Serve as a Data Manager across multiple study projects and have contact with Clinical Study Teams and Data Management counterparts at Contract Resource Organizations.
- Liaise directly with internal team and external vendors to coordinate aspects of data management activities.
- Interact with the CRO and/or clinical sites for DM activities and deliverables in conjunction with the study team.
- Perform data review in EDC and patient profiles; issue queries as needed.
- Collaborate with cross-functional teams to ensure integrated cross-functional oversight of data integrity and quality.
- Ability to create customized data listings (via Excel or other tools) and trackers as needed to help with data-related deliverables.
- Communicates project status and vendor performance in relation to both quality and timelines. Contributes to risk mitigation or action plans where appropriate.
- Participates in the review of protocols and other study related documents as required.
- Participates in User Acceptance Testing (UAT) and documentation for assigned studies databases.
- Identify and implement data review initiatives/key quality indicators helping to ensure continuous oversight of data.
- Ensure compliance with industry quality standards, regulations, guidelines and procedures.
- Other duties as assigned.
Education and/or Work Experience Requirements:
- Minimum 3 years of clinical data management experience in Pharmaceutical/Biotechnology industry.
- BA/BS in scientific or health-related discipline preferred.
- Oncology trial experience strongly preferred and global/international experience a plus.
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and CDISC standards regarding drug development phases, clinical research and data management standards.
- Knowledge of general medical coding, including knowledge of medical dictionaries and coding tools preferred.
- Familiarity with data collection practices for laboratory results and reference ranges, clinical diagnostic procedures, and disease history and processes.
- Strong time management and organizational skills.
- Strong written and verbal communications skills.
- Highly motivated individual with theflexibility and creativity to excel in and contribute to a rapidly growing company.
Technical Skills:
- Proficiency in Microsoft Office Applications, especially Excel
- Strong familiarity with EDC, particularly Medidata RAVE preferred.
- Knowledge of data visualization tools or basic programming (SAS, R, Python) is a plus.
