Manager, Clinical Data

Position Summary:

Under the direction of the Sr Director, Clinical, the Manager, Clinical Data Management will be responsible for clinical database design, validation and maintenance, as well as oversight of clinical data quality and integrity related to clinical studies. This position is responsible for managing the clinical data team and the clinical trial safety specialist.

 

Responsibilities:

• Ensure clinical trial data is collected, managed and reported clearly, accurately and securely;
• Establish and maintain policies and procedures (SOPs) for gathering, analyzing and reporting clinical data;
• Lead and manage team of data specialist(s)/coordinator(s);
• Manage the clinical trial safety specialist and work with external safety committees to ensure timely review of clinical data
• Ensure oversight of the general safety and safety compliance of Nuvaira’s sponsored clinical studies.
• Facilitate/manage safety specialist’s interaction with the clinical events committee and safety officer
• Resolve escalated issues arising from operations, in coordination with other functions and/or departments as required;
• Manage clinical data related vendors;
• Design clinical database for each clinical study;
• Develop clinical database specifications including CRFs/eCRFs in collaboration with the clinical team;
• Develop user requirements, edit checks, query logic/language in collaboration with the clinical team;
• Manage roles and permissions related to clinical database;
• Develop and manage eCRF completion and review guidelines and requirements;
• Develop and manage source worksheet templates;
• Develop plan for, lead, and oversee documentation of User Acceptance Testing;
• Develop Data Management Plan in collaboration with clinical team;
• Development of EDC training materials and documentation;
• Train clinical database end users (including internal staff, monitors, clinical centers) on the use of the clinical database;
• Develop pertinent clinical data reports as needed;
• Work closely with clinical team, including monitors, to ensure quality of clinical data through data review and query management;
• Manage and document changes to clinical database;
• Compile data outputs and transfer to biostatisticians;
• Execute database locks/freezes (as appropriate);
• Archive study data and study design documentation;
• Other related duties as required in support of company and departmental objectives.

 

Qualifications:

• B.S. in biological or medical/clinical sciences preferred with 8+ years of related experience in medical device clinical research
• 2+ years of managerial experience
• IDE Class III medical device experience
• Working knowledge of GCPs and regulatory requirements related to clinical research
• Working knowledge of data management practices
• Certified MERGE eCOS Designer preferred
• Strong organization skills and time management in a dynamic environment; ability to work on multiple projects
• Good critical thinking and sound communication skills
• Excellent computer skills including proficiency in Microsoft office
• Self-motivated and detailed oriented

 

 

 

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.

 

Apply by sending your resume to [email protected]