Under supervision of the Clinical Data Manager, this position will be coordinating the delivery of data management services for multiple projects and ensuring data integrity and quality deliverables on time. The candidate will assist in the delivery of high quality data, by performing reconciliation of source documentation, data entry and routine Data QC within multiple clinical databases and information systems. The data coordinator will ensure, accuracy and adherence to applicable regulations, GCP and GDP and support the clinical data manager in establishing consistent practices. This position requires attention to detail and good organizational skills. The candidate must have the ability to establish and maintain effective working relationships with cross-functional teams. Duties may also include routine peer-to-peer quality review to ensure data integrity and contribute to process improvement. The Clinical Data Coordinator must follow study specific procedures and adherence to data management compliance and demonstrate thorough knowledge of the data management process.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Note: Other duties may be assigned.
Coordinate end-to-end delivery of data management services for multiple projects with some guidance, ensuring quality deliverables on time
Perform routine QC of data for multiple complex projects at various stages of data handling to ensure that all data are reliable and have been processed correctly (e.g., quality check of source data, databases and reports as required).
Establish strong communication with MIRTH team, LIMS team, test method leads, project managers and all other stakeholders
Communicate with Project Managers, LIMS team and test method leads on a regular basis to meet data management deliverables for multiple projects and ensure milestones meet timelines and quality deliverables
With minimal guidance, support Clinical Data Management (CDM) team with comprehensive CDM process and technical expertise in executing data projects
Perform data remediation and other efforts related to researching and updating incomplete or missing information
Perform extraction of data and generate required reports as requested
Work with project team to identify and resolve data issues
With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
May perform data entry of a significant amount of information from electronic or hardcopy source materials such as patient demographics, clinical raw data and testing results into electronic databases and spreadsheets in accordance with project requirements as necessary
Reviews and verifies source materials to determine accuracy and completeness of information; follows up to correct or complete data
Verifies data entered into the computer by checking printouts/reports for errors and correcting as required
Assist with identification and correction of data errors in accordance with quality assurance procedures
Adhere to standard operating procedures, protocols, and study specific guidelines
Ability to handle confidential material and adhere to data security and confidentiality requirements
Assist in logging and monitoring of physical location of source documents
Assist with study close-out activities to verify data integrity and data completeness
With guidance, prepares data validation documents and conducts data validation testing
Communicates with data management staff regularly on data management issues
Provide status updates related to project tasks to management as necessary
Perform tasks as assigned to assist with the smooth operation of the Clinical Data Management.
Provides general support to Clinical Data Management staff and project management teams
Managing the Clinical Data Management documents in MasterControl
May assist with preparing or reviewing work instructions.
May assist with preparing requirement/qualification documents and qualification testing for MIRTH channels.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Note: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience Required:
Bachelor of Science or Bachelor with 2 years of experience OR 3 year Clinical Data Management experience or Clinical Research Associate experience in lieu of degree
Knowledge of clinical research experience preferred
Demonstrated proficiency in data management and computer software applications (MS Word, Excel, Outlook)
Required Skill Sets & Knowledge
Comprehensive data management/ QC expertise
Experience in auditing clinical data for accuracy and compliance
Effective verbal communications skills
Ability to focus and complete repetitive tasks for an extended period of time
Strong time management skills
Knowledge of GCP guidelines and clinical trials
Strong attention to detail
Highly experienced in performing Quality review of clinical data
Flexibility and capability to multitask and meet established deadlines
Ability to prioritize and work with minimal supervision
Strong computer literacy and keyboard skills required
Ability to work with spreadsheets (such as Excel)
Accuracy in data entry
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.
The work environment involves moderate exposure to unusual elements including: extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company s Safety and Injury, Illness and Prevention Plans.
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