Sr. Manager, Clinical Data Management

Location

Aliso Viejo, California, USA

Department Name

807-CONFIDENCE

Qualifications

1. Bachelor’s degree in Science, Computer Science, or equivalent combination of training and experience.
2. Minimum seven (7) years of clinical data- management experience in the pharmaceutical, device or CRO setting.
3. Previous supervisory experience.
4. Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives.
5. Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans, Data Transfer Plans.

1. Well organized, analytical and self-confident person.
2. Solid experience in developing, implementing, and validating data management systems and Electronic Data Capture (EDC).
3. Strong communication skills and interpersonal skills, ability to coach and mentor.
4. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.
5. Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
6. Able to work independently, as well as part of a team.

External-Facing Title

Sr. Manager, Clinical Data Management

Posting Country

US - United States

Salary Range

$123,318 - $175,645 (Compensation could be higher based on education, experience and skill sets)