SUMMARY: This position will act as the lead clinical data manager for clinical (Phase I-IV) trials as assigned. The person is responsible for providing input to protocols, design and review case reports forms, provide input to database development and perform all data management related activities. The person is expected to ensure that the clinical data management elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
RESPONSIBILITIES:
Represent clinical data management in meetings with internal cross-functional and external customers
Act as the Lead data management team member in clinical development
Perform or support data management activities for multiple studies in different indications. The responsibilities include CRF development, CRF review, database specifications, user acceptance testing, query resolution, data review and data completion.
Interact with clinical operations, medical monitors and biostatistics/Programming periodically on the progress on the data entry, and quality
Interact with external data management vendors and subsidiaries of Spectrum
POSITION LOCATION AND/OR TERRITORY AND TRAVEL
Required Skills Required Experience
Industry
- Data Management and Pharmacovigilance processes in clinical trials.
- Relational databases.
- Good clinical practices.
- 21CFR Part 11 standards.
- Safety data and coding dictionaries
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience:
High school diploma or general education degree (GED).
Language Ability:
Ability to read and comprehend simple instructions in English. Ability to write simple correspondence in English. Ability to effectively present information to one-on-one and small group situations to customers, clients, and other employees of the organization.
Math Ability:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability:
Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.
Computer Skills:
To perform this job successfully, an individual should have knowledge of E-mail and Lab Information System (will train).
Certificates and Licenses:
Selected Laboratory Assistants required to travel for their job must have a valid driver’s license and an acceptable driving history.