Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Clinical Data Manager to support the commercialization of its novel biomarker products.
JOB TITLE: Clinical Data Manager
REPORTS TO: Associate Director Data Management
Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, experienced, and self-motivated individual for the position of Clinical Data Manager (CDM).
The Clinical Data Manager will provide support to data management operations and is responsible for the organization, coordination and execution of data management activities for assigned studies. This includes but is not limited to database setup, development of study documents, training, data review, edit check creation and execution, query generation and resolution, assist in the development of data entry guidelines and conventions, and overall maintenance of study database to ensure data integrity from study startup to database lock.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manage the delivery of high quality data from study start through execution and study closeout on several projects.
- Lead data quality control and quality assurance processes and manage the query resolution process for assigned studies.
- Participate in the development and review of clinical protocols to support CRF development.
- Contribute to the design of CRFs as well as study databases.
- Participate in the development of study databases and validation & derivation procedures and documentation of their specifications.
- Develop CRF guidelines and data management plans.
- Perform testing and validation of databases and data entry screens to ensure compliance with protocol and procedures.
- Develop training material and provide EDC training for internal users and site personnel.
- Identify project-specific reports and data listings and assist in their development.
- Assist with the coding of medical histories and concomitant medications.
- Support clinical per GCP and ICH standards and regulations.
- Communicate project status and key issues to management.
- Interacts with third-party vendors such as CROs, supply vendors and central laboratories to carry out data management or clinical operations tasks for clinical studies.
- Participates in the identification, review and evaluation of new data management technologies.
- Performs sample reconciliation of clinical samples, identifies discrepancies and oversees resolution of discrepancies.
- Provide assistance in the development and maintenance of Standard Operating Procedures (SOPs) and Process Guides related to data management activities.
- Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
- Responsible for ensuring compliance with applicable Astute Medical policies and procedures across the organization.
- Performs other duties & projects as assigned.
- BA / BS Degree in related field, or an equivalent combination of education and work experience, preferred.
- At least 6 years of hands on experience in data management activities for multiple and/or complex clinical studies, preferred.
- Good knowledge of clinical trials design, methodologies, and data flow.
- Experience with web-based Electronic Data Capture (EDC) – preferred.
- Familiarity with relational databases.
- Knowledge of industry standards and applicable regulatory rules and guidelines; e.g. ICH and GCP.
- Working knowledge of Microsoft Office (Word, Excel, PowerPoint and Access).
- Excellent interpersonal and communication skills (written and verbal).
- Ability to prioritize projects and workloads.
While performing the duties the employee is:
- Constantly required to reach computers and other office and laboratory equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
- Frequently required to sit
- Frequently required to stand
- Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
- May occasionally be required to travel to meetings and tradeshows
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.
Primary Location: AMER-AMER-US-CA-San Diego, CA
Job Posting: Feb 11, 2019, 5:12:40 PM
Shift: Day Job
Employee Status: Regular
Travel: Yes, 25% of the time