Position Summary: The Sr. Clinical Data Manager is responsible for overseeing clinical data quality and integrity related to clinical studies by designing, validating and maintaining user friendly, scientifically appropriate clinical databases, as well as participating in the review and analysis of clinical data.
- Oversee and participate in the development of clinical database design for each clinical study, including User Acceptance Testing, Query Logic and Language, Roles and Permissions and CRF completion guidelines and requirements
- In collaboration with the Clinical Study Manager (or designee) develop data management plans for clinical protocols;
- In collaboration with the clinical and science teams, develop data surveillance plans (as applicable) for clinical studies;
- Develop EDC training materials and documentation;
- Participate in data analysis with Science and Technology team and external statistical experts and consultants;
- Manage timelines associated with database design, data review and database locks/freezes;
- Work closely with the clinical team, including study managers, clinical monitors, etc. to ensure quality of clinical data through appropriate data collection and review;
- Generate and manage data management quality documentation including standard operating procedures (SOPs) and work instructions (WIs);
- Hire and manage clinical data team members.
- B.S. or B.A. in biological or medical/clinical sciences preferred with at least two years functioning as a lead data manager
- Working knowledge of GCPs and regulatory requirements related to clinical research
- Working knowledge of data management practices
- Strong organization skills and time management in a dynamic environment; ability to work on multiple projects
- Good critical thinking and sound communication skills
- Self-motivated and detailed oriented
- Willing and able to travel as necessary
- Experience working with all phases of study conduct: start-up, maintenance, and closeout.
- Experience with PMA submissions and clinical trial data audits.
- Experience writing SOPs and work instructions.
- Experience managing direct reports.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.